NCT07852689

Brief Summary

The goal of this clinical trial is to find out whether a treatment strategy based on a drug-coated balloon (DCB) achieves coronary artery function at 6 months that is not worse than a strategy using only drug-eluting stents (DES) by more than a prespecified amount. The study will enroll adults undergoing percutaneous coronary intervention (PCI) for a new coronary artery narrowing (de novo lesion). The main questions are:

  1. 1.Is fractional flow reserve (FFR) at 6 months noninferior after DCB-based PCI compared with DES-only PCI? FFR is a pressure-based measure used to assess blood flow through a coronary artery.
  2. 2.Does the DCB-based strategy reduce the number and total length of stents implanted?
  3. 3.What cardiovascular events or medical problems, such as cardiovascular death, myocardial infarction, repeat coronary procedures, or bleeding, occur during follow-up?
  4. 4.Receive treatment according to their assigned strategy.
  5. 5.Undergo follow-up coronary angiography and FFR measurement at approximately 6 months. For clinical reasons, this examination may take place up to 9 months after the procedure.
  6. 6.Be followed for cardiovascular events through 12 months after randomization.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
35mo left

Started Nov 2026

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 9, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

September 25, 2026

Last Update Submit

September 25, 2026

Conditions

Coronary Artery DiseasePercutaneous Coronary InterventionDrug Coated BalloonDrug Eluting Stents (DES)Fractional Flow ReserveCoronary Physiology

Keywords

drug coated balloondrug-eluting stentcoronary artery diseasefractional flow reservepercutaneous coronary interventionFLOW-DCB

Outcome Measures

Primary Outcomes (1)

  • Distal FFR at the target or culprit lesion

    Follow-up coronary angiography will be performed at 6 months (±30 days; up to 9 months if necessary), and distal FFR beyond the target or culprit lesion will be measured with a commercially available pressure wire as the primary outcome.

    6 months (±30 days; up to 9 months if necessary)

Secondary Outcomes (18)

  • Trans-lesion ΔFFR

    6 months (±30 days; up to 9 months if necessary)

  • Intermediate-term pressure gain (exploratory)

    6 months (±30 days; up to 9 months if necessary)

  • Overall stent burden

    Immediately after index procedure

  • Quantitative coronary angiography (QCA) measures

    6 months (±30 days; up to 9 months if necessary)

  • Physiological outcomes by follow-up timing (exploratory)

    6-7 months vs. 8-9 months

  • +13 more secondary outcomes

Study Arms (2)

DCB-based PCI group

EXPERIMENTAL

In the DCB-based PCI group, lesion preparation may include conventional, non-compliant, cutting, or scoring balloons and, when needed, other calcium-modification techniques. An adequately prepared lesion has expansion with a balloon-to-vessel diameter ratio of at least 0.90, residual diameter stenosis of 30% or less, TIMI grade 3 flow, and no flow-limiting dissection or risk of vessel closure. When these conditions are met, the operator will use a paclitaxel-coated DCB (SeQuent Please NEO), sized approximately 1:1 to the reference vessel and covering the prepared segment. DCB delivery within 30 seconds and inflation for 30-60 seconds are recommended when clinically tolerated. DES implantation is permitted for inadequate flow, residual stenosis greater than 30%, substantial recoil, a major dissection, or another procedural reason requiring immediate stenting. Such stenting is part of the assigned DCB-based strategy, not a treatment crossover.

Device: Drug-coated balloon-based intervention

DES-only PCI group

ACTIVE COMPARATOR

In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice.

Device: Drug-eluting stent-based intervention

Interventions

Drug-coated balloon-based interventionDEVICE

In the DCB-based PCI group, lesion preparation may include conventional, non-compliant, cutting, or scoring balloons and, when needed, other calcium-modification techniques. An adequately prepared lesion has expansion with a balloon-to-vessel diameter ratio of at least 0.90, residual diameter stenosis of 30% or less, TIMI grade 3 flow, and no flow-limiting dissection or risk of vessel closure. When these conditions are met, the operator will use a paclitaxel-coated DCB (SeQuent Please NEO), sized approximately 1:1 to the reference vessel and covering the prepared segment. DCB delivery within 30 seconds and inflation for 30-60 seconds are recommended when clinically tolerated. DES implantation is permitted for inadequate flow, residual stenosis greater than 30%, substantial recoil, a major dissection, or another procedural reason requiring immediate stenting. Such stenting is part of the assigned DCB-based strategy, not a treatment crossover.

Also known as: Paclitaxel-coated balloon-based intervention
DCB-based PCI group
Drug-eluting stent-based interventionDEVICE

In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice.

DES-only PCI group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 19 years or older.
  • Patients requiring coronary revascularization for angina or myocardial infarction.
  • A target or culprit lesion suitable for both DCB and DES treatment.
  • Reference vessel diameter of the target or culprit lesion ≥2.25 mm.
  • Voluntary written informed consent after an explanation of the study objectives and procedures.
  • For foreign nationals, ability to communicate in Korean.

