Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-04 @ 8:58 AM
Study NCT ID:
NCT02563535
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2015-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
Sponsor:
Ospedale San Donato
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2020-01
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:
ACOART-BTK
Brief Summary:
The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: