Peripheral Vascular Disease
Conditions
Keywords
Atherosclerosis, Peripheral artery disease, Peripheral vascular disease, PAD, Claudication, Peripheral Arterial Occlusive Disease, Stent, PAOD, PVD
Brief summary
To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Detailed description
The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study. The 2 arms (Omnilink Elite arm and Absolute Pro arm) were designed to independently assess the safety and effectiveness of the 2 devices used in this study.
Interventions
DEVICEOmnilink Elite™ Peripheral Balloon-Expandable Stent System
Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Subject must be at least 18 and \< 90 years of age. 2. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form. 3. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site. 4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4). 5. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months. Angiographic Inclusion Criteria 1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side). 2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion) 3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis 4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro) 5. Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm 6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro) 7. On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as \< 50% stenosis. 8. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite). 9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite). Clinical
Exclusion criteria
1. Subject is unable to walk. 2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery. 3. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver). 4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6. 5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s). 6. Subject has elevated serum creatinine \> 2.0 mg/dl. 7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose \> 400 mg/dl). 8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days. 9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk. 10. Subject has unstable angina defined as rest angina with ECG changes. 11. Subject has a groin infection, or an acute systemic infection that is currently under treatment. 12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity. 13. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure. 14. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited life-expectancy (i.e., less than 2 years). 15. Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints. 16. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits. 17. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication. 18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®). 19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions. 20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy. 21. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication. 22. Requirement of general anesthesia or spinal block for the procedure. 23. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic. 24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion. 25. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary. 26. Target lesion is in an iliac artery that has been previously stented. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Event (MAE) | 9 months | Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Acute: from beginning of index procedure to end of procedure | Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of \< 30% by QA or as reported by the investigator. |
| Procedure Success | Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner | Procedure success is defined as technical success (device success and attainment of a final residual stenosis of \< 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner. |
| Thigh Brachial Index (TBI) for the Treated Limb(s) | Pre-procedure | The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3. |
| Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) | Between baseline and Post-procedure | The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure. |
| Walking Impairment Questionaire Scores | Pre-procedure | Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity. |
| Rutherford Becker Clinical Category for the Treated Limb(s) | Pre-Procedure | The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable |
| Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Between baseline and 1 month | Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement. |
| Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 1 month and 9 months | Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion). |
| Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 1 month and 9 months | Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel). |
| Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 1 month and 9 months | Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel). |
| Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) | 1 month and 9 months | Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography). |
| Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s) | 18 months | Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography) |
| Device Success | Acute: from beginning of index procedure to end of procedure | On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s). |
| Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s) | 3 years | Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography). |
| Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 1 month and 9 months | Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category). |
| Primary Stent Patency | 1 month | Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure. |
| Restenosis | 9 months | Defined as ≥ 50% stenosis at follow-up. |
| Kaplan-Meier Estimate of Freedom From Death (All Cause) | 1 month and 9 months | Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years |
| Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 1 month and 9 months | Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. |
| Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 1 month and 9 months | Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle. |
| Kaplan-Meier Estimate of Freedom From Embolic Events | 1 month and 9 months | Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery. |
| Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) | 1 month and 9 months | Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle. |
| Stent Thrombosis | 1 month | Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure. |
| Changes in Quality of Life Measures: Physical Component Summary | Baseline and 1 month | This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. |
| Changes in Quality of Life Measures: Mental Component Summary | Baseline and 1 month | This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. |
| Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s) | 2 years | Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography). |
Countries
United States
Participant flow
Recruitment details
Subjects with chronic lower extremity peripheral arterial disease (PAD) admitted for percutaneous CIA or EIA revascularization were screened for eligibility. Subjects who met all general and clinical eligibility criteria, and signed the informed consent, underwent arteriography of the target iliac artery.
Participants by arm
| Arm | Count |
|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side). | 153 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 14 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Omnilink Elite™ Peripheral Balloon-Expandable Stent System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 66 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants |
| Age, Continuous | 63.9 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 153 participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 84 / 153 |
| serious Total, serious adverse events | 94 / 153 |
Outcome results
Primary
Major Adverse Event (MAE)
Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).
