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Cryoplasty CLIMB-registry

NCT00459888 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-07-05

No results posted yet for this study

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.

Conditions

  • Critical Limb Ischemia
  • Peripheral Arterial Occlusive Disease

Interventions

DEVICE

PolarCath Peripheral Dilatation System (Boston Scientific)

Sponsors & Collaborators

  • Flanders Medical Research Program

    lead NETWORK

Principal Investigators

  • Marc Bosiers, MD · AZ Sint-Blasius, Dendermonde, Belgium

  • Frank Vermassen, MD · University Hospital Ghent, Belgium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00459888 on ClinicalTrials.gov