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Clinical Trials/NCT00459888
NCT00459888CompletedPhase 4

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).

Flanders Medical Research Program8 sites in 1 country100 target enrollmentStarted: May 1, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
100
Locations
8
Primary Endpoint
Clinical patency
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Clinical patency

Time Frame: 12 months

Secondary Outcomes

  • 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)
  • Clinical success (improvement of Rutherford classification)(12 months)
  • Health Economics assessment(12 months)

Investigators

Sponsor Class
Network

Study Sites (8)

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