Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion. (DEBTRAK)

July 21, 2016 updated by: Magnus Baumhäkel, Caritasklinik St. Theresia
Observational registry including patients with peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The registry includes consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).

Interventional procedure:

  1. PTA with Cutting-Balloon (60-120 seconds).
  2. PTA with Drug-Coated-Balloon (60 seconds).

Technical success is defined as

  1. no recoil >30%
  2. no dissection >Type B
  3. no stenting >30% of lesion length.

Follow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE, TLR, TVR, Binary Restenosis).

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Saarbrücken, Saarland, Germany, 66113
        • CaritasKlinikum, St. Theresia

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

Patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion.

Description

Inclusion Criteria:

  • peripheral artery disease (PAD) with femoro-popliteal stenosis >70% or occlusion (vessel diameter 4-6mm)
  • age 18-99
  • informed consent

Exclusion Criteria:

  • proximal / iliacal stenosis
  • stenosis/occlusion of all arteries below the knee

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Femoropopliteal stenosis

Consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion.

Intervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA.
Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA

Interventional procedure:

  1. PTA with Cutting-Balloon (60-120 seconds).
  2. PTA with DC-Balloon (60 seconds).

Technical success is defined as

  1. no recoil >30%
  2. no dissection >Type B
  3. no stenting >30% of lesion length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically driven target lesion revascularization (TLR)
Time Frame: 6 months
clinically driven target lesion revascularization
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinically driven target vessel revascularization (TVR)
Time Frame: 6 months
TVR
6 months
Binary restenosis
Time Frame: 6 months
Peak Systolic velocity (PSV) >2.4
6 months
Change in Ankle Brachial Index (ABI)
Time Frame: 6 months
Change in ankle brachial index from baseline.
6 months
Change in Rutherford-classification
Time Frame: 6 months
Change in Rutherford-Classification from Baseline (I-VI)
6 months
major cardiac adverse events
Time Frame: 6 months
myocardial infarction, stroke, death, cardiovascular death
6 months
Amputation
Time Frame: 6 months
6 months
clinically driven target vessel revascularization (TVR)
Time Frame: 12 months
12 months
Clinically driven target lesion revascularization (TLR)
Time Frame: 12 months
12 months
Binary restenosis
Time Frame: 12 months
12 months
Change in Ankle Brachial Index (ABI)
Time Frame: 12 months
12 months
Change in Rutherford-classification
Time Frame: 12 months
12 months
major cardiac adverse events
Time Frame: 12 months
myocardial infarction, stroke, death, cardiovascular death
12 months
Amputation
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Caritasklinik St. Theresia

Investigators

  • Principal Investigator: Magnus Baumhäkel, MD, CaritasKlinikum, St. Theresia Saarbrücken, 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

May 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEBTRAK-Registry

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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