Superficial Femoral Artery Stenosis
Conditions
Keywords
SFA, Stent, Popliteal, infrainguinal, LifeStent, Peripheral, Arterial
Brief summary
The objectives of this study are to collect post-market confirmatory evidence of the safety and effectiveness of the Bard® LifeStent® Vascular Stent System and LifeStent® XL Vascular Stent System (together the LifeStent® Vascular Stent System).
Detailed description
The study is a prospective, multi-center, single-arm, non-randomized study enrolling up to 234 subjects with lifestyle-limiting claudication or ischemic rest pain attributable to lesion(s) (stenosed, occluded, restenosed, or re-occluded) in the infra-inguinal segment (Superficial femoral artery \[SFA\] and/or proximal popliteal artery) that are amenable to treatment by percutaneous transluminal angioplasty (PTA) and stenting. All subjects enrolled in the study will receive PTA and stenting.
Interventions
DEVICEPTA followed by placement of LifeStent® Vascular Stent
PTA followed by placement of LifeStent® Vascular Stent
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site. 2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits. 3. The subject is ≥ 21 years old. 4. Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening. 5. The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category 2-4. 6. The target lesion(s) has angiographic evidence of stenosis or restenosis ≥ 50% or occlusion (by visual estimate) and is amenable to PTA with stenting. 7. The total target lesion(s) length must be ≤ 240 mm. 8. The target vessel reference diameter is ≥ 4.0 mm and ≤ 6.5 mm (by visual estimate), and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.
Exclusion criteria
1. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits. 2. The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss. 3. The subject has multiple stenoses or occlusions \> 240 mm. 4. The subject has a previous stent or stent graft located in the target vessel. 5. The subject has flow-limiting stenosis or occlusion of the inflow tract that cannot be adequately corrected (≤ 30% residual stenosis) prior to treatment of the target lesion(s). Investigator standard of care practices shall be utilized for treatment of inflow. 6. The subject has a known contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, tantalum or sensitivity. 7. The subject has a known contraindication to contrast media that is not amenable to pretreatment with steroids or/and antihistamines. 8. The subject has a known history of bleeding diatheses or coagulopathy. 9. The subject has concomitant renal failure with a creatinine of \> 2.5 mg/dL. 10. The subject is currently on dialysis or receiving systemic immunosuppressive therapy. 11. The subject has known concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus, septicemia or deep vein thrombosis at the time of the index procedure. 12. The subject is currently participating in an investigational drug or another investigational device study that has not completed the primary endpoint, or that clinically interferes with the study endpoints. Note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 13. The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up. 14. The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath. 15. The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s). 16. There is angiographic evidence of unresolved thrombus at the target lesion(s) or within the target vessel that does not resolve with infusion of thrombolytics and/or mechanical thrombectomy (using an approved device) without adverse events/complications. 17. The subject has undergone any non-iliac percutaneous intervention(s) \< 7 days prior to the index procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure. | 30-days and 12-months | Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure. |
| Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure | At time of procedure (acute) and 12-months post-index procedure (Chronic) | The primary effectiveness endpoint of the study, device success, collectively measured both acute and chronic effectiveness. Acute effectiveness is defined as successful delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length. Chronic effectiveness is defined as Primary Target Lesion Patency (TLP) at 12-months post-index procedure, as measured by Duplex Ultrasound (DUS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm. | 30-days and 12-months Post -Index Procedure | • Primary Safety (freedom from occurrence of death at 30-days and 12-months post-index procedure) of the Target Lesion Lengths \> 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup. |
| Freedom From Fracture at 12 and 24-Months Post-Index Procedure | 12- and 24-months post-index procedure | Freedom from Fracture (FFF) at 12- and 24-months post-index procedure. |
| Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | 12, 24, and 36 months Post Index Procedure | Primary Target Lesion Patency (TLP) - Sustained and Expanded - for Target Lesion Lengths \> 160 mm at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Ratio (PSR) values of \< 2.0, \<2.5, and \< 3.0. |
| Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm. | 12-, 24-, and 36-months post-index procedure | Freedom from Target Lesion Revascularization (TTR) and/or Target Vessel Revascularization (TRV) for Target Lesion Lengths \> 160 mm at 12-, 24- and 36-months post-index procedure. |
| Secondary Safety Endpoint: Freedom From Composite Adverse Events | 30-days and 12-, 24-, and 36-months post-index procedure | Secondary Safety (Freedom from Composite Adverse Events) is defined as freedom from death (excluding 30-days and 12-months post-index procedure), stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 30-days and 12-, 24-, and 36-months post-index procedure. |
| Number of Stents Deployed With Acute Technical Success | Intra-procedure | Acute technical success is defined as successful deployment of the stent to the intended location. |
| Number of Acute Lesion Success | Intra-procedure | Acute lesion success is defined as attainment of ≤ 30% residual stenosis of the target lesion using any percutaneous method and/or non-investigational device (i.e., post-dilatation) based on angiographic data. |
| Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm. | 12-months Post-Index Procedure | Primary Effectiveness (Device Success) of Target Lesion Lengths \> 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup. |
| Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure | 24- and 36-months post-index procedure | Sustained Freedom from Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24- and 36-months post-index procedure. |
| Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure | 30 days, 12-, 24-, and 36-months post-index procedure | Sustained hemodynamic success is defined as sustained improvement of Ankle-Brachial Index (ABI) from baseline value of ≥ 0.15 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated Target Lesion Revascularization (TLR) in surviving subjects. |
| Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure | 30-days and 12-, 24-, and 36-months post-index procedure | Sustained clinical success is defined as sustained cumulative improvement from baseline value of ≥ 1 category according to Rutherford et al.12 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated TLR in surviving subjects. |
| Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure | 24- and 36-months post-index procedure | Sustained Target Lesion Patency (TLP) was measured at 24- and 36-months post-index procedure corresponding to PSR \< 2.5. |
| Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure | 12, 24, and 36 months Post-Index Procedure | Expanded TLP was measured at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) \< 3.0. |
| Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure | 12, 24, and 36 Months Post-Index Procedure | Cumulative (primary-assisted and secondary) Target Lesion Patency (TLP) was measured at 12-, 24-, and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) \< 2.5, and PSR \< 3.0. |
| Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | 30-days, and 12-, 24-, and 36-months post-index procedure | The Walking Impairment Questionnaire (WIQ) evaluation scale values range from 0 to 100, with 0 meaning inability to complete the specific task and 100 representing no difficulty in completing the task. A higher score (mean) represents an improvement in walking abilities compared to baseline measure. The results below represent, for each item measured (pain, walking distance, walking speed, and stair climbing), the mean difference between the score observed at Baseline and those observed at 30-days, 12-, 24-, and 36-months post-index procedure. |
| Number of Procedures With Acute Success | Intra-procedure | Acute procedure success is defined as lesion success and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel). |
| Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure. | 12-months post-index procedure | Target Lesion Revascularization (TLR) is defined as the interval following the index procedure until the first revascularization procedure of the target lesion. Target Vessel Revascularization (TVR) is defined as the interval following the index procedure until the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel. |
Countries
United States
Participant flow
Recruitment details
First subject enrolled on February 9, 2011 and the final follow-up was completed on September 19, 2018.
