CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs (CONTINUUM)

Study Overview
=================
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.

Official Title
-----------------
CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs (CONTINUUM)

Conditions
-----------------
Superficial Femoral Artery Stenosis

Intervention / Treatment
-----------------
* Device: PTA followed by placement of LifeStent® Vascular Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Subject agrees to comply with the protocol-mandated follow-up procedures and visits. The subject is ≥ 21 years old. Male or female subjects; female subjects of childbearing potential must have a negative urine pregnancy test at the time of screening. The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category 2-4. The target lesion(s) has angiographic evidence of stenosis or restenosis ≥ 50% or occlusion (by visual estimate) and is amenable to PTA with stenting. The total target lesion(s) length must be ≤ 240 mm. 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: 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. The subject has claudication or critical limb ischemia described as Rutherford Category 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss. The subject has multiple stenoses or occlusions > 240 mm. The subject has a previous stent or stent graft located in the target vessel. 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. The subject has a known contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, tantalum or sensitivity. The subject has a known contraindication to contrast media that is not amenable to pretreatment with steroids or/and antihistamines. The subject has a known history of bleeding diatheses or coagulopathy. The subject has concomitant renal failure with a creatinine of > 2.5 mg/dL. The subject is currently on dialysis or receiving systemic immunosuppressive therapy. The subject has known concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus, septicemia or deep vein thrombosis at the time of the index procedure. 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. 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. The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath. 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). 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. The subject has undergone any non-iliac percutaneous intervention(s) < 7 days prior to the index procedure.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overall Study<br>PTA plus stenting with the LifeStent® Vascular Stent System | Device: PTA followed by placement of LifeStent® Vascular Stent<br>* PTA followed by placement of LifeStent® Vascular Stent<br>* Other names: LifeStent® Vascular Stent; LifeStent® XL Vascular Stent; LifeStent® SOLO(TM) Vascular Stent;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30-days and 12-months | 
| 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). | At time of procedure (acute) and 12-months post-index procedure (Chronic) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12-months post-index procedure | 
| 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. | 30-days and 12-months Post -Index Procedure | 
| 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. | 12-months Post-Index Procedure | 
| Freedom From Fracture at 12 and 24-Months Post-Index Procedure | Freedom from Fracture (FFF) at 12- and 24-months post-index procedure. | 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 | 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. | 12, 24, and 36 months Post Index Procedure | 
| 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. | 12-, 24-, and 36-months post-index procedure | 
| 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. | 30-days and 12-, 24-, and 36-months post-index procedure | 
| Number of Stents Deployed With Acute Technical Success | Acute technical success is defined as successful deployment of the stent to the intended location. | Intra-procedure | 
| 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. | Intra-procedure | 
| 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). | Intra-procedure | 
| 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. | 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 | 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. | 30 days, 12-, 24-, and 36-months post-index procedure | 
| 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. | 30-days and 12-, 24-, and 36-months post-index procedure | 
| 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. | 24- and 36-months post-index procedure | 
| 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. | 12, 24, and 36 months Post-Index Procedure | 
| 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. | 12, 24, and 36 Months Post-Index Procedure | 
| 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. | 30-days, and 12-, 24-, and 36-months post-index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SFA, Popliteal, Stent, infrainguinal, LifeStent, Peripheral, Arterial