Coronary Artery DiseaseFLOW-DCBNCT07852689

Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies

A study testing Drug-coated balloon-based intervention and Drug-eluting stent-based intervention in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Korea University Guro Hospital at 4 sites in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Coronary Artery Disease, Percutaneous Coronary Intervention, Drug Coated Balloon
What is being tested?: Drug-coated balloon-based intervention and Drug-eluting stent-based intervention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 4 sitesSouth Korea
Study dates: 9 Nov 2026to 30 Sep 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.
Angiographic exclusion:
Target lesion in ISR (in-stent restenosis).
Target lesion in a bypass graft.

Show all 13Show fewer

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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dong Oh Kang, MD, PhD contact

82-2-2626-3184

gelly9@naver.com

Soohyung Park, MD, PhD contact

+82-2-2626-1108

shp503@naver.com

South Korea4 sites

Hanil General Hospital
Seoul, 01450
Ji Bak Kim, MD, PhD, +82-2-901-3114, dr3120@gmail.com
Korea University Anam Hospital
Seoul, 02841
Jung-Joon Cha, MD, PhD, +82-920-5445, jungjoon@kumc.or.kr
Hanyang University Seoul Hospital
Seoul, 04763
Woohyeun Kim, MD, PhD, +82-2-2290-8114, coincidence1@naver.com
Korea University Guro Hospital
Seoul, 08308
Dong Oh Kang, MD, PhD, +82-2-2626-3184, gelly9@naver.com
Soohyung Park, MD, PhD, shp503@naver.com

Other trials in South Korea

About this study

Official title: Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies (FLOW-DCB): A Multicenter, Prospective, Randomized Controlled, Non-inferiority Trial

The main questions are:

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.
Does the DCB-based strategy reduce the number and total length of stents implanted?
What cardiovascular events or medical problems, such as cardiovascular death, myocardial infarction, repeat coronary procedures, or bleeding, occur during follow-up?

Investigators will randomly assign 100 participants to one of two treatment strategies. In the DCB-based group, the lesion will first be prepared with a balloon. A DCB will be used if lesion preparation produces a suitable result; a DES may be implanted if needed to achieve a safe and adequate result. In the DES-only group, the lesion will be treated with a DES.

Participants will:

Receive treatment according to their assigned strategy.
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.
Be followed for cardiovascular events through 12 months after randomization.

Read the detailed description

Background and objective Drug-coated balloons (DCBs) deliver an antiproliferative drug to the vessel wall during balloon inflation without leaving a permanent metallic implant. Drug-eluting stents (DESs) provide a permanent metallic scaffold that releases an antiproliferative drug. A DCB-based strategy prioritizes DCB treatment after adequate lesion preparation while allowing DES implantation when the procedural result is unsuitable for DCB treatment. Whether this strategy preserves coronary physiological function at follow-up compared with routine DES implantation remains uncertain. The FLOW-DCB trial will test whether DCB-based percutaneous coronary intervention (PCI) is noninferior to DES-only PCI with respect to fractional flow reserve (FFR) measured distal to the target or culprit lesion at approximately 6 months.
Study design and population 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. The target or culprit lesion must be suitable for either strategy and have a reference vessel diameter of at least 2.25 mm. Randomization is web-based and stratified by center and clinical diagnosis at PCI (acute vs. chronic coronary syndrome).
Treatment strategies 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. In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice. Intravascular ultrasound or optical coherence tomography may be used in either group at the operator's discretion. Antiplatelet and other medical treatments will be individualized according to current practice, the actual procedure, and the participant's bleeding and ischemic risks.
Assessments and outcomes 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. A pressure-sensing wire will be placed distal to the treated lesion, and FFR will be recorded during maximal hyperemia. Proximal FFR and the pressure difference across the lesion (trans-lesion ΔFFR) will be recorded when feasible. Pressure drift will be checked at the end of measurement. FFR before or immediately after PCI may be obtained but is not mandatory. The primary endpoint is mean FFR distal to the target or culprit lesion at follow-up. Secondary physiological and angiographic outcomes include trans-lesion ΔFFR, quantitative coronary angiographic measures, and the total number and length of implanted stents. Exploratory analyses will assess the effect of follow-up timing and changes in FFR when a baseline measurement is available. 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. Clinical events and safety data will be reviewed by an independent committee.
Statistical considerations The noninferiority margin for the difference in mean distal FFR (DCB-based PCI minus DES-only PCI) is -0.05. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval for this difference exceeds -0.05 (one-sided alpha 0.025). The protocol targets at least 25 evaluable FFR measurements per group and randomizes 50 per group to account for unavailable follow-up measurements. The primary analysis will use available FFR measurements within the protocol-defined follow-up window, according to the randomized treatment group; per-protocol and exploratory as-treated analyses are planned. The trial is designed to assess physiological noninferiority and is not powered to establish differences in clinical events.

