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Cryoplasty CLIMB-registry (CLIMB)

Primary Purpose

Critical Limb Ischemia, Peripheral Arterial Occlusive Disease

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
PolarCath Peripheral Dilatation System (Boston Scientific)
Sponsored by
Flanders Medical Research Program
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring CLI, Critical Limb Ischemia, Infrapopliteal, Cryoplasty

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imelda Hospital
  • AZ Sint-Blasius
  • ZOL Campus Sint-Jan
  • University Hospital

Outcomes

Primary Outcome Measures

Clinical patency

Secondary Outcome Measures

Technical success
angiographic outcomes for the subgroup of patients in which made available.
Primary patency rate
Limb-salvage rate
Serious adverse events
Clinical success (improvement of Rutherford classification)
Health Economics assessment

Full Information

First Posted
April 12, 2007
Last Updated
July 2, 2010
Sponsor
Flanders Medical Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT00459888
Brief Title
Cryoplasty CLIMB-registry
Acronym
CLIMB
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Flanders Medical Research Program

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Peripheral Arterial Occlusive Disease
Keywords
CLI, Critical Limb Ischemia, Infrapopliteal, Cryoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PolarCath Peripheral Dilatation System (Boston Scientific)
Primary Outcome Measure Information:
Title
Clinical patency
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical success
Time Frame
procedure
Title
angiographic outcomes for the subgroup of patients in which made available.
Time Frame
12 months
Title
Primary patency rate
Time Frame
12 months
Title
Limb-salvage rate
Time Frame
12 months
Title
Serious adverse events
Time Frame
12 months
Title
Clinical success (improvement of Rutherford classification)
Time Frame
12 months
Title
Health Economics assessment
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bosiers, MD
Organizational Affiliation
AZ Sint-Blasius, Dendermonde, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Vermassen, MD
Organizational Affiliation
University Hospital Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Sint-Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
ZOL Campus Sint-Jan
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
20354489
Citation
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.
Results Reference
derived
Links:
URL
http://www.fmrp.be
Description
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