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 Absolute Pro™ Peripheral Self-Expanding Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Interventions
DEVICEAbsolute Pro™ Peripheral Self-Expanding Stent System
Absolute Pro™ Peripheral Self-Expanding Stent System: Devices include both Absolute Pro™ and Absolute Pro™ LL Peripheral Self-Expanding Stent Systems. It is indicated for the 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
NON_RANDOMIZED
Intervention model
PARALLEL
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) Rate | 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 index procedure. | Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of \< 30% by QA or as reported by the investigator, if QA is not available. |
| Procedure Success | Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner | Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) 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) | Post-procedure | The changes in thigh brachial index is the ratio of 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). |
| 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 |
| Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 1 month and 9 months | The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. |
| 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 | Target lesion revascularization was 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). |
| Device Success | acute: from beginning of index procedure to end of index 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 Target Vessel Revascularization (TVR) for the Treated Limb(s) | 1 month and 9 months | Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: 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 | 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 | 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 Embolic Events | 1 month and 9 months | Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery. |
| Stent Thrombosis | 1 month | Stent thrombosis is defined as a total occlusion documented by DUS 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 Amputations (Major) of the Treated Limb(s) | 1 month and 9 months | Amputation is defined as 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; a major amputation will be defined as at or above the ankle. |
Countries
United States
Participant flow
Recruitment details
Trial population is comprised of male and female subjects with moderate to severe iliac artery atherosclerotic occlusive disease. Recruitment dates: March 23, 2009 through May 17, 2010
Participants by arm
| Arm | Count |
|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification. | 151 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 16 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | Absolute Pro™ Peripheral Self-Expanding Stent System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 66 Participants |
| Age, Categorical Between 18 and 65 years | 85 Participants |
| Age, Continuous | 62.8 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 151 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 88 / 151 |
| serious Total, serious adverse events | 91 / 151 |
Outcome results
Primary
Major Adverse Event (MAE) Rate
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Major Adverse Event (MAE) Rate | 6.1 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: Between baseline and 9 months
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by >/= 3 categories | 47.3 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 2 categories | 29.1 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 1 category | 17.6 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | No change | 6.1 Percentage of 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 3 years
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by >/= 3 categories | 56.6 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 2 categories | 23.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 1 category | 15.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | No change | 5.3 Percentage of 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 2 years
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by >/= 3 categories | 52.9 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 2 categories | 19.8 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 1 category | 21.5 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | No change | 3.3 Percentage of 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.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by >/= 3 categories | 42.2 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 2 categories | 30.4 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | Improved by 1 category | 18.6 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s) | No change | 8.1 Percentage of 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. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Quality of Life Measures: Mental Component Summary | 1.9 scores on a scale | Standard Deviation 10.4 |
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 1 month
Population: ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Quality of Life Measures: Mental Component Summary | 3.9 scores on a scale | Standard Deviation 10.9 |
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. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Quality of Life Measures: Mental Component Summary | 2.7 scores on a scale | Standard Deviation 12.4 |
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. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Quality of Life Measures: Mental Component Summary | 2.2 scores on a scale | Standard Deviation 13.4 |
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. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Quality of Life Measures: Physical Component Summary | 9.5 scores on a scale | Standard Deviation 12.5 |
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. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Quality of Life Measures: Physical Component Summary | 9.9 score on a scale | Standard Deviation 11.2 |
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. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Quality of Life Measures: Physical Component Summary | 8.9 scores on a scale | Standard Deviation 11.6 |
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. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Quality of Life Measures: Physical Component Summary | 10.0 scores on a scale | Standard Deviation 12.9 |
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: 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 (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding 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: 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 (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.2 Ratio | Standard Deviation 0.3 |
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: Post-procedure
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding 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: 1 month
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.3 Ratio | Standard Deviation 0.3 |
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: 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 (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Changes in Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.3 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 index procedure.
Population: Intent to treat (ITT) population. Included 192 study stents implanted plus 1 study stent inserted in subjects vasculature, but not implanted due to device malfunction. 1 study stent was excluded from device success because the chosen size was not appropriate, therefore the stent was not implanted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Device Success | 96.4 percentage of devices |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Amputation is defined as 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; 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 time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 1 month | 100 percentage of limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 9 months | 99.4 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Amputation is defined as 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; 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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 99.4 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Amputation is defined as 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; 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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 99.4 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Amputation is defined as 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; 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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s) | 99.4 percentage of 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 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 timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 91.4 percentage of target lesions |
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) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 1 month | 100 percentage of target lesions |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 9 months | 97.1 percentage of target lesions |
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 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 timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 86.9 percentage of target lesions |
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 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 timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR) | 94.7 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
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 the target vessel who were event free at this timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) | 1 month | 100 percentage of target vessels |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) | 9 months | 97.1 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
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 the target vessel who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) | 94.3 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
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 the target vessel who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) | 95.1 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
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 the target vessel who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s) | 97.1 percentage of target vessels |
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 time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Death (All Cause) | 1 month | 100 percentage of participants |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Death (All Cause) | 9 months | 96.1 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: 2 years
Population: ITT population.This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Death (All Cause) | 92.3 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: 3 years
Population: ITT population. This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Death (All Cause) | 88.3 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: 18 months
Population: ITT population. This analysis represents those subjects who were event free at this time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding 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
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 time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 98.7 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Embolic Events
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 98.7 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Embolic Events
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 98.7 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Embolic Events
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 time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 1 month | 99.3 percentage of participants |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Embolic Events | 9 months | 98.7 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 97.1 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 96.2 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
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 time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 1 month | 100 percentage of participants |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 9 months | 98.6 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI) | 97.9 percentage of participants |
Secondary
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 93.0 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
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) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 1 month | 99.4 percentage of limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 9 months | 97.7 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 96.6 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s) | 95.3 percentage of limbs |
Secondary
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Target lesion revascularization was 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) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 1 month | 100 percentage of target lesions |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 9 months | 95.6 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Target lesion revascularization was 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 timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 84.4 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Target lesion revascularization was 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 timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 89.6 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Target lesion revascularization was 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 timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR) | 93.5 percentage of target lesions |
Secondary
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: 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 the target vessel who were event free at this timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 1 month | 100 percentage of target vessels |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 9 months | 96.5 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: 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 the target vessel who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 94.5 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: 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 the target vessel who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 92.2 percentage of target vessels |
Secondary
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: 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 the target vessel who were event free at this timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s) | 96.5 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: 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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Primary Stent Patency | 80.7 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: 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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Primary Stent Patency | 90.9 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. The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Primary Stent Patency | 98.3 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: 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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Primary Stent Patency | 75.2 percentage of limbs |
Secondary
Procedure Success
Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Procedure Success | 85.4 percentage of participants |
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Restenosis | 8.4 percentage of limbs |
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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Restenosis | 16.9 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) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Restenosis | 20.3 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.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 0.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 0.6 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 28.2 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 63.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 8.3 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 0.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.0 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: 9 months
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 60.1 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 23.6 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 14.2 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 2.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 0.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 0.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.0 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: 1 month
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 54.7 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 26.7 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 15.5 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 2.5 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 0.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 0.6 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.0 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: 3 years
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 69.9 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 18.6 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 9.7 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 1.8 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 0.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 0.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.0 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: 2 years
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 0 | 61.2 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 1 | 25.6 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 2 | 7.4 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 3 | 4.1 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 4 | 0.0 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 5 | 1.7 Percentage of Limbs |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Rutherford Becker Clinical Category for the Treated Limb(s) | 6 | 0.0 Percentage of Limbs |
Secondary
Stent Thrombosis
Stent thrombosis is defined as a total occlusion documented by DUS 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.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Stent Thrombosis | 0.6 percentage of limbs |
Secondary
Technical Success
Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of \< 30% by QA or as reported by the investigator, if QA is not available.
Time frame: acute: from beginning of index procedure to end of index procedure.
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Technical Success | 87.3 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: Post-procedure
Population: Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding 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: 3 years
Population: Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 1.1 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: 2 years
Population: Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding 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: Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 1.1 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: Per target limb analysis.ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 1.1 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: Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Thigh Brachial Index (TBI) for the Treated Limb(s) | 0.8 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).
Time frame: 1 month
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Distance Score (N=134) | 53.8 scores on a scale | Standard Deviation 37.6 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Speed Score (N=135) | 51.8 scores on a scale | Standard Deviation 33.5 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Stair Climbing Score (N=127) | 55.9 scores 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).
Time frame: 9 months
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Distance Score (N=127) | 55.7 scores on a scale | Standard Deviation 39.6 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Speed Score (N=126) | 50.6 scores on a scale | Standard Deviation 33.9 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Stair Climbing Score (N=119) | 59.2 scores on a scale | Standard Deviation 37.5 |
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).
Time frame: Pre-procedure
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Distance Score | 14.0 score on a scale | Standard Deviation 19.9 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Speed Score | 17.9 score on a scale | Standard Deviation 20.8 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Stair Climbing Score | 22.7 score on a scale | Standard Deviation 23.9 |
Secondary
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ)
Time frame: 2 years
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Distance Score (N=99) | 58.2 scores on a scale | Standard Deviation 37.1 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Speed Score (N=99) | 50.6 scores on a scale | Standard Deviation 32.4 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Stair Climbing Score (N=95) | 59.1 scores on a scale | Standard Deviation 36 |
Secondary
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ)
Time frame: 3 years
Population: ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Speed Score (N=94) | 49.2 scores on a scale | Standard Deviation 33 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Walking Distance Score (N=94) | 54.1 scores on a scale | Standard Deviation 40 |
| Absolute Pro™ Peripheral Self-Expanding Stent System | Walking Impairment Questionaire Scores | Stair Climbing Score (N=88) | 58.9 scores on a scale | Standard Deviation 37.2 |