NCT00933270

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	SUPERA® Nitinol Stent System	Percutaneous Angioplasty of the Superior Femoral Artery with placement of a SUPERA® Stent at time of PTA

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2009-07-07
• Last updated: 2017-05-30
• Results posted: 2015-03-25

Locations

49 sites across 1 country: United States