Critical Limb Ischemia, Peripheral Arterial Occlusive Disease
Conditions
Keywords
CLI, Critical Limb Ischemia, Infrapopliteal, Cryoplasty
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.
Interventions
DEVICEPolarCath Peripheral Dilatation System (Boston Scientific)
Sponsors
Flanders Medical Research Program
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical patency | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| angiographic outcomes for the subgroup of patients in which made available. | 12 months |
| Primary patency rate | 12 months |
| Limb-salvage rate | 12 months |
| Technical success | procedure |
| Clinical success (improvement of Rutherford classification) | 12 months |
| Health Economics assessment | 12 months |
| Serious adverse events | 12 months |
Countries
Belgium
Outcome results
None listed