Cryoplasty CLIMB-registry

Sponsor

Flanders Medical Research Program (Other)

Overall Status

Completed

CT.gov ID

NCT00459888

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Limb Ischemia Peripheral Arterial Occlusive Disease	Device: PolarCath Peripheral Dilatation System (Boston Scientific)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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).

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Outcome Measures

Primary Outcome Measures

Clinical patency [12 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.