Coronary Heart Disease (CHD)KONG-FREEDOM-INCT07587099

Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I)

A study testing Drug-coated balloon, Single antiplatelet therapy (SAPT) and Dual antiplatelet therapy (DAPT) in people with Coronary Heart Disease (CHD), run by Gan Lijun at 14 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Heart Disease (CHD)
What is being tested?: Drug-coated balloon, Single antiplatelet therapy (SAPT) and Dual antiplatelet therapy (DAPT)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,170 participants
Where: 14 sitesChina
Study dates: 4 May 2026to 31 Dec 2030
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who successfully underwent percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) treatment without stent implantation are eligible for inclusion in this study if Male and female patients who meet the following criteria：
Age ≥ 18 years.
target lesion in vessels with diameter ≥2.0 and ≤4.5 mm (visual estimation).
the total target vessels ≤2 and a total of target lesions ≤2.
Total length of DCB used for target lesions <60 mm.
The subject's indication for PCI is chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS), include Silent Ischemia, stable angina (SA), unstable angina (UA), non-ST-segment elevation myocardial (NSTEMI), or ST-segment elevation acute myocardial infarction (STEMI) with onset >2 weeks.

Show all 12Show fewer

All lesions were successfully treated with a drug-eluting balloon during routine clinical practice, i.e., post-procedural angiographic visual diameter stenosis <30%.
At the operator's discretion, no flow-limiting angiographic complications requiring extension of dual antiplatelet therapy (DAPT)have occurred.
All PCI stages have been completed (if applicable), and no further PCI procedures are planned.
Inclusion criteria at the randomization visit within 24 hours post-index PCI:
At the time of the randomization visit (within 24 hours after successful drug-eluting balloon treatment during index PCI), the following criteria mustbe met:
The subject must have had an uneventful clinical course within 24 hours post-index PCI, i.e., no myocardial infarction,symptomatic restenosis, device-related thrombus formation, stroke, or any revascularization procedure (coronary or non-coronary)requiring extension of dual antiplatelet therapy.

Who cannot join

Patients will be ineligible if they meet any of the following criteria:
Stent implantation within 6 months prior to index percutaneous coronary intervention (PCI).
Treatment for in-stent thrombosis (IST) at the time of index PCI or within 6 months prior to it.
Treatment with a bioabsorbable stent at any time prior to index PCI.
Acute myocardial infarction with ST-segment elevation within the past two weeks.
True bifurcation lesions requiring treatment with two stents (Medina 1,1,1/1,0,1/0,1,1) with a branch vessel diameter≥2.5 mm (visual estimation).

Show all 19Show fewer

Chronic total occlusion of the target lesion (≥3 months).
Unprotected left main coronary artery.
Thrombus present in the target lesion (imaging/visual).
Total length of DCB used in the target lesion ≥60 mm.
Active bleeding requiring medical intervention (BARC ≥2) at the time of randomization.
Indications for long-term oral anticoagulation therapy.
Life expectancy of less than 1 year.
Known allergy or hypersensitivity to aspirin, clopidogrel, ticagrelor, or sirolimus.
Currently participating in another trial and has not yet reached the primary endpoint.
History of asthma induced by salicylates or substances with similar effects (particularly nonsteroidal anti-inflammatory drugs).
Pregnant or breastfeeding women.
Inability to understand and follow study-related instructions or to comply with the study protocol.
Inability to provide written informed consent

