Cryoplasty CLIMB-registry | NCT00459888

Studies
Cryoplasty CLIMB-registry

NCT00459888

Sponsor

Flanders Medical Research Program

Status

Completed

Last Update Posted

Jul 5, 2010Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Critical Limb Ischemia
Peripheral Arterial Occlusive Disease

Interventions

PolarCath Peripheral Dilatation System (Boston Scientific)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Apr 12, 2007

First Submission Date that Met QC Criteria

Apr 12, 2007

First Posted Date

Apr 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2010

Last Update Posted Date

Jul 5, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
PolarCath Peripheral Dilatation System (Boston Scientific)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical patency		12 months

Secondary Outcomes

Measure	Description	Time Frame
Technical success		procedure
angiographic outcomes for the subgroup of patients in which made available.		12 months
Primary patency rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Bosiers, MD	AZ Sint-Blasius, Dendermonde, Belgium	Principal Investigator
Frank Vermassen, MD	University Hospital Ghent, Belgium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imelda Hospital		Bonheiden		2820	Belgium
AZ Sint-Blasius

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20354489	Derived	Bosiers M, Deloose K, Vermassen F, Schroe H, Lauwers G, Lansinck W, Peeters P. The use of the cryoplasty technique in the treatment of infrapopliteal lesions for Critical Limb Ischemia patients in a routine hospital setting: one-year outcome of the Cryoplasty CLIMB Registry. J Cardiovasc Surg (Torino). 2010 Apr;51(2):193-202.

ID	Term
D000089802	Chronic Limb-Threatening Ischemia
C564658	Peripheral Arterial Occlusive Disease 1

ID	Term
D058729	Peripheral Arterial Disease
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases