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

NCT02198105 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2016-07-22

No results posted yet for this study

Summary

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Caritasklinik St. Theresia

    lead OTHER

Principal Investigators

  • Magnus Baumhäkel, MD · CaritasKlinikum, St. Theresia Saarbrücken, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02198105 on ClinicalTrials.gov