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

Peripheral Vascular Disease Clinical Trial

Official title:
Comparison of the SUpera® PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00933270
Study type Interventional
Source IDev Technologies, Inc.
Contact
Status Completed
Phase Phase 3
Start date July 2009
Completion date July 2014
View Details
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