Participants by arm
| Arm | Count |
|---|---|
| LifeStent Percutaneous trasluminal angioplasty (PTA) plus stenting with the LifeStent® Vascular Stent System
PTA followed by placement of LifeStent® Vascular Stent: PTA followed by placement of LifeStent® Vascular Stent | 173 |
| Total | 173 |
Baseline characteristics
| Characteristic | LifeStent |
|---|---|
| Age, Continuous | 70.2 Years STANDARD_DEVIATION 9.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Lesion Calcification Absent | 25 Lesions |
| Lesion Calcification Lesion Thrombus | 5 Lesions |
| Lesion Calcification Lesion Ulceration | 24 Lesions |
| Lesion Calcification Mild | 54 Lesions |
| Lesion Calcification Moderate | 68 Lesions |
| Lesion Calcification Severe | 40 Lesions |
| Lesion Location Distal 1/3 of Superficial femoral artery (SFA) | 80 Lesions |
| Lesion Location Mid 1/3 of Superficial femoral artery (SFA) | 69 Lesions |
| Lesion Location Proximal 1/3 of Superficial femoral Artery (SFA) | 32 Lesions |
| Lesion Location Unknown | 6 Lesions |
| Lesion Type Occlusion | 57 Lesion type |
| Lesion Type Restenosed | 6 Lesion type |
| Lesion Type Stenosed | 124 Lesion type |
| Number of Target Lesions per Subject 1 | 161 Participants |
| Number of Target Lesions per Subject 2 | 10 Participants |
| Number of Target Lesions per Subject 3 | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 138 Participants |
| Region of Enrollment United States | 173 participants |
| Rutherford Category 0: Asymptomatic | 0 Participants |
| Rutherford Category 1: Mild Claudication | 0 Participants |
| Rutherford Category 2: Moderate Claudication | 25 Participants |
| Rutherford Category 3: Severe Claudication | 114 Participants |
| Rutherford Category 4: Ischemic Rest Pain | 31 Participants |
| Rutherford Category 5: Minor Tissue Loss | 0 Participants |
| Rutherford Category 6: Major Tissue Loss | 1 Participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 93 Participants |
| Target Limb Left | 91 Participants |
| Target Limb Right | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 173 |
| other Total, other adverse events | 150 / 173 |
| serious Total, serious adverse events | 111 / 173 |
Outcome results
Primary
Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure
The primary effectiveness endpoint of the study, device success, collectively measured both acute and chronic effectiveness. Acute effectiveness is defined as successful delivery of the stent to the intended site with the post-deployment stent length being within 10% of the pre-deployment stent length. Chronic effectiveness is defined as Primary Target Lesion Patency (TLP) at 12-months post-index procedure, as measured by Duplex Ultrasound (DUS).
Time frame: At time of procedure (acute) and 12-months post-index procedure (Chronic)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure | Acute effectiveness | 0.990 Probability of effectiveness |
| Overall Study | Primary Effectiveness Endpoint: Primary Target Lesion Patency (TLP) at Time of Procedure and 12-Months Post-Index Procedure | Device success at 12-month | 0.727 Probability of effectiveness |
Primary
Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure.
Primary safety endpoint defined as freedom from occurrence of death at 30-days and 12-months post-index procedure.
Time frame: 30-days and 12-months
Population: One subject expired on day 22 post-index procedure due to pneumonia (total N = 173, as per Participant Flow). The event was unrelated to study device but possibly related to procedure as adjudicated by the Clinical Events Committee (CEC).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure. | 30-days Post Index Procedure | 0.994 Probability of Event Free |
| Overall Study | Primary Safety Endpoint: Freedom From Death at 30-days and 12-months Post-Index Procedure. | 12-Months Post Index Procedure | 0.951 Probability of Event Free |
Secondary
Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure
The Walking Impairment Questionnaire (WIQ) evaluation scale values range from 0 to 100, with 0 meaning inability to complete the specific task and 100 representing no difficulty in completing the task. A higher score (mean) represents an improvement in walking abilities compared to baseline measure. The results below represent, for each item measured (pain, walking distance, walking speed, and stair climbing), the mean difference between the score observed at Baseline and those observed at 30-days, 12-, 24-, and 36-months post-index procedure.
Time frame: 30-days, and 12-, 24-, and 36-months post-index procedure
Population: (n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Pain at 30-days Post-Index Procedure | 43.4 Score on a Scale | Standard Deviation 34.61 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Pain at 12-Months Post-Index Procedure | 30.8 Score on a Scale | Standard Deviation 39.59 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Pain at 24-Months Post-Index Procedure | 33.8 Score on a Scale | Standard Deviation 42.46 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Pain at 36-Months Post-Index Procedure | 30.7 Score on a Scale | Standard Deviation 40.24 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Walking Distance at 30-days Post-Index Procedure | 26.46 Score on a Scale | Standard Deviation 33.55 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Walking Distance at 12-Months Post-Index Procedure | 19.89 Score on a Scale | Standard Deviation 35.83 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Walking Distance at 24-Months Post-Index Procedure | 22.97 Score on a Scale | Standard Deviation 30.83 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Walking Distance at 36-Months Post-Index Procedure | 26.39 Score on a Scale | Standard Deviation 35.99 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Walking Speed at 30-days Post-Index Procedure | 18.09 Score on a Scale | Standard Deviation 24.51 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Walking Speed at 12-Months Post-Index Procedure | 13.39 Score on a Scale | Standard Deviation 27.23 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Walking Speed at 24-Months Post-Index Procedure | 14.64 Score on a Scale | Standard Deviation 23.37 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Walking Speed at 36-Months Post-Index Procedure | 13.19 Score on a Scale | Standard Deviation 27.33 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Stair Climbing at 30-days Post-Index Procedure | 22.19 Score on a Scale | Standard Deviation 34.37 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Stair Climbing at 12-Months Post-Index Procedure | 16.96 Score on a Scale | Standard Deviation 34.8 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Stair Climbing at 24-Months Post-Index Procedure | 16.96 Score on a Scale | Standard Deviation 34.81 |
| Overall Study | Change From Baseline in Walking Impairment Questionnaire (WIQ) Results at 30-Days and 12, 24 and 36-Months Post-Index Procedure | Stair Climbing at 36-Months Post-Index Procedure | 10.05 Score on a Scale | Standard Deviation 38.47 |
Secondary
Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure
Cumulative (primary-assisted and secondary) Target Lesion Patency (TLP) was measured at 12-, 24-, and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) \< 2.5, and PSR \< 3.0.
