Who is sponsoring NCT03517904?

NCT03517904 is sponsored by Yonsei University.

What drugs are being tested in NCT03517904?

Interventions in NCT03517904: IVUS-guided angioplasty, Angiography-guided angioplasty.

What condition does NCT03517904 study?

NCT03517904 studies Femoropopliteal Artery Disease.

Is NCT03517904 still recruiting?

NCT03517904 is currently completed. Last updated 5 December 2023.

Last reviewed 2023-12-05 · How we verify

NCT03517904

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed NA Last updated 5 December 2023

What this trial tests

NA trial testing IVUS-guided angioplasty in Femoropopliteal Artery Disease in 237 participants. Completed in 31 October 2023.

Timeline

12 May 2016

Primary endpoint
31 October 2023

31 October 2023

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	237
Start date	12 May 2016
Primary completion	31 October 2023
Estimated completion	31 October 2023
Sites	1 location across South Korea

Drugs / interventions tested

IVUS-guided angioplasty
Angiography-guided angioplasty

Conditions studied

Femoropopliteal Artery Disease — all drugs for Femoropopliteal Artery Disease →

Sponsor

Yonsei University

Who can join

Adults 19 to 85, any sex, with Femoropopliteal Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Intravascular Ultrasound-Guided vs Angiography-Guided Drug-Coated Balloon Angioplasty in Patients With Complex Femoropopliteal Artery Disease.
Lee SJ, Kim TH, Lee JH, Ahn CM, et al · · 2025 · cited 5× · PMID 39846915 · DOI 10.1016/j.jcin.2024.10.052
Twenty-Four-Month Outcomes of Intravascular Ultrasound-Guided Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease.
Shin J, Ahn CM, Lee SJ, Lee SH, et al · · 2025 · PMID 40792582 · DOI 10.1161/jaha.125.041564

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03517904 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yonsei University
Last refreshed: 5 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03517904.

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