Conditions: Coronary Artery Disease, Percutaneous Coronary Intervention, Drug Coated Balloon, Drug Eluting Stents (DES), Fractional Flow Reserve, Coronary Physiology
Being tested: Drug-coated balloon-based intervention, Drug-eluting stent-based intervention
Keywords: drug coated balloon, drug-eluting stent, coronary artery disease, fractional flow reserve, percutaneous coronary intervention, FLOW-DCB
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug-coated balloon-based interventionDevice
Also called Paclitaxel-coated balloon-based intervention
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.
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.

Study groups in NCT07852689
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Drug-eluting stent-based intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (18)

Trans-lesion ΔFFR
Difference between FFR measured proximal and distal to the target or culprit lesion.
Measured: 6 months (±30 days; up to 9 months if necessary)
Intermediate-term pressure gain (exploratory)
Change in distal FFR from baseline to follow-up in patients with a preprocedural FFR measurement.
Measured: 6 months (±30 days; up to 9 months if necessary)
Overall stent burden
Between-group differences in the total number and length of implanted stents
Measured: Immediately after index procedure
Quantitative coronary angiography (QCA) measures
Between-group differences in minimum lumen diameter and percentage diameter stenosis of the target or culprit lesion
Measured: 6 months (±30 days; up to 9 months if necessary)
Physiological outcomes by follow-up timing (exploratory)
Distal FFR and trans-lesion ΔFFR at 6-7 versus 8-9 months.
Measured: 6-7 months vs. 8-9 months
Cardiovascular death
Number of participants who die from cardiovascular causes, including sudden cardiac death; death due to acute myocardial infarction, heart failure, or cardiogenic shock; other cardiovascular causes; and death of unknown cause without an undisputed noncardiovascular cause.
Measured: From randomization through 12 months
All-cause death
Number of participants who die from any cause during follow-up.
Measured: From randomization through 12 months
Target-Vessel Myocardial Infarction
Number of participants with myocardial infarction attributed to the target vessel treated during the index procedure. Myocardial infarction is adjudicated using the protocol criteria adapted from the Fourth Universal Definition of Myocardial Infarction.
Measured: From randomization through 12 months
Nonfatal Myocardial Infarction
Number of participants with myocardial infarction that does not result in death. Spontaneous and procedure-related myocardial infarctions are included when they meet the protocol criteria adapted from the Fourth Universal Definition of Myocardial Infarction.
Measured: From randomization through 12 months
Clinically Indicated Target-Lesion Revascularization
Number of participants undergoing repeat percutaneous coronary intervention of the target lesion or coronary bypass surgery for target-lesion disease when revascularization is clinically indicated. The protocol requires diameter stenosis of at least 50% by quantitative coronary angiography together with corresponding ischemia on functional testing, ischemic electrocardiographic changes at rest, typical ischemic symptoms, a positive invasive physiological test (FFR ≤0.80 or instantaneous wave-free ratio ≤0.89), or diameter stenosis of at least 70% even without another ischemic criterion.
Measured: From randomization through 12 months
Clinically Indicated Target-Vessel Revascularization
Number of participants undergoing repeat percutaneous coronary intervention or coronary bypass surgery involving any segment of the target vessel when revascularization is clinically indicated. Clinical indication is determined using the protocol criteria for angiographic stenosis and symptoms, electrocardiographic changes, functional testing, or invasive physiological testing.
Measured: From randomization through 12 months
Any Revascularization
Number of participants undergoing any coronary revascularization after the index procedure, including percutaneous coronary intervention or coronary bypass surgery in a target or nontarget vessel, regardless of whether the procedure is classified as clinically indicated.