Time frame: 9 months
Population: Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Major Adverse Event (MAE) | 5.4 percentage of participants |
Secondary
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time frame: Baseline and 3 years
Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by >/= 3 categories | 38.8 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 2 categories | 33.1 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 1 category | 15.1 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | No Change | 11.5 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 1 category | 0.7 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 2 categories | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by >/= 3 categories | 0.7 percentage of target limbs |
Secondary
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time frame: Between baseline and 9 months
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by >/= 3 categories | 34.6 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 2 categories | 41.2 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 1 category | 13.2 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | No change | 7.1 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 1 category | 3.8 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 2 categories | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 3 categories or more | 0.0 percentage of target limbs |
Secondary
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time frame: Between baseline and 1 month
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by >/= 3 categories | 36.1 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 2 categories | 34.4 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 1 category | 18.9 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | No change | 8.9 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 1 category | 1.7 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 2 categories | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 3 categories or more | 0.0 percentage of target limbs |
Secondary
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time frame: Baseline and 2 years
Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by >/= 3 categories | 35.4 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 2 categories | 37.5 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 1 category | 16.7 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | No change | 9.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 1 category | 1.4 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by 2 categories | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Worsened by >/= 3 categories | 0.0 percentage of target limbs |
Secondary
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 9 months
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Quality of Life Measures: Mental Component Summary | 0.9 score on a scale | Standard Deviation 11.7 |
Secondary
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 1 month
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Quality of Life Measures: Mental Component Summary | 2.3 score on a scale | Standard Deviation 10.7 |
Secondary
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 3 years
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Quality of Life Measures: Mental Component Summary | -0.5 score on a scale | Standard Deviation 13.4 |
Secondary
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 2 years
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Quality of Life Measures: Mental Component Summary | 2.2 score on a scale | Standard Deviation 12.1 |
Secondary
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 9 months
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Quality of Life Measures: Physical Component Summary | 9.8 score on a scale | Standard Deviation 11.5 |
Secondary
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 1 month
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Quality of Life Measures: Physical Component Summary | 10.4 score on a scale | Standard Deviation 11.3 |
Secondary
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 3 years
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Quality of Life Measures: Physical Component Summary | 8.9 score on a scale | Standard Deviation 13.7 |
Secondary
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 2 years
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Quality of Life Measures: Physical Component Summary | 8.2 score on a scale | Standard Deviation 12.7 |
Secondary
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between Baseline and 1 month
Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.2 Ratio | Standard Deviation 0.2 |
Secondary
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between baseline and Post-procedure
Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.2 Ratio | Standard Deviation 0.2 |
Secondary
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between baseline and 9 months
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.1 Ratio | Standard Deviation 0.2 |
Secondary
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between baseline and 2 years
Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.2 Ratio | Standard Deviation 0.2 |
Secondary
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between baseline and 3 years
Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.2 Ratio | Standard Deviation 0.2 |
Secondary
Device Success
On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).
Time frame: Acute: from beginning of index procedure to end of procedure
Population: ITT population, per device analysis. Included 210 stents plus 1 stent inserted but not implanted due to device malfunction, 2 stents excluded due to inappropriate sizing (stents were not implanted), 1 stent excluded as stent was not implanted per physician's choice and had no device malfunction.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Device Success | 98.6 percentage of devices |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time frame: 3 years
Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 99.4 percentage of target limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time frame: 1 month and 9 months
Population: ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 1 month | 100.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 9 months | 100.0 percentage of target limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time frame: 18 months
Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 100 percentage of target limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time frame: 2 years
Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 100 percentage of target limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time frame: 1 month and 9 months
Population: ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) | 1 month | 100.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) | 9 months | 100.0 percentage of target limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time frame: 2 years
Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) | 100.0 percentage of target limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time frame: 3 years
Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) | 99.4 percentage of target limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time frame: 18 months
Population: ITT population.This analysis represents those subjects with target limbs who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s) | 100.0 percentage of target limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).