You may not qualify if:

  • Active bleeding, a clinically significant bleeding tendency, or a coagulation disorder.
  • Hypersensitivity or a contraindication to aspirin, P2Y12 inhibitors, or components of a DES or DCB (drug, polymer, or metal).
  • Refractory cardiogenic shock.
  • Target lesion in ISR (in-stent restenosis).
  • Target lesion in a bypass graft.
  • Chronic total occlusion
  • Left main coronary artery disease.
  • History of stent thrombosis.
  • Expected survival of less than 1 year because of comorbid illness.
  • Left ventricular ejection fraction ≤20%.
  • Pregnancy or breastfeeding.
  • In the investigator's judgment, unsuitable for study participation for clinical or anatomical reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hanil General Hospital

Seoul, 01450, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Related Publications (20)

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    PMID: 39210710RESULT

  • Virani SS, Newby LK, Arnold SV, Bittner V, Brewer LC, Demeter SH, Dixon DL, Fearon WF, Hess B, Johnson HM, Kazi DS, Kolte D, Kumbhani DJ, LoFaso J, Mahtta D, Mark DB, Minissian M, Navar AM, Patel AR, Piano MR, Rodriguez F, Talbot AW, Taqueti VR, Thomas RJ, van Diepen S, Wiggins B, Williams MS; Peer Review Committee Members. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2023 Aug 29;148(9):e9-e119. doi: 10.1161/CIR.0000000000001168. Epub 2023 Jul 20.

    PMID: 37471501RESULT

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    PMID: 37622654RESULT

  • Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

    PMID: 29891620RESULT

  • Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

    PMID: 21670242RESULT

  • Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.

    PMID: 30165617RESULT

  • Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.

    PMID: 31126887RESULT

  • Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22.

    PMID: 29785878RESULT

  • Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.

    PMID: 8637515RESULT

  • Scheller B, Gemeinhardt O, Kleber FX. Late lumen enlargement after treatment of de-novo lesions with drug coated balloon catheters - Glagov effect or plaque regression? Int J Cardiol. 2021 Apr 15;329:79-81. doi: 10.1016/j.ijcard.2020.12.061. Epub 2020 Dec 30. No abstract available.

    PMID: 33387557RESULT

  • Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28.

    PMID: 25349065RESULT

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    RESULT

  • Spaulding C, Krackhardt F, Bogaerts K, Abdelaal E, Alfonso F, Briguori C, Bruch L, Cruden N, Den Hartog AW, Garot P, Godin M, Hildick-Smith D, Johnson T, Ladwiniec A, Linke A, Maart CA, Mashayekhi K, Meier P, Meunier L, Morgan K, O'Kane P, Puymirat E, Rissanen TT, Sabate M, Schmitz T, Toth GG, Trevelyan J, Wanczura P, Wiemer M, Wykrzykowska JJ, Urban P, Eccleshall S; SELUTION DeNovo Investigators. Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial. Circulation. 2026 Jul 21;154(3):185-197. doi: 10.1161/CIRCULATIONAHA.126.079033. Epub 2026 Jun 15.

    PMID: 42290366RESULT

  • Gao C, He X, Ouyang F, Zhang Z, Shen G, Wu M, Yang P, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Jiang H, Wen S, Liu Y, Li F, Zhou J, Zhu B, Liu Y, Zhang R, Zhang T, Wang P, Liu J, Jiang Z, Xia J, van Geuns RJ, Capodanno D, Garg S, Onuma Y, Wang D, Serruys PW, Tao L; REC-CAGEFREE I Investigators. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. 2024 Sep 14;404(10457):1040-1050. doi: 10.1016/S0140-6736(24)01594-0. Epub 2024 Sep 2.

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  • Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Wohrle J, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Osswald S, Cattaneo M, Gilgen N, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020 Nov 7;396(10261):1504-1510. doi: 10.1016/S0140-6736(20)32173-5. Epub 2020 Oct 19.

    PMID: 33091360RESULT

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    PMID: 36847902RESULT

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dong Oh OK Kang, MD, PhD

    Cardiovascular Center, Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Oh Kang, MD, PhD

CONTACT

82-2-2626-3184gelly9@naver.com

Soohyung Park, MD, PhD

CONTACT

+82-2-2626-1108shp503@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None of the parties are masked in this clinical trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: FLOW-DCB is an investigator-initiated, multicenter, prospective, randomized, parallel-group noninferiority trial conducted at four hospitals in the Republic of Korea. A total of 100 adults with angina or myocardial infarction requiring PCI for a de novo coronary lesion will be randomized 1:1 after diagnostic coronary angiography and before lesion preparation. 1. Group 1: DCB-based PCI group 2. Group 2: DES-only PCI group Follow-up coronary angiography and FFR measurement are planned at 6 months after randomization, with a ±30-day window; follow-up testing may be performed up to 9 months after the procedure for clinical reasons. Clinical events, including death, myocardial infarction, repeat coronary revascularization, lesion or stent thrombosis, and clinically relevant bleeding, will be assessed through 12 months after randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 1, 2026

Study Start (Estimated)

November 9, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2029

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations

KR(4)