Ignite Creation Date:
2024-05-06 @ 12:22 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01558505
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2012-03-17
Brief Title:
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
Sponsor:
Leonardo Bolognese MD
Organization:
Ospedale San Donato
Study Overview
Official Title:
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation the DEBATE-BTK Study
Status:
COMPLETED
Status Verified Date:
2013-01
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:
DEBATE-BTK
Brief Summary:
Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention PTA The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon PEB InPact Amphirion Invatec Brescia Italy versus non drug-eluting balloon NEB Amphirion deep Invatec Brescia Italy in diabetic patients with Critical Limb Ischemia CLI undergoing PTA of below-the-knee BTK vessels
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