Time frame: 1 month and 9 months
Population: ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 1 month | 99.5 percentage of target lesions |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 9 months | 97 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).
Time frame: 3 years
Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 90.8 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).
Time frame: 2 years
Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 93.1 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).
Time frame: 18 months
Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 95.3 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time frame: 1 month and 9 months
Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) | 1 month | 99.5 percentage of target vessels |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) | 9 months | 99.5 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography)
Time frame: 18 months
Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s) | 99 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time frame: 2 years
Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s) | 98.4 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time frame: 3 years
Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s) | 96.6 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.
Time frame: 3 years
Population: ITT population.This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Death (All Cause) | 90.2 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Time frame: 1 month and 9 months
Population: ITT population. This analysis represents those subjects who were event free at this timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Death (All Cause) | 1 month | 100 percentage of participants |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Death (All Cause) | 9 months | 99.3 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.
Time frame: 2 years
Population: ITT population. This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Death (All Cause) | 93.8 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.
Time frame: 18 months
Population: ITT population. This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Death (All Cause) | 94.5 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Embolic Events
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time frame: 1 month and 9 months
Population: ITT population.This analysis represents those subjects who were event free at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 1 month | 99.3 percentage of particpants |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 9 months | 98.0 percentage of particpants |
Secondary
Kaplan-Meier Estimate of Freedom From Embolic Events
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time frame: 18 months
Population: ITT population.This analysis represents those subjects who were event free at this timepoint
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 98 percentage of particpants |
Secondary
Kaplan-Meier Estimate of Freedom From Embolic Events
Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time frame: 2 years
Population: ITT population.This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 97.3 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Embolic Events
Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time frame: 3 years
Population: ITT population.This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 96.5 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time frame: 18 months
Population: ITT population. This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 97.2 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time frame: 1 month and 9 months
Population: ITT population. This analysis represents those subjects who were event free at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 1 month | 100.0 percentage of participants |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 9 months | 99.3 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time frame: 3 years
Population: ITT population.This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 95.7 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time frame: 2 years
Population: ITT population.This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 95.7 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time frame: 2 years
Population: ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 94.1 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time frame: 18 months
Population: ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 95.8 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time frame: 3 years
Population: ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 94.1 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time frame: 1 month and 9 months
Population: ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 1 month | 99.5 percentage of limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 9 months | 98.0 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time frame: 3 years
Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 87.6 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time frame: 1 month and 9 months
Population: ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 1 month | 99.0 percentage of target lesions |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 9 months | 95.5 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time frame: 18 months
Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 93.9 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time frame: 2 years
Population: ITT population. This analysis represents those subjects with target lesions who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 90.5 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time frame: 18 months
Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 98.0 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time frame: 1 month and 9 months
Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 1 month | 99.0 percentage of target vessels |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 9 months | 98.5 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time frame: 3 years
Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 95.6 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time frame: 2 years
Population: ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 97.4 percentage of target vessels |
Secondary
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time frame: 9 months
Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Primary Stent Patency | 89.9 percentage of limbs |
Secondary
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time frame: 1 month
Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Primary Stent Patency | 97.3 percentage of limbs |
Secondary
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure
Time frame: 2 years
Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Primary Stent Patency | 76.7 percentage of limbs |
Secondary
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure
Time frame: 3 years
Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Primary Stent Patency | 68.4 percentage of limbs |
Secondary
Procedure Success
Procedure success is defined as technical success (device success and attainment of a final residual stenosis of \< 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.
Time frame: Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner
Population: ITT population, per subject analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Procedure Success | 91.5 percentage of participants |
Secondary
Restenosis
Defined as ≥ 50% stenosis at follow-up.
Time frame: 2 years
Population: ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Restenosis | 20.8 percentage of limbs |
Secondary
Restenosis
Defined as ≥ 50% stenosis at follow-up.