Time frame: 12, 24, and 36 Months Post-Index Procedure
Population: The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (12, 24 and 36 months). Therefore n=160 instead of N=173.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure | At 12-months (PSR < 2.5) | 0.920 Probability of Target Lesion Patency |
| Overall Study | Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure | At 24-months (PSR < 2.5) | 0.745 Probability of Target Lesion Patency |
| Overall Study | Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure | At 36-months (PSR < 2.5) | 0.717 Probability of Target Lesion Patency |
| Overall Study | Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure | At 12-months (PSR < 3.0) | 0.928 Probability of Target Lesion Patency |
| Overall Study | Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure | At 24-months (PSR < 3.0) | 0.784 Probability of Target Lesion Patency |
| Overall Study | Cumulative (Primary Assisted and Secondary) Target Lesion Patency (TLP) at 12, 24, and 36 Months Post-Index Procedure | At 36-months (PSR < 3.0) | 0.745 Probability of Target Lesion Patency |
Secondary
Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure
Expanded TLP was measured at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Velocity Ratio (PSR) \< 3.0.
Time frame: 12, 24, and 36 months Post-Index Procedure
Population: The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (12, 24 and 36 months). Therefore n=161 instead of N=173.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure | At 36-months (PSR < 3.0) | 0.470 Probability of Lesion Patency |
| Overall Study | Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure | At 12-months (PSR < 3.0) | 0.761 Probability of Lesion Patency |
| Overall Study | Expanded Target Lesion Patency (TLP) for Peak Systolic Velocity Ratio (PSR) < 3.0 at 12, 24, and 36 Months Post-Index Procedure | At 24-months (PSR < 3.0) | 0.523 Probability of Lesion Patency |
Secondary
Freedom From Fracture at 12 and 24-Months Post-Index Procedure
Freedom from Fracture (FFF) at 12- and 24-months post-index procedure.
Time frame: 12- and 24-months post-index procedure
Population: The results presented in this analysis include active patients that had available x-ray images appropriate for analysis by the core-lab at follow-up time (12 and 24 months). Therefore n=166 instead of N=173.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Freedom From Fracture at 12 and 24-Months Post-Index Procedure | 12-Months Post-Index Procedure | 0.928 Probability of Event Free |
| Overall Study | Freedom From Fracture at 12 and 24-Months Post-Index Procedure | 24-Months Post-Index Procedure | 0.699 Probability of Event Free |
Secondary
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm.
Freedom from Target Lesion Revascularization (TTR) and/or Target Vessel Revascularization (TRV) for Target Lesion Lengths \> 160 mm at 12-, 24- and 36-months post-index procedure.
Time frame: 12-, 24-, and 36-months post-index procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm. | 12-months post-index procedure | 0.696 Probability of Event Free |
| Overall Study | Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm. | 24-months post-index procedure | 0.696 Probability of Event Free |
| Overall Study | Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12, 24, and 36-Months Post-Index Procedure for Target Lesion Lengths > 160 mm. | 36-months post index procedure | 0.696 Probability of Event Free |
Secondary
Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure.
