DEFINITIVE AR Two Year Follow-up Extension Study

NCT ID: NCT02363894

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-06-30

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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT

Study Groups

Subjects enrolled in DEFINITIVE AR

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Thomas Zeller, MD

Role: PRINCIPAL_INVESTIGATOR

Universitats Herzzentrum Freiburg - Bad Krozingen, Germany

Prof. Gunnar Tepe, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Rosenheim Institut fur Diagnostische und Interventionelle Radiologie - Rosenheim, Germany

Other Identifiers

CP-1009

Identifier Type: -

Identifier Source: org_study_id