Loading clinical trials...

CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM") | Clinical Trials | Clareo Health

TERMINATEDNA

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

NCT00908947•C. R. Bard

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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.
+7 more criteria

Locations (29)

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Mission Cardiovascular Research Institute

Pleasanton, California, United States

South Florida Medical Imaging, PA

Fort Lauderdale, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Loyola University Chicago

Chicago, Illinois, 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

Key Dates

Start Date

February 1, 2011

Primary Completion Date

September 18, 2018

Completion Date

September 19, 2018

Last Updated

November 19, 2019

Enrollment

173

ACTUAL participants

Conditions

Superficial Femoral Artery Stenosis

Interventions

PTA followed by placement of LifeStent® Vascular Stent

DEVICE

Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease

NCT07338890

Superficial Femoral Artery StenosisIliac Artery Stenosis+1 more

View study

COMPLETED

VFI in Healthy Vessels

NCT05451485

Carotid Artery StenosisSuperficial Femoral Artery Stenosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions