DEFINITIVE AR Two Year Follow-up Extension Study

Medtronic Endovascular53 enrolled

Overview

The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Peripheral Arterial Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Was a subject in DEFINITIVE AR I * Is able and willing to provide written informated consent prior to study specific data collection. Exclusion Criteria: * Withdrew consent in DEFINITIVE AR I. * Was reported dead during DEFINITIVE AR I.

Outcomes

Primary Outcomes

Major Adverse Event Rate

Time frame: 2 years

Data from ClinicalTrials.gov

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