Target Lesion Revascularization (TLR) is defined as the interval following the index procedure until the first revascularization procedure of the target lesion. Target Vessel Revascularization (TVR) is defined as the interval following the index procedure until the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel.
Time frame: 12-months post-index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Freedom From Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 12-months Post-index Procedure. | 0.822 Probability of Event Free |
Secondary
Number of Acute Lesion Success
Acute lesion success is defined as attainment of ≤ 30% residual stenosis of the target lesion using any percutaneous method and/or non-investigational device (i.e., post-dilatation) based on angiographic data.
Time frame: Intra-procedure
Population: N=175 (lesions) differs from the baseline characteristics module that mentions 187 treated lesions due to availability of angiographic image that show less than, or equal to 30% residual stenosis post-dilatation, as evaluated by the independent core-lab at time of analysis.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Overall Study | Number of Acute Lesion Success | 152 Target lesions |
Secondary
Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure
Sustained clinical success is defined as sustained cumulative improvement from baseline value of ≥ 1 category according to Rutherford et al.12 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated TLR in surviving subjects.
Time frame: 30-days and 12-, 24-, and 36-months post-index procedure
Population: (n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study | Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure | 30-days Post Index Procedure | 142 Participants |
| Overall Study | Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure | 12-Months Post Index Procedure | 91 Participants |
| Overall Study | Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure | 24-Months Post-Index Procedure | 56 Participants |
| Overall Study | Number of Participants With Sustained Clinical Success at 30-Days, 12, 24, and 36- Months Post-Index Procedure | 36-Months Post-Index Procedure | 33 Participants |
Secondary
Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure
Sustained hemodynamic success is defined as sustained improvement of Ankle-Brachial Index (ABI) from baseline value of ≥ 0.15 at 30-days and 12-, 24-, and 36-months post-index procedure without the need for repeated Target Lesion Revascularization (TLR) in surviving subjects.
Time frame: 30 days, 12-, 24-, and 36-months post-index procedure
Population: The number of participants for each time period represents the evaluable subjects for this specific outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study | Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure | 30-Days Post Index Procedure | 64 Participants |
| Overall Study | Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure | 12-Months Post-Index Procedure | 32 Participants |
| Overall Study | Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure | 24-Months Post-Index Procedure | 17 Participants |
| Overall Study | Number of Participants With Sustained Hemodynamic Success at 30-days, 12-, 24-, and 36-Months Post Index Procedure | 36-Months Post-Index Procedure | 13 Participants |
Secondary
Number of Procedures With Acute Success
Acute procedure success is defined as lesion success and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel).
Time frame: Intra-procedure
Population: One patient died at day 22, therefore, in this analysis N=172 instead of N=173.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Overall Study | Number of Procedures With Acute Success | 149 Procedures |
Secondary
Number of Stents Deployed With Acute Technical Success
Acute technical success is defined as successful deployment of the stent to the intended location.
Time frame: Intra-procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Overall Study | Number of Stents Deployed With Acute Technical Success | 201 Stents |
Secondary
Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm.
Primary Effectiveness (Device Success) of Target Lesion Lengths \> 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.
Time frame: 12-months Post-Index Procedure
Population: Target lesions \>160mm = 18 participants, and Target lesions treated with 200mm LifeStent = 41 participants. Therefore N=59.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm. | Target Lesion Length > 160 at 12 months | 0.438 Probability Device Success |
| Overall Study | Primary Effectiveness: Device Success at 12-Months Post-Index Procedure for Target Lesion Lengths > 160 mm Compared to LifeStent 200 mm. | Target Lesion Length LifeStent 200 mm at 12 months | 0.600 Probability Device Success |
Secondary
Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm.
• Primary Safety (freedom from occurrence of death at 30-days and 12-months post-index procedure) of the Target Lesion Lengths \> 160 mm subgroup compared to the Target Lesions treated with the 200 mm LifeStent® subgroup.
