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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00459888
Other study ID # FMRP-001
Secondary ID
Status Completed
Phase Phase 4
First received April 12, 2007
Last updated July 2, 2010
Start date May 2007
Est. completion date May 2009

Study information

Verified date July 2010
Source Flanders Medical Research Program
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
PolarCath Peripheral Dilatation System (Boston Scientific)


Locations

Country Name City State
Belgium Imelda Hospital Bonheiden
Belgium AZ Sint-Blasius Dendermonde
Belgium ZOL Campus Sint-Jan Genk
Belgium University Hospital Ghent

Sponsors (1)

Lead Sponsor Collaborator
Flanders Medical Research Program

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical patency 12 months No
Secondary Technical success procedure No
Secondary angiographic outcomes for the subgroup of patients in which made available. 12 months No
Secondary Primary patency rate 12 months No
Secondary Limb-salvage rate 12 months No
Secondary Serious adverse events 12 months Yes
Secondary Clinical success (improvement of Rutherford classification) 12 months No
Secondary Health Economics assessment 12 months No
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