BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions
- Conditions
- Peripheral Artery Disease
- Registration Number
- NCT04830228
- Lead Sponsor
- Biotronik AG
- Brief Summary
BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions
- Detailed Description
Prospective, international, multi-center, single-arm study with up to 60 months follow up to evaluate safety and effectiveness of BIOTRONIK's Dynetic-35 stent associated with the use of Passeo-35 Xeo for the treatment of peripheral artery disease (PAD) in subjects with atherosclerotic disease in iliac arteries
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MAE at 12 months post-index procedure. 12 Months The MAE includes device or procedure related death within 30 days post index procedure, cdTLR, and major index limb amputation up to 12 months post index procedure.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
🇦🇹Graz, Austria
Zol Genk
🇧🇪Genk, Belgium
UZ Gent
🇧🇪Gent, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
🇧🇪Tienen, Belgium
Az Jan Potaels Vilvoorde
🇧🇪Vilvoorde, Belgium
Hôpital Privé du grand Narbonne
🇫🇷Narbonne, France
Hôpital Ambroise Paré
🇫🇷Paris, France
Klinikum Bayreuth
🇩🇪Bayreuth, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Diakonissenkrankenhaus
🇩🇪Flensburg, Germany
Scroll for more (5 remaining)LKH Univ.-Klinikum Graz, Ambulanz für Angiologie🇦🇹Graz, Austria