Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
NCT ID: NCT02198105
Last Updated: 2016-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2014-05-31
2016-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* age 18-99
* informed consent
Exclusion Criteria
* stenosis/occlusion of all arteries below the knee
18 Years
ALL
No
Sponsors
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Caritasklinik St. Theresia
OTHER
Responsible Party
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Magnus Baumhäkel
PD Dr. med. Magnus Baumhäkel
Principal Investigators
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Magnus Baumhäkel, MD
Role: PRINCIPAL_INVESTIGATOR
CaritasKlinikum, St. Theresia Saarbrücken, Germany
Locations
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CaritasKlinikum, St. Theresia
Saarbrücken, Saarland, Germany
Countries
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Other Identifiers
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DEBTRAK-Registry
Identifier Type: -
Identifier Source: org_study_id
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