Trial locations and contacts

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

Yong Cao contact

+86-0537-2905210

caoyong0419@163.com

City, postcode or hospital

Sites recruiting now only

14 sites in 1 country

China14 sites, 14 recruiting

Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality
Guangyao Zhai, +86 18501308666, Drzhaiguangyao@163.com
Wei He, +86 13261694832, 14916765@qq.com
Not yet recruiting
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan
Not yet recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Xiling Zhang, +86 18003608232, xlzhangdr@163.com
Not yet recruiting
Heze Municipal Hospital
Heze, Shandong
Ning Ma, +86 19953030211, 48725826@qq.com
Yongqi Huang, +86 13105119792, 892722535@qq.com
Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong
Haitao Yuan, +86 13688638072, doctoryuanht@126.com
Xinran Cao, +86 15098912873, caoxinran_1010@126.com
Not yet recruiting
Shandong Provincial Third Hospital
Jinan, Shandong
Guo Zhou, + 86 15853166471, zhouguo321@126.com
Yanwei Wang, +86 18663735013, 827469067@qq.com
Not yet recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029
Lijun Gan, 13792336453@163.com
Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong
Mingting Liang, +86 17862536696, Lmting007@163.com
Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Not yet recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
Wei Xia, +86 18669710958, 18669710958@163.com
Lei Zhang, +86 17685506687, suwen-021@163.com
Not yet recruiting
Shanghai Fengxian District People's Hospital
Shanghai, Shanghai Municipality
Jiangwei Ma, +86 18616357007, Majiangwei2004@126.com
Qiong Zhang, +86 13918155548, qiongzyw@163.com
Not yet recruiting
Tai'an City Central Hospital
Tai’an, Shandong
Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Not yet recruiting
Zaozhuang Municipal Hospital
Zaozhuang, Shandong
Jun Yang, +86 18563231799, yang_js775@163.com
Yaqing Yang, +86 19863279581, 601806846@qq.com
Not yet recruiting

Other trials in China

About this study

Official title: An Investigator-initiated, Multicenter, Open-label, Randomized Controlled Non-inferiority Trial to Assess the Single vs. Dual Antiplatelet Therapy in the Chronic Coronary Syndrome (CCS) and Stable Acute Coronary Syndrome (S-ACS) Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (DCB)-Only Strategy (KONG-FREEDOM-I)

This investigator-initiated, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor compared to dual antiplatelet therapy (DAPT) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients undergoing percutaneous coronary intervention (PCI) with the latest generation rapamycin drug-coated balloon (DCB) without stent implantation. The study aims to assess rates of ischemic and bleeding adverse events.

Read the detailed description

The purpose of the KONG-FREEDOM-I study is to evaluate the efficacy and safety of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor after successful PCI with the Fireliums coronary rapamycin drug-eluting balloon without stent implantation in coronary artery disease in vessels with a diameter between 2.0 and 4.5 mm, compared to routine dual antiplatelet therapy (DAPT). Patients with chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) will be enrolled and randomized in this study.

Conditions: Coronary Heart Disease (CHD)
Being tested: Drug-coated balloon, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT)
Keywords: Coronary Heart Disease, Drug-Coated Balloon Angioplasty, P2Y12 Inhibitor Monotherapy, Non-Inferiority Clinical Trial
Medical subject headings: Coronary Disease

What participants receive

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

Drug-coated balloonDevice
Fireliums rapamycin eluting coronary balloon dilatation catheter is a rapid exchange catheter, it has a patented microcrystalline coating process to ensure rapid drug delivery to the blood vessel wall and achieve a long-lasting sustained release effect, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
Single antiplatelet therapy (SAPT)Drug
The antithrombotic regimen is single antiplatelet (P2Y12 inhibitor）therapy (SAPT). The Investigator will decide whether to use ticagrelor first; if ticagrelor is not the first-line recommended drug, then clopidogrel will be considered. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.
Dual antiplatelet therapy (DAPT)Drug
The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.

Study groups in NCT07587099
Study group	Role	What they receive
Single antiplatelet therapy	Experimental	Not described Receives: Device: Drug-coated balloon; Drug: Single antiplatelet therapy (SAPT)
Dual antiplatelet therapy	Active comparator	Not described Receives: Device: Drug-coated balloon; Drug: Dual antiplatelet therapy (DAPT)

What is being measured

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

Rate of Net Adverse Clinical Events (NACE) at 12 months after randomization
Noninferiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in stable and unstable acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) without stent implantation assessed by the rate of Net Adverse Clinical Events (NACE). NACE is defined as the composite of all-cause mortality, myocardial infarction, stroke, and bleeding events (defined as BARC grade 3 or 5) following successful PCI with DCB without stent implantation at 12 months after randomization.
Measured: 12 months after randomization

Secondary outcomes (3)

Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome)
Incidence of clinically relevant bleeding events classified as BARC grades 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) bleeding definition (scale range 0-5; higher scores indicate worse outcome) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients treated with single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) without stent implantation.
Measured: 1, 3, 6, 12 and 24 months after randomization
Patient-oriented composite endpoint (PoCE)
Composite of all-cause death, all myocardial infarctions (MIs), or any repeat revascularization.
Measured: 1, 3, 6, 12 and 24 months after randomization
Device-oriented Composite Endpoint (DoCE)
Composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CI-TLR)
Measured: 1, 3, 6, 12 and 24 months after randomization

