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

Abbott Medical Devices

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Peripheral Vascular Disease

Interventions

IDEV SUPERA StentDEVICE

Percutaneous Transluminal AngioplastyDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Primary patency

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

Time frame: 12 months

Secondary Outcomes

MAE-free survival rate.

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

Time frame: 12 months

Data from ClinicalTrials.gov

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