CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")
- Conditions
- Superficial Femoral Artery Stenosis
- Interventions
- Device: PTA followed by placement of LifeStent® Vascular Stent
- Registration Number
- NCT00908947
- Lead Sponsor
- C. R. Bard
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 173
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Overall Study PTA followed by placement of LifeStent® Vascular Stent PTA plus stenting with the LifeStent® Vascular Stent System
- Primary Outcome Measures
Name Time Method 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).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.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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 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.
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.
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 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.
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.
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.
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.
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.
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.
Trial Locations
- Locations (29)
University Surgical Associates, LLC
🇺🇸Chattanooga, Tennessee, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Loyola University Chicago
🇺🇸Chicago, Illinois, United States
Allegheny-Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Mission Cardiovascular Research Institute
🇺🇸Pleasanton, California, United States
South Florida Medical Imaging, PA
🇺🇸Fort Lauderdale, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Heartland Vascular Center
🇺🇸Joliet, Illinois, United States
Prairie Education and Research Cooperative (PERC)
🇺🇸Springfield, Illinois, United States
Cardiovascular Research of Northwest Indiana, LLC.
🇺🇸Munster, Indiana, United States
University of Kansas Medical Center Research Institute, Inc.
🇺🇸Kansas City, Kansas, United States
Kentucky Heart Foundation
🇺🇸Ashland, Kentucky, United States
Steward St. Elizabeth Medical Center of Boston Inc.
🇺🇸Boston, Massachusetts, United States
Midwest Aortic Vascular Institute P.C
🇺🇸North Kansas City, Missouri, United States
Metropolitan Hospital d/b/a Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
The Cooper Health System
🇺🇸Camden, New Jersey, United States
The Huntington Heart Center
🇺🇸Huntington, New York, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Saint Vincent Consultants in Cardiovascular Diseases, LLC
🇺🇸Erie, Pennsylvania, United States
Trustees of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
South Carolina Heart Center, P.A.
🇺🇸Columbia, South Carolina, United States
PinnacleHealth Cardiovascular Institute
🇺🇸Wormleysburg, Pennsylvania, United States
McLeod Regional Medical Center
🇺🇸Florence, South Carolina, United States
Sanford Research
🇺🇸Sioux Falls, South Dakota, United States
BCS Heart, LLP.
🇺🇸College Station, Texas, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Houston Center for Vascular Health
🇺🇸Houston, Texas, United States
The Methodist Hospital Research Institute dba Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
Aurora Medical Group
🇺🇸Milwaukee, Wisconsin, United States