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

NCT ID: NCT01667393

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Peripheral Vascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IDEV SUPERA Stent

Following PTA of the target lesion, the SUPERA stent will be delivered to the treated segment.

Group Type: EXPERIMENTAL

IDEV SUPERA Stent

Intervention Type: DEVICE

Percutaneous Transluminal Angioplasty

The target lesion will be treated by PTA alone.

Group Type: ACTIVE_COMPARATOR

Percutaneous Transluminal Angioplasty

Intervention Type: DEVICE

Interventions

IDEV SUPERA Stent

Intervention Type: DEVICE

Percutaneous Transluminal Angioplasty

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IDEV POP-01-US/OUS

Identifier Type: -

Identifier Source: org_study_id