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Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent

NCT01336101 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-04-24

No results posted yet for this study

Summary

The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in patients with superficial femoral/ popliteal artery disease.

100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time the stent will be placed, and follow-up visits at 6 and 12 months.

Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will be efficacious in patients with Superficial Femoro/Popliteal Artery disease.

Conditions

  • Peripheral Arterial Diseases
  • Superficial Femoral Artery Stenosis

Interventions

DEVICE

EPIC™ Self-Expanding Nitinol Vascular Stent

SFA/Popliteal Artery stenting

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Provascular GmbH

    lead OTHER

Principal Investigators

  • Dierk Scheinert · Park-Krankenhaus Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-09-30
Completion
2012-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336101 on ClinicalTrials.gov