Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT03517904
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2016-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antiplatelet Therapy for Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease (IVUS-DCB)
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2023-11
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:
* Prospective, randomized, controlled, multi-center study
* A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria.
* Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group.
* Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional
* All patients will be treated with drug-coated balloons (In.PACT Admiral) for femoropopliteal lesions.
* Bare metal self-expandable stents will be used in addition according to findings of IVUS or angiography such as severity of arterial dissection or residual stenosis.
* Patients will be followed clinically for 1 year after the procedure.
* Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
* A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria.
* Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group.
* Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional
* All patients will be treated with drug-coated balloons (In.PACT Admiral) for femoropopliteal lesions.
* Bare metal self-expandable stents will be used in addition according to findings of IVUS or angiography such as severity of arterial dissection or residual stenosis.
* Patients will be followed clinically for 1 year after the procedure.
* Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: