FindTrial
Sign In

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)

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002972
Enrollment
240
Registered
2018-07-03
Start date
2016-05-12
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : - IVUS-guided group Angioplasty using drug-coated balloons (In.PACT Admiral, Medtronic) based on findings of intravascular ultrasound - Angiography-guided group Angioplasty using

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age 19 years or older 2) Symptomatic peripheral artery disease: - Moderate or severe claudication (Rutherford category 2 or 3) - Critical limb ischemia (Rutherford category 4 or 5) 3) Femoropopliteal artery disease (stenosis > 50%) 4) ABI <0.9 5) Patients with signed informed consent

Exclusion criteria

Exclusion criteria: 1) Acute critical limb ischemia 2) Severe critical limb ischemia (Rutherford category 6) 3) Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents 4) Patients requiring oral anticoagulation using warfarin or NOAC 5) Age > 85 years 6) Severe hepatic dysfunction (> 3 times normal reference values) 7) Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis 8) LVEF < 40% or clinically overt congestive heart failure 9) Pregnant women or women with potential childbearing 10) Life expectancy <1 year due to comorbidity 11) Previous bypass surgery or stenting in the target femoropopliteal artery 12) Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Design outcomes

Primary

MeasureTime frame
Primary patency , Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography—

Secondary

MeasureTime frame
ankle-brachial index;Rutherford category;frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel;Salvage of Target vessel—

Countries

Korea, Republic of

Contacts

Public ContactYoung-Guk Ko

Yonsei University Health System, Severance Hospital

YGKO@yuhs.ac+82-2-2228-8451

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026