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Cryoplasty CLIMB-registry (CLIMB)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 13, 2007
Last Update Posted: July 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Flanders Medical Research Program
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
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).

Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • Clinical patency [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Technical success [ Time Frame: procedure ]
  • angiographic outcomes for the subgroup of patients in which made available. [ Time Frame: 12 months ]
  • Primary patency rate [ Time Frame: 12 months ]
  • Limb-salvage rate [ Time Frame: 12 months ]
  • Serious adverse events [ Time Frame: 12 months ]
  • Clinical success (improvement of Rutherford classification) [ Time Frame: 12 months ]
  • Health Economics assessment [ Time Frame: 12 months ]

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459888

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
Principal Investigator: Marc Bosiers, MD AZ Sint-Blasius, Dendermonde, Belgium
Principal Investigator: Frank Vermassen, MD University Hospital Ghent, Belgium
  More Information

Additional Information:
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
First Submitted: April 12, 2007
First Posted: April 13, 2007
Last Update Posted: July 5, 2010
Last Verified: July 2010

Keywords provided by Flanders Medical Research Program:
Critical Limb Ischemia

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases