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)

Femoropopliteal Artery Disease Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Femoropopliteal Artery Disease

• NCT number: NCT03517904
• Study type: Interventional
• Source: Yonsei University
• Status: Completed
• Phase: N/A
• Start date: May 12, 2016
• Completion date: October 31, 2023