DEFINITIVE AR Two Year Follow-up Extension Study
Completed
- Conditions
- Peripheral Arterial Disease
- Registration Number
- NCT02363894
- Lead Sponsor
- Medtronic Endovascular
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major Adverse Event Rate 2 years
- Secondary Outcome Measures
Name Time Method