Cryoplasty CLIMB-registry

Flanders Medical Research Program100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Critical Limb Ischemia Peripheral Arterial Occlusive Disease

Interventions

PolarCath Peripheral Dilatation System (Boston Scientific)DEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (4)

Imelda Hospital

Bonheiden, Belgium

AZ Sint-Blasius

Dendermonde, Belgium

ZOL Campus Sint-Jan

Genk, Belgium

University Hospital

Ghent, Belgium

Outcomes

Primary Outcomes

Clinical patency

Time frame: 12 months

Secondary Outcomes

Technical success

Time frame: procedure

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

Time frame: 12 months

Primary patency rate

Time frame: 12 months

Limb-salvage rate

Time frame: 12 months

Serious adverse events

Time frame: 12 months

Clinical success (improvement of Rutherford classification)

Time frame: 12 months

Health Economics assessment

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.