Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Launched by CARITASKLINIK ST. THERESIA · Jul 21, 2014
Trial Information
Current as of May 13, 2025
Unknown status
Keywords
ClinConnect Summary
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).
Gender
ALL
Eligibility criteria
- 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
About Caritasklinik St. Theresia
Caritas-Klinik St. Theresia is a reputable healthcare institution dedicated to providing high-quality clinical care and advancing medical research. Located in [insert location], the clinic specializes in a range of therapeutic areas, focusing on patient-centered approaches and innovative treatment methodologies. As a clinical trial sponsor, Caritas-Klinik St. Theresia is committed to conducting ethically sound and scientifically rigorous research, aiming to enhance therapeutic options and improve patient outcomes. The clinic collaborates with multidisciplinary teams and adheres to stringent regulatory standards to ensure the safety and efficacy of its clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saarbrücken, Saarland, Germany
Patients applied
Trial Officials
Magnus Baumhäkel, MD
Principal Investigator
CaritasKlinikum, St. Theresia Saarbrücken, Germany
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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