Status:
COMPLETED
Cryoplasty CLIMB-registry
Lead Sponsor:
Flanders Medical Research Program
Conditions:
Critical Limb Ischemia
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
Phase:
PHASE4
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 "I...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00459888
Start Date
May 1 2007
End Date
May 1 2009
Last Update
July 5 2010
Active Locations (4)
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1
Imelda Hospital
Bonheiden, Belgium, 2820
2
AZ Sint-Blasius
Dendermonde, Belgium, 9200
3
ZOL Campus Sint-Jan
Genk, Belgium, 3600
4
University Hospital
Ghent, Belgium, 9000