Clinical trial NCT03517904: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoropopliteal Artery Disease
Keywords: Femoropopliteal artery disease, drug-coated balloon, angioplasty, antiplatelet therapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 237
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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)

Primary outcomes:
measure: Procedures lesion stenosis degree
timeFrame: at 12 months
Secondary outcomes:
measure: Survival free from target vessel revascularization
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References: