Cryoplasty CLIMB-registry

Critical Limb Ischemia Clinical Trial

— CLIMB  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459888
• Other study ID #: FMRP-001
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2007
• Last updated: July 2, 2010
• Start date: May 2007
• Est. completion date: May 2009

Study information

• Verified date: July 2010
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Intervention

Device:
• PolarCath Peripheral Dilatation System (Boston Scientific)

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	AZ Sint-Blasius	Dendermonde
Belgium	ZOL Campus Sint-Jan	Genk
Belgium	University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical patency		12 months	No
Secondary	Technical success		procedure	No
Secondary	angiographic outcomes for the subgroup of patients in which made available.		12 months	No
Secondary	Primary patency rate		12 months	No
Secondary	Limb-salvage rate		12 months	No
Secondary	Serious adverse events		12 months	Yes
Secondary	Clinical success (improvement of Rutherford classification)		12 months	No
Secondary	Health Economics assessment		12 months	No

External Links

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