DEFINITIVE AR Two Year Follow-up Extension Study

February 1, 2016 updated by: Medtronic Endovascular

Directional AthErectomy Followed by a PaclItaxel-Coated BalloN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment - Two Year Follow-up Extension Study

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

53

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who participated in DEFINITIVE AR I and completed the 12 month follow-up assessment in DEFINITIVE AR.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subjects enrolled in DEFINITIVE AR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major Adverse Event Rate
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Endovascular

Investigators

  • Principal Investigator: Prof. Thomas Zeller, MD, Universitats Herzzentrum Freiburg - Bad Krozingen, Germany
  • Principal Investigator: Prof. Gunnar Tepe, MD, Klinikum Rosenheim Institut fur Diagnostische und Interventionelle Radiologie - Rosenheim, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-1009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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