Cryoplasty CLIMB-registry
Phase 4
Completed
- Conditions
- Critical Limb IschemiaPeripheral Arterial Occlusive Disease
- Registration Number
- NCT00459888
- Lead Sponsor
- Flanders Medical Research Program
- Brief Summary
In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected. The treatment occurs strictly according the "Instructions For Use" of the CE-approved device (PolarCath Peripheral Dilatation System, Boston Scientific) and only data are collected that have been made available conform the Standard the Standards of Care for these patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Symptomatic CLI male or female patients with at least 1 atherosclerotic diseased infrapopliteal artery. If patients present with more than 1 diseased vessel, only the vessel with the best distal run-off providing the foot with blood, will be assessed following treatment with the PolarCath Peripheral Dilatation System (Boston Scientific) and analysed for registry purposes.
Patients will be considered eligible for inclusion into the registry if satisfying the product DFU specifications.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical patency 12 months
- Secondary Outcome Measures
Name Time Method Technical success procedure angiographic outcomes for the subgroup of patients in which made available. 12 months Primary patency rate 12 months Limb-salvage rate 12 months Serious adverse events 12 months Clinical success (improvement of Rutherford classification) 12 months Health Economics assessment 12 months
Trial Locations
- Locations (4)
ZOL Campus Sint-Jan
🇧🇪Genk, Belgium
Imelda Hospital
🇧🇪Bonheiden, Belgium
AZ Sint-Blasius
🇧🇪Dendermonde, Belgium
University Hospital
🇧🇪Ghent, Belgium