Measured: From randomization through 12 months
Definite or Probable Lesion or Stent Thrombosis
Number of participants with definite or probable thrombosis involving the treated target lesion or an implanted stent. Stent thrombosis is classified according to Academic Research Consortium criteria. For an unstented drug-coated balloon-treated lesion, definite lesion thrombosis is angiographically confirmed thrombus at the treated site with evidence of acute ischemia, or pathologically confirmed thrombus. Probable lesion thrombosis is myocardial infarction associated with documented acute ischemia in the treated lesion's territory, without angiographic confirmation of thrombus or another obvious cause.
Measured: From randomization through 12 months
Cardiovascular Death or Target-Vessel Myocardial Infarction
Number of participants who experience cardiovascular death or myocardial infarction attributed to the target vessel, whichever occurs first. Components are defined according to the protocol criteria.
Measured: From randomization through 12 months
All-Cause Death or Nonfatal Myocardial Infarction
Number of participants who die from any cause or experience a nonfatal myocardial infarction, whichever occurs first. Myocardial infarction is defined according to the protocol criteria.
Measured: From randomization through 12 months
Target-Vessel Failure
Number of participants who experience cardiovascular death, target-vessel myocardial infarction, or clinically indicated target-vessel revascularization, whichever occurs first.
Measured: From randomization through 12 months
Target-Lesion Failure
Number of participants who experience cardiovascular death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization, whichever occurs first.
Measured: From randomization through 12 months
Clinically Relevant Bleeding
Number of participants with Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. These categories include overt bleeding requiring clinical evaluation or treatment (type 2), major bleeding (type 3), and probable or definite fatal bleeding (type 5), as defined in the protocol.
Measured: From randomization through 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 202630 Sep 2029

First posted1 Oct 2026
Study start9 Nov 2026 (estimated)
Primary completion30 Sep 2028 (estimated)
Study completion30 Sep 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07852689
Sponsor's protocol ID: FLOW-DCB_KUGH
Acronym: FLOW-DCB
Status last verified: Sep 2026
First submitted: 25 Sep 2026
Last updated: 1 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Deidentified individual participant data may be shared with qualified researchers upon reasonable request and after approval of a submitted research proposal by the principal investigator and/or study steering committee. Data sharing will be conducted in accordance with applicable ethical and regulatory requirements.

Publications

Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
PubMed 40014670
Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
PubMed 39210710
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.
PubMed 37471501
Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
PubMed 37622654
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.
PubMed 29891620
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.
PubMed 21670242
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.
PubMed 30165617
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.
PubMed 31126887
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.
PubMed 29785878
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.
PubMed 8637515
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.
PubMed 33387557
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.
PubMed 25349065
Kim S, Kang DO, Her A-Y, Song WH, Shin E-S. Drug-Coated Balloon-Based Percutaneous Coronary Intervention in De Novo Coronary Artery Disease and Tips for Procedural Success. J Cardiovasc Interv. 2024;3.
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.
PubMed 42290366
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.
PubMed 39236727

Interested in taking part?

