Cryoplasty CLIMB-registry
CLIMB
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).
1 other identifier
interventional
100
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2007
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2007
CompletedFirst Posted
Study publicly available on registry
April 13, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJuly 5, 2010
July 1, 2010
2 years
April 12, 2007
July 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical patency
12 months
Secondary Outcomes (7)
Technical success
procedure
angiographic outcomes for the subgroup of patients in which made available.
12 months
Primary patency rate
12 months
Limb-salvage rate
12 months
Serious adverse events
12 months
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Imelda Hospital
Bonheiden, 2820, Belgium
AZ Sint-Blasius
Dendermonde, 9200, Belgium
ZOL Campus Sint-Jan
Genk, 3600, Belgium
University Hospital
Ghent, 9000, Belgium
Related Publications (1)
Bosiers M, Deloose K, Vermassen F, Schroe H, Lauwers G, Lansinck W, Peeters P. The use of the cryoplasty technique in the treatment of infrapopliteal lesions for Critical Limb Ischemia patients in a routine hospital setting: one-year outcome of the Cryoplasty CLIMB Registry. J Cardiovasc Surg (Torino). 2010 Apr;51(2):193-202.
PMID: 20354489DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Bosiers, MD
AZ Sint-Blasius, Dendermonde, Belgium
- PRINCIPAL INVESTIGATOR
Frank Vermassen, MD
University Hospital Ghent, Belgium
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
April 12, 2007
First Posted
April 13, 2007
Study Start
May 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
July 5, 2010
Record last verified: 2010-07