Cryoplasty CLIMB-registry
This study has been completed.
Sponsor:
Flanders Medical Research Program
Information provided by:
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT00459888
First received: April 12, 2007
Last updated: July 2, 2010
Last verified: July 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Critical Limb Ischemia Peripheral Arterial Occlusive Disease |
Device: PolarCath Peripheral Dilatation System (Boston Scientific) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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). |
Resource links provided by NLM:
Further study details as provided by Flanders Medical Research Program:
Primary Outcome Measures:
- Clinical patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Technical success [ Time Frame: procedure ] [ Designated as safety issue: No ]
- angiographic outcomes for the subgroup of patients in which made available. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Primary patency rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Limb-salvage rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Serious adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Clinical success (improvement of Rutherford classification) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Health Economics assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459888
Locations
| Belgium | |
| Imelda Hospital | |
| Bonheiden, Belgium, 2820 | |
| AZ Sint-Blasius | |
| Dendermonde, Belgium, 9200 | |
| ZOL Campus Sint-Jan | |
| Genk, Belgium, 3600 | |
| University Hospital | |
| Ghent, Belgium, 9000 | |
Sponsors and Collaborators
Flanders Medical Research Program
Investigators
| Principal Investigator: | Marc Bosiers, MD | AZ Sint-Blasius, Dendermonde, Belgium |
| Principal Investigator: | Frank Vermassen, MD | University Hospital Ghent, Belgium |
More Information
Additional Information:
No publications provided by Flanders Medical Research Program
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Flanders Medical Research Program (FMRP) |
| ClinicalTrials.gov Identifier: | NCT00459888 History of Changes |
| Other Study ID Numbers: | FMRP-001 |
| Study First Received: | April 12, 2007 |
| Last Updated: | July 2, 2010 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by Flanders Medical Research Program:
|
CLI Critical Limb Ischemia Infrapopliteal Cryoplasty |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Ischemia Peripheral Arterial Disease Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Atherosclerosis Arteriosclerosis Peripheral Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013