Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459888
Status:
COMPLETED
Last Update Posted:
2010-07-05
First Post:
2007-04-12
Brief Title:
Cryoplasty CLIMB-registry
Sponsor:
Flanders Medical Research Program
Organization:
Flanders Medical Research Program
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLIMB
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None