NCT00459888

Cryoplasty CLIMB-registry

CLIMB Prospective Multicenter Registry Evaluating the Use of the PolarCath Peripheral Dilatation System (Boston Scientific) in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia (Rutherford 4 and 5).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Limb Ischemia
• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
DEVICE	PolarCath Peripheral Dilatation System (Boston Scientific)

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-04-13
• Last updated: 2010-07-05

Locations

4 sites across 1 country: Belgium