Popliteal Artery of Treatment With Balloon Angioplasty vs. SUPERA VERITAS Peripheral Stent System

Not Applicable

Withdrawn

• Conditions: Peripheral Vascular Disease
• Interventions: Device: Percutaneous Transluminal Angioplasty; Device: IDEV SUPERA Stent

• Registration Number: NCT01667393
• Lead Sponsor: Abbott Medical Devices

Brief Summary

Unblinded, randomized, balanced trial comparing 12 month target lesion patency rates of the IDEV SUPERA VERITAS peripheral stent system to PTA in the treatment of obstructive atherosclerotic popliteal artery disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Study Start: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subject has lifestyle limiting claudication or rest pain or at least a single de novo or restenotic popliteal artery lesion.

Exclusion Criteria

• Intervention distal to the target lesion is required at the time of the index procedure or within 30 days after the index procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous Transluminal Angioplasty	Percutaneous Transluminal Angioplasty	The target lesion will be treated by PTA alone.
IDEV SUPERA Stent	IDEV SUPERA Stent	Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.

Primary Outcome Measures

Name	Time	Method
Primary patency	12 months	Primary efficacy will be target lesion primary patency at 12 months.

Secondary Outcome Measures

Name	Time	Method
MAE-free survival rate.	12 months	Major Adverse Event-free survival rate that is non-inferior to that of PTA at 12 months.