Timeline

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

4 May 202631 Dec 2030

First posted14 May 2026
Study start4 May 2026
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Coronary Heart Disease (CHD)Studies 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: Prospective, multi-center, open-label, randomized controlled, noninferiority trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 2,170 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07587099
Sponsor's protocol ID: JYFY-CV-001
Acronym: KONG-FREEDOM-I
Status last verified: Aug 2026
First submitted: 8 May 2026
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Publications

Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, Feit F, Gore JM, Hillis LD, Lambrew CT, et al. Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial. Ann Intern Med. 1991 Aug 15;115(4):256-65. doi: 10.7326/0003-4819-115-4-256.
PubMed 1906692
Valgimigli M, Garcia-Garcia HM, Vrijens B, Vranckx P, McFadden EP, Costa F, Pieper K, Vock DM, Zhang M, Van Es GA, Tricoci P, Baber U, Steg G, Montalescot G, Angiolillo DJ, Serruys PW, Farb A, Windecker S, Kastrati A, Colombo A, Feres F, Juni P, Stone GW, Bhatt DL, Mehran R, Tijssen JGP. Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC). Eur Heart J. 2019 Jul 1;40(25):2070-2085. doi: 10.1093/eurheartj/ehy377.
PubMed 29992264
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
Sabatine MS, Morrow DA, Giugliano RP, Burton PB, Murphy SA, McCabe CH, Gibson CM, Braunwald E. Association of hemoglobin levels with clinical outcomes in acute coronary syndromes. Circulation. 2005 Apr 26;111(16):2042-9. doi: 10.1161/01.CIR.0000162477.70955.5F. Epub 2005 Apr 11.
PubMed 15824203
Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
PubMed 17982182
Rao SV, O'Grady K, Pieper KS, Granger CB, Newby LK, Van de Werf F, Mahaffey KW, Califf RM, Harrington RA. Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes. Am J Cardiol. 2005 Nov 1;96(9):1200-6. doi: 10.1016/j.amjcard.2005.06.056. Epub 2005 Sep 12.
PubMed 16253582
Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
PubMed 28183511
Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
PubMed 30571511
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. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
PubMed 29897428
Rasanen A, Karkkainen JM, Eranti A, Eranen J, Rissanen TT. Percutaneous coronary intervention with drug-coated balloon-only strategy combined with single antiplatelet treatment in patients at high bleeding risk: Single center experience of a novel concept. Catheter Cardiovasc Interv. 2023 Feb;101(3):569-578. doi: 10.1002/ccd.30558. Epub 2023 Jan 22.
PubMed 36682076
Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, Hsu JC, Kiam OT, Qiu C, Qian J, Ahmad WAW, Ali RM. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136-149. doi: 10.5603/CJ.a2019.0093. Epub 2019 Sep 30.
PubMed 31565793
Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Investigators. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. 2025 Mar 31;388:e082945. doi: 10.1136/bmj-2024-082945.
PubMed 40164448
Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
PubMed 30170854
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.
PubMed 33091360
Corballis NH, Wickramarachchi U, Vassiliou VS, Eccleshall SC. Duration of dual antiplatelet therapy in elective drug-coated balloon angioplasty. Catheter Cardiovasc Interv. 2020 Nov;96(5):1016-1020. doi: 10.1002/ccd.28632. Epub 2019 Dec 4.
PubMed 31797532

Interested in taking part?

Yong Cao

+86-0537-2905210

caoyong0419@163.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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigator-initiated, Multicenter, Open-label, Randomized Controlled Non-inferiority Trial to Assess the Single vs. Dual Antiplatelet Therapy in the Chronic Coronary Syndrome (CCS) and Stable Acute Coronary Syndrome (S-ACS) Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (DCB)-Only Strategy (KONG-FREEDOM-I)
ClinicalTrials.gov ID: NCT07587099
Acronym / sponsor ID: KONG-FREEDOM-I / JYFY-CV-001
Conditions: Coronary Heart Disease (CHD)
Keywords: Coronary Heart Disease, Drug-Coated Balloon Angioplasty, P2Y12 Inhibitor Monotherapy, Non-Inferiority Clinical Trial
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 2,170 participants (estimated)
Lead sponsor: Gan LijunUniversity, hospital or other
Study start: 4 May 2026 (actual)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 14 May 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Prospective, multi-center, open-label, randomized controlled, noninferiority trial

Arm	Type	Receives
Single antiplatelet therapy	Experimental	Device: Drug-coated balloon, Drug: Single antiplatelet therapy (SAPT)
Dual antiplatelet therapy	Active comparator	Device: Drug-coated balloon, Drug: Dual antiplatelet therapy (DAPT)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Subjects who successfully underwent percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) treatment without stent implantation are eligible for inclusion in this study if Male and female patients who meet the following criteria：
Age ≥ 18 years.
target lesion in vessels with diameter ≥2.0 and ≤4.5 mm (visual estimation).
the total target vessels ≤2 and a total of target lesions ≤2.
Total length of DCB used for target lesions <60 mm.

