Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-04-22 @ 5:12 PM
Study NCT ID:
NCT02750605
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2016-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia
Sponsor:
Skane University Hospital
Organization:
Study Overview
Official Title:
Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries
Status:
COMPLETED
Status Verified Date:
2022-12
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:
None
Brief Summary:
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study
Results will be defined as:
Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.
Primary endpoints:
Primary Patency at 12 months, TLR (clinical driven),
Secondary endpoints:
Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,
Results will be defined as:
Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years.
Primary endpoints:
Primary Patency at 12 months, TLR (clinical driven),
Secondary endpoints:
Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,
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?: