Skip to main content
OpenTrials
Completed

NCT Number: NCT00459888

Cryoplasty CLIMB-registry

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Arterial Occlusive Disease Peripheral Arterial Occlusive Disease 1 Peripheral Vascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Imelda Hospital, Bonheiden, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PolarCath Peripheral Dilatation System (Boston Scientific)

Device

Primary outcomes

  1. Clinical patency

    Time frame: 12 months

Secondary outcomes

  1. Technical success

    Time frame: procedure

  2. angiographic outcomes for the subgroup of patients in which made available.

    Time frame: 12 months

  3. Primary patency rate

    Time frame: 12 months

  4. Limb-salvage rate

    Time frame: 12 months

  5. Serious adverse events

    Time frame: 12 months

  6. Clinical success (improvement of Rutherford classification)

    Time frame: 12 months

  7. Health Economics assessment

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Flanders Medical Research Program

Network

Registry information

Official study 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).

Acronym: CLIMB

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 13, 2007
Registry last updated
Jul 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.