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Clinical Trial 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").


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Superficial Femoral Artery Stenosis

NCT number NCT00908947
Study type Interventional
Source C. R. Bard
Contact
Status Terminated
Phase N/A
Start date February 2011
Completion date September 19, 2018

See also
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Recruiting NCT04461496 - Full Metall Jacket Multilevel Segment N/A
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Not yet recruiting NCT06410313 - First In Human Study to Assess Safety and Efficacy of the ChampioNIRâ„¢ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease N/A
Recruiting NCT05132361 - SELUTION4SFA Trial N/A
Completed NCT01336101 - Evaluation of Efficacy of the EPICâ„¢ Self-Expanding Nitinol Vascular Stent N/A
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A