Cryoplasty CLIMB-registry

This study has been completed.
Sponsor:
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
  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 April 21, 2014