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

Abbott

Status: Withdrawn

Conditions: Peripheral Vascular Disease

Treatments: Device: Percutaneous Transluminal Angioplasty; Device: IDEV SUPERA Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01667393

IDEV POP-01-US/OUS

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

IDEV SUPERA Stent

Experimental group

Description:

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

Treatment:

Device: IDEV SUPERA Stent

Percutaneous Transluminal Angioplasty

Active Comparator group

Description:

The target lesion will be treated by PTA alone.

Treatment:

Device: Percutaneous Transluminal Angioplasty