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Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery

NCT00933270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2017-05-30

Study results available
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Summary

This is a prospective, multicenter, non-randomized, single arm, pivotal trial.

The main objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of percutaneous transvenous angioplasty (PTA) alone.

Conditions

  • Peripheral Vascular Disease

Interventions

DEVICE

SUPERA® Nitinol Stent System

Percutaneous Angioplasty of the Superior Femoral Artery with placement of a SUPERA® Stent at time of PTA

Sponsors & Collaborators

  • Baim Institute for Clinical Research

    collaborator OTHER

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Carol Base, RN,MS · Abbott Medical Devices

  • Kenneth Rosenfield, MD · Massachusetts General Hospital

  • Lawrence Garcia, MD · Steward St. Elizabeth's Medical Center of Boston, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-05-31
Completion
2014-07-31

Countries

  • United States

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 NCT00933270 on ClinicalTrials.gov