DEFINITIVE AR Two Year Follow-up Extension Study

Medtronic

Status: Completed

Conditions: Peripheral Arterial Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02363894

CP-1009

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

53 participants in 1 patient group

Subjects enrolled in DEFINITIVE AR