Cryoplasty CLIMB-registry (CLIMB)

July 2, 2010 updated by: Flanders Medical Research Program

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: PolarCath Peripheral Dilatation System (Boston Scientific)

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Bonheiden, Belgium, 2820
    - Imelda Hospital
  - Dendermonde, Belgium, 9200
    - AZ Sint-Blasius
  - Genk, Belgium, 3600
    - ZOL Campus Sint-Jan
  - Ghent, Belgium, 9000
    - University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical patency Time Frame: 12 months	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Flanders Medical Research Program

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)