We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Cryoplasty CLIMB-registry (CLIMB)

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.
ClinicalTrials.gov Identifier: NCT00459888
Recruitment Status : Completed
First Posted : April 13, 2007
Last Update Posted : July 5, 2010
Information provided by:

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  (Clinical Trial)
Estimated 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 2007
Primary Completion Date : May 2009
Study Completion Date : May 2009
Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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 Posted: April 13, 2007    Key Record Dates
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