Time frame: 30-days and 12-months Post -Index Procedure
Population: Target lesions \>160mm = 18 participants, and Target lesions treated with 200mm LifeStent = 41 participants. Therefore N=59.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm. | Target Lesion Length > 160 at 30-days | 1 Probability of Event Free |
| Overall Study | Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm. | Target Lesion Length > 160 at 12-months | 0.871 Probability of Event Free |
| Overall Study | Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm. | Target Lesion Length 200 mm at 30-days | 1.000 Probability of Event Free |
| Overall Study | Primary Safety: Freedom From Death at 30-days and 12-months Post-Index Procedure for Target Lesion Lengths >160 mm Compared With LifeStent 200 mm. | Target Lesion Length 200 mm at 12-months | 0.976 Probability of Event Free |
Secondary
Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure
Primary Target Lesion Patency (TLP) - Sustained and Expanded - for Target Lesion Lengths \> 160 mm at 12-, 24- and 36-months post-index procedure corresponding to Peak Systolic Ratio (PSR) values of \< 2.0, \<2.5, and \< 3.0.
Time frame: 12, 24, and 36 months Post Index Procedure
Population: Eighteen (18) patients were enrolled with lesions \>160mm, therefore N=18. However, 15 patients had available data for analysis at 12, 24 and 36 months, therefore n=15.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | At 12-months (PSR < 2.0) | 0.464 Probability of Event Free |
| Overall Study | Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | At 24-months (PSR < 2.0) | 0.155 Probability of Event Free |
| Overall Study | Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | At 36-months (PSR < 2.0) | 0.155 Probability of Event Free |
| Overall Study | Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | At 12-months (PSR < 2.5) | 0.464 Probability of Event Free |
| Overall Study | Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | At 24-months (PSR < 2.5) | 0.232 Probability of Event Free |
| Overall Study | Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | At 36-months (PSR < 2.5) | 0.232 Probability of Event Free |
| Overall Study | Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | At 12-months (PSR < 3.0) | 0.464 Probability of Event Free |
| Overall Study | Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | At 24-months (PSR < 3.0 | 0.232 Probability of Event Free |
| Overall Study | Primary Target Lesion Patency (TLP) for Lesions > 160 mm at 12, 24, and 36 Months Post-Index Procedure | At 36-months (PSR < 3.0) | 0.232 Probability of Event Free |
Secondary
Secondary Safety Endpoint: Freedom From Composite Adverse Events
Secondary Safety (Freedom from Composite Adverse Events) is defined as freedom from death (excluding 30-days and 12-months post-index procedure), stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, target limb major amputation, and thrombosis of target vessel at 30-days and 12-, 24-, and 36-months post-index procedure.
Time frame: 30-days and 12-, 24-, and 36-months post-index procedure
Population: (n) varies in relation to the number of evaluable subjects at 30 days, 12, 24, and 36 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Secondary Safety Endpoint: Freedom From Composite Adverse Events | 30-days Post Index Procedure | 0.994 Probability of Event Free |
| Overall Study | Secondary Safety Endpoint: Freedom From Composite Adverse Events | 12-Months Post Index Procedure | 0.988 Probability of Event Free |
| Overall Study | Secondary Safety Endpoint: Freedom From Composite Adverse Events | 24-Months Post-Index Procedure | 0.945 Probability of Event Free |
| Overall Study | Secondary Safety Endpoint: Freedom From Composite Adverse Events | 36-Months Post-Index Procedure | 0.901 Probability of Event Free |
Secondary
Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure
Sustained Freedom from Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24- and 36-months post-index procedure.
Time frame: 24- and 36-months post-index procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure | 24-Months Post-Index Procedure | 0.669 Probability of Freedom from TLR or TRV |
| Overall Study | Sustained Freedom From Target Lesion Reintervention (TLR) and/or Target Vessel Reintervention (TVR) at 24 and 36 Months Post-Index Procedure | 36-Months Post-Index Procedure (PSR < 2.5) | 0.631 Probability of Freedom from TLR or TRV |
Secondary
Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure
Sustained Target Lesion Patency (TLP) was measured at 24- and 36-months post-index procedure corresponding to PSR \< 2.5.
Time frame: 24- and 36-months post-index procedure
Population: The results presented in this analysis include active patients that had available ultrasound images appropriate for analysis by the independent core-lab at follow-up time (24 and 36 months). Therefore n=161 instead of N=173.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure | 24-Months Post-Index Procedure (PSR < 2.5) | 0.510 Probability of sustained lesion patency |
| Overall Study | Sustained Target Lesion Patency (TLP) at 24 and 36 Months Post-Index Procedure | 36-Months Post-Index Procedure (PSR < 2.5) | 0.457 Probability of sustained lesion patency |