NCT00908947

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Superficial Femoral Artery Stenosis

Interventions

Type	Name	Description
DEVICE	PTA followed by placement of LifeStent® Vascular Stent	PTA followed by placement of LifeStent® Vascular Stent

Timeline

• Start date: 2011-02-01
• Primary completion: 2018-09-18
• Completion: 2018-09-19
• First posted: 2009-05-27
• Last updated: 2019-11-19
• Results posted: 2019-11-06

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated device study