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)

Not Applicable

Completed

• Conditions: Femoropopliteal Artery Disease
• Interventions: Procedure: Angiography-guided angioplasty; Procedure: IVUS-guided angioplasty

• Registration Number: NCT03517904
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-12
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-05-08
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Age 19 years or older

• Symptomatic peripheral artery disease:

  • Moderate or severe claudication (Rutherford category 2 or 3)
  • Critical limb ischemia (Rutherford category 4 or 5)

• Femoropopliteal artery disease (stenosis > 50%)

• ABI <0.9

• Patients with signed informed consent

Read More

Exclusion Criteria

• Acute critical limb ischemia
• Severe critical limb ischemia (Rutherford category 6)
• Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
• Patients requiring oral anticoagulation using warfarin or NOAC
• Age > 85 years
• Severe hepatic dysfunction (> 3 times normal reference values)
• Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
• LVEF < 40% or clinically overt congestive heart failure
• Pregnant women or women with potential childbearing
• Life expectancy <1 year due to comorbidity
• Previous bypass surgery or stenting in the target femoropopliteal artery
• Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angiography-guided group	Angiography-guided angioplasty	Angiography-guided intervention group
IVUS-guided group	IVUS-guided angioplasty	Intravascular ultrasound-guided intervention group

Primary Outcome Measures

Name	Time	Method
Procedures lesion stenosis degree	at 12 months	Absence of restenosis \>50% by Duplex ultrasound, CT angiography, or catheter-based angiography

Secondary Outcome Measures

Name	Time	Method
Survival free from target vessel revascularization	12 months	Survival free from repeat intervention or surgical treatment due to loss of patency at the target vessel

Trial Locations

Locations (1)

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of