Dong Oh Kang, MD, PhD

82-2-2626-3184

gelly9@naver.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies (FLOW-DCB): A Multicenter, Prospective, Randomized Controlled, Non-inferiority Trial
ClinicalTrials.gov ID: NCT07852689
Acronym / sponsor ID: FLOW-DCB / FLOW-DCB_KUGH
Conditions: Coronary Artery Disease, Percutaneous Coronary Intervention, Drug Coated Balloon, Drug Eluting Stents (DES), Fractional Flow Reserve, Coronary Physiology
Keywords: drug coated balloon, drug-eluting stent, coronary artery disease, fractional flow reserve, percutaneous coronary intervention, FLOW-DCB
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Korea University Guro HospitalUniversity, hospital or other
Collaborators: B. Braun Melsungen AG
Study start: 9 Nov 2026 (estimated)
Primary completion: 30 Sep 2028 (estimated)
Study completion: 30 Sep 2029 (estimated)
First posted: 1 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main questions are:

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.
Does the DCB-based strategy reduce the number and total length of stents implanted?
What cardiovascular events or medical problems, such as cardiovascular death, myocardial infarction, repeat coronary procedures, or bleeding, occur during follow-up?

Participants will:

Receive treatment according to their assigned strategy.
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.
Be followed for cardiovascular events through 12 months after randomization.

Detailed description

Background and objective Drug-coated balloons (DCBs) deliver an antiproliferative drug to the vessel wall during balloon inflation without leaving a permanent metallic implant. Drug-eluting stents (DESs) provide a permanent metallic scaffold that releases an antiproliferative drug. A DCB-based strategy prioritizes DCB treatment after adequate lesion preparation while allowing DES implantation when the procedural result is unsuitable for DCB treatment. Whether this strategy preserves coronary physiological function at follow-up compared with routine DES implantation remains uncertain. The FLOW-DCB trial will test whether DCB-based percutaneous coronary intervention (PCI) is noninferior to DES-only PCI with respect to fractional flow reserve (FFR) measured distal to the target or culprit lesion at approximately 6 months.
Study design and population 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. The target or culprit lesion must be suitable for either strategy and have a reference vessel diameter of at least 2.25 mm. Randomization is web-based and stratified by center and clinical diagnosis at PCI (acute vs. chronic coronary syndrome).
Treatment strategies 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. In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice. Intravascular ultrasound or optical coherence tomography may be used in either group at the operator's discretion. Antiplatelet and other medical treatments will be individualized according to current practice, the actual procedure, and the participant's bleeding and ischemic risks.
Assessments and outcomes 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. A pressure-sensing wire will be placed distal to the treated lesion, and FFR will be recorded during maximal hyperemia. Proximal FFR and the pressure difference across the lesion (trans-lesion ΔFFR) will be recorded when feasible. Pressure drift will be checked at the end of measurement. FFR before or immediately after PCI may be obtained but is not mandatory. The primary endpoint is mean FFR distal to the target or culprit lesion at follow-up. Secondary physiological and angiographic outcomes include trans-lesion ΔFFR, quantitative coronary angiographic measures, and the total number and length of implanted stents. Exploratory analyses will assess the effect of follow-up timing and changes in FFR when a baseline measurement is available. 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. Clinical events and safety data will be reviewed by an independent committee.
Statistical considerations The noninferiority margin for the difference in mean distal FFR (DCB-based PCI minus DES-only PCI) is -0.05. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval for this difference exceeds -0.05 (one-sided alpha 0.025). The protocol targets at least 25 evaluable FFR measurements per group and randomizes 50 per group to account for unavailable follow-up measurements. The primary analysis will use available FFR measurements within the protocol-defined follow-up window, according to the randomized treatment group; per-protocol and exploratory as-treated analyses are planned. The trial is designed to assess physiological noninferiority and is not powered to establish differences in clinical events.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
DCB-based PCI group	Experimental	Device: Drug-coated balloon-based interventionIn 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.
DES-only PCI group	Active comparator	Device: Drug-eluting stent-based interventionIn the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (13 listed)

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.
Angiographic exclusion:
History of stent thrombosis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug-coated balloon-based interventionAlso: Paclitaxel-coated balloon-based interventionIn 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	DCB-based PCI group
Drug-eluting stent-based interventionIn the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice.	Device	DES-only PCI group

Primary outcome

Distal FFR at the target or culprit lesion
Time frame: 6 months (±30 days; up to 9 months if necessary)
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.

18 secondary outcomes

Trans-lesion ΔFFR
Time frame: 6 months (±30 days; up to 9 months if necessary)
Intermediate-term pressure gain (exploratory)
Time frame: 6 months (±30 days; up to 9 months if necessary)
Overall stent burden
Time frame: Immediately after index procedure
Quantitative coronary angiography (QCA) measures
Time frame: 6 months (±30 days; up to 9 months if necessary)
Physiological outcomes by follow-up timing (exploratory)
Time frame: 6-7 months vs. 8-9 months
Cardiovascular death
Time frame: From randomization through 12 months
All-cause death
Time frame: From randomization through 12 months
Target-Vessel Myocardial Infarction
Time frame: From randomization through 12 months
Nonfatal Myocardial Infarction
Time frame: From randomization through 12 months
Clinically Indicated Target-Lesion Revascularization
Time frame: From randomization through 12 months
Clinically Indicated Target-Vessel Revascularization
Time frame: From randomization through 12 months
Any Revascularization
Time frame: From randomization through 12 months
Definite or Probable Lesion or Stent Thrombosis
Time frame: From randomization through 12 months
Cardiovascular Death or Target-Vessel Myocardial Infarction
Time frame: From randomization through 12 months
All-Cause Death or Nonfatal Myocardial Infarction
Time frame: From randomization through 12 months
Target-Vessel Failure
Time frame: From randomization through 12 months
Target-Lesion Failure
Time frame: From randomization through 12 months
Clinically Relevant Bleeding
Time frame: From randomization through 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Results publication: PubMed 40014670Rao SV, O'Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, Baber U, Baker H, Cohen MG, Cruz-Ruiz M, Davis LL, de Lemos JA, DeWald TA, Elgendy IY, Feldman DN, Goyal A, Isiadinso I, Menon V, Morrow DA, Mukherjee D, Platz E, Promes SB, Sandner S, Sandoval Y, Schunder R, Shah B, Stopyra JP, Talbot AW, Taub PR, Williams MS. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. doi: 10.1161/CIR.0000000000001309. Epub 2025 Feb 27.
Results publication: PubMed 39210710Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.
Results publication: PubMed 37471501Virani 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.
Results publication: PubMed 37622654Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
Results publication: PubMed 29891620Garcia-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.
Results publication: PubMed 21670242Mehran 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.
Results publication: PubMed 30165617Thygesen 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.
Results publication: PubMed 31126887Vos 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.
Results publication: PubMed 29785878Xaplanteris 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.
Results publication: PubMed 8637515Pijls 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.
Results publication: PubMed 33387557Scheller 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.
Results publication: PubMed 25349065Kleber 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.
Individual participant dataSharing planned: Undecided. Deidentified individual participant data may be shared with qualified researchers upon reasonable request and after approval of a submitted research proposal by the principal investigator and/or study steering committee. Data sharing will be conducted in accordance with applicable ethical and regulatory requirements.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Dong Oh Kang, MD, PhD contact

82-2-2626-3184

gelly9@naver.com

Soohyung Park, MD, PhD contact

+82-2-2626-1108

shp503@naver.com

Dong Oh OK Kang, MD, PhD principal investigator

Cardiovascular Center, Korea University Guro Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong Oh Kang, MD, PhD (82-2-2626-3184, gelly9@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distal FFR at the target or culprit lesion (time frame: 6 months (±30 days; up to 9 months if necessary)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07852689, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.