Cryoplasty CLIMB-registry

Flanders Medical Research Program

Status and phase

Completed

Phase 4

Conditions

Peripheral Arterial Occlusive Disease

Critical Limb Ischemia

Treatments

Device: PolarCath Peripheral Dilatation System (Boston Scientific)

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00459888

FMRP-001

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.