Time frame: 3 years
Population: ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Restenosis | 27.0 percentage of limbs |
Secondary
Restenosis
Defined as ≥ 50% stenosis at follow-up.
Time frame: 9 months
Population: ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Restenosis | 9.7 percentage of limbs |
Secondary
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: Pre-Procedure
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 43.8 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 54.7 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 1.5 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.0 percentage of target limbs |
Secondary
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: 3 years
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 64.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 16.5 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 15.1 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 3.6 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.7 percentage of target limbs |
Secondary
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: 2 years
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 66.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 16.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 15.3 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 2.8 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.0 percentage of target limbs |
Secondary
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: 9 months
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 59.9 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 23.6 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 11.5 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 4.4 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 0.5 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.0 percentage of target limbs |
Secondary
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: 1 month
Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 57.8 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 23.9 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 15.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 3.3 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 0.0 percentage of target limbs |
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.0 percentage of target limbs |
Secondary
Stent Thrombosis
Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.
Time frame: 1 month
Population: ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Stent Thrombosis | 0.5 percentage of target lesions |
Secondary
Technical Success
Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of \< 30% by QA or as reported by the investigator.
Time frame: Acute: from beginning of index procedure to end of procedure
Population: ITT population, per lesion analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Technical Success | 93.1 percentage of target lesions |
Secondary
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: 2 years
Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 1.0 Ratio | Standard Deviation 0.1 |
Secondary
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: 3 years
Population: ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 1.0 Ratio | Standard Deviation 0.2 |
Secondary
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: 9 months
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 1.0 Ratio | Standard Deviation 0.2 |
Secondary
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: 1 month
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 1.0 Ratio | Standard Deviation 0.1 |
Secondary
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: Post-Procedure
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 1.0 Ratio | Standard Deviation 0.2 |
Secondary
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: Pre-procedure
Population: ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.9 Ratio | Standard Deviation 0.2 |
Secondary
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: Pre-procedure
Population: ITT population, per subject analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Walking Impairment Questionaire Scores | 17.5 score on a scale | Standard Deviation 22.7 |
| Walking Speed Score | Walking Impairment Questionaire Scores | 20.1 score on a scale | Standard Deviation 24 |
| Stair Climbing Score | Walking Impairment Questionaire Scores | 26.0 score on a scale | Standard Deviation 25.8 |
Secondary
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: 1 month
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Walking Impairment Questionaire Scores | 56.4 score on a scale | Standard Deviation 38 |
| Walking Speed Score | Walking Impairment Questionaire Scores | 50.4 score on a scale | Standard Deviation 34.4 |
| Stair Climbing Score | Walking Impairment Questionaire Scores | 56.1 score on a scale | Standard Deviation 36.7 |
Secondary
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: 9 months
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Walking Impairment Questionaire Scores | 56.6 score on a scale | Standard Deviation 38.6 |
| Walking Speed Score | Walking Impairment Questionaire Scores | 47.6 score on a scale | Standard Deviation 33.2 |
| Stair Climbing Score | Walking Impairment Questionaire Scores | 60.4 score on a scale | Standard Deviation 35.9 |
Secondary
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: 2 years
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Walking Impairment Questionaire Scores | 49.1 score on a scale | Standard Deviation 37.9 |
| Walking Speed Score | Walking Impairment Questionaire Scores | 44.5 score on a scale | Standard Deviation 31.1 |
| Stair Climbing Score | Walking Impairment Questionaire Scores | 51.7 score on a scale | Standard Deviation 33.8 |
Secondary
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: 3 years
Population: ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omnilink Elite™ Peripheral Balloon-Expandable Stent System | Walking Impairment Questionaire Scores | 46.8 score on a scale | Standard Deviation 37.1 |
| Walking Speed Score | Walking Impairment Questionaire Scores | 41.8 score on a scale | Standard Deviation 30.4 |
| Stair Climbing Score | Walking Impairment Questionaire Scores | 55.4 score on a scale | Standard Deviation 34.9 |