Efficacy of the EPIC Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) Lesions — EPIC SFA BR

Superficial Femoral Artery Stenosis Clinical Trial

Official title:
EPIC SFA - Physician Initiated Trial Investigating the Efficacy of the EPICTM Nitinol Vascular Stent System (Boston Scientific) in Superficial Femoral Lesions: A Prospective, Multi-center Non- Randomized Study - Endoconsul 003

Status Completed

Clinical Trial Summary

This is a national, prospective, multi-center, non-randomized study to evaluate the long-term efficacy and integrity of the EPICTM Nitinol Vascular Stent System in Superficial Femoral Artery (SFA) lesions. A total of 100 patients will be included in approximately 10 sites. The study is designed to demonstrate the EPIC Nitinol Vascular Stent System is non- inferior to the published patency rates found in the literature. This non-inferiority will be established by proving that the true rate for the EPICTM Nitinol Vascular Stent System is higher than 82% minus a 10% delta.

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Atherosclerosis
Atherosclerosis of Femoral Artery
Superficial Femoral Artery Stenosis

Clinical Trial Details

NCT number	NCT01327950
Study type	Observational
Source	Endovascular Consultoria Limitada
Contact
Status	Completed
Phase	N/A
Start date	October 2010
Completion date	November 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03121430` - Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion	N/A
Completed	`NCT05451485` - VFI in Healthy Vessels
Not yet recruiting	`NCT04175197` - LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries
Withdrawn	`NCT05079906` - Assessment of Superficial Femoral Artery Lesions With FFR From the ACIST Navvus® Catheter	N/A
Recruiting	`NCT04971772` - SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
Recruiting	`NCT04461496` - Full Metall Jacket Multilevel Segment	N/A
Recruiting	`NCT04434586` - Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions	N/A
Recruiting	`NCT05291247` - Shockwave IVL + DES
Completed	`NCT01602159` - Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)	N/A
Terminated	`NCT00908947` - CONTINuous Infra-Inguinal Stenting Using the Bard® LifeStent® VascUlar Stent SysteMs ("CONTINUUM")	N/A
Recruiting	`NCT05132361` - SELUTION4SFA Trial	N/A
Completed	`NCT01336101` - Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent	N/A