Key exclusion criteria (19 listed)

Stent implantation within 6 months prior to index percutaneous coronary intervention (PCI).
Treatment for in-stent thrombosis (IST) at the time of index PCI or within 6 months prior to it.
Treatment with a bioabsorbable stent at any time prior to index PCI.
Acute myocardial infarction with ST-segment elevation within the past two weeks.
True bifurcation lesions requiring treatment with two stents (Medina 1,1,1/1,0,1/0,1,1) with a branch vessel diameter≥2.5 mm (visual estimation).

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 balloonFireliums rapamycin eluting coronary balloon dilatation catheter is a rapid exchange catheter, it has a patented microcrystalline coating process to ensure rapid drug delivery to the blood vessel wall and achieve a long-lasting sustained release effect, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.	Device	Dual antiplatelet therapy, Single antiplatelet therapy
Single antiplatelet therapy (SAPT)The antithrombotic regimen is single antiplatelet (P2Y12 inhibitor）therapy (SAPT). The Investigator will decide whether to use ticagrelor first; if ticagrelor is not the first-line recommended drug, then clopidogrel will be considered. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.	Drug	Single antiplatelet therapy
Dual antiplatelet therapy (DAPT)The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.	Drug	Dual antiplatelet therapy

Primary outcome

Rate of Net Adverse Clinical Events (NACE) at 12 months after randomization
Time frame: 12 months after randomization
Noninferiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in stable and unstable acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) without stent implantation assessed by the rate of Net Adverse Clinical Events (NACE). NACE is defined as the composite of all-cause mortality, myocardial infarction, stroke, and bleeding events (defined as BARC grade 3 or 5) following successful PCI with DCB without stent implantation at 12 months after randomization.

3 secondary outcomes

Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome)
Time frame: 1, 3, 6, 12 and 24 months after randomization
Patient-oriented composite endpoint (PoCE)
Time frame: 1, 3, 6, 12 and 24 months after randomization
Device-oriented Composite Endpoint (DoCE)
Time frame: 1, 3, 6, 12 and 24 months after randomization

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 17 Aug 2026.
Results publication: PubMed 1906692Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, Feit F, Gore JM, Hillis LD, Lambrew CT, et al. Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial. Ann Intern Med. 1991 Aug 15;115(4):256-65. doi: 10.7326/0003-4819-115-4-256.
Results publication: PubMed 29992264Valgimigli M, Garcia-Garcia HM, Vrijens B, Vranckx P, McFadden EP, Costa F, Pieper K, Vock DM, Zhang M, Van Es GA, Tricoci P, Baber U, Steg G, Montalescot G, Angiolillo DJ, Serruys PW, Farb A, Windecker S, Kastrati A, Colombo A, Feres F, Juni P, Stone GW, Bhatt DL, Mehran R, Tijssen JGP. Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC). Eur Heart J. 2019 Jul 1;40(25):2070-2085. doi: 10.1093/eurheartj/ehy377.
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 15824203Sabatine MS, Morrow DA, Giugliano RP, Burton PB, Murphy SA, McCabe CH, Gibson CM, Braunwald E. Association of hemoglobin levels with clinical outcomes in acute coronary syndromes. Circulation. 2005 Apr 26;111(16):2042-9. doi: 10.1161/01.CIR.0000162477.70955.5F. Epub 2005 Apr 11.
Results publication: PubMed 17982182Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
Results publication: PubMed 16253582Rao SV, O'Grady K, Pieper KS, Granger CB, Newby LK, Van de Werf F, Mahaffey KW, Califf RM, Harrington RA. Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes. Am J Cardiol. 2005 Nov 1;96(9):1200-6. doi: 10.1016/j.amjcard.2005.06.056. Epub 2005 Sep 12.
Results publication: PubMed 28183511Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol. 2017 Feb 14;69(6):679-691. doi: 10.1016/j.jacc.2016.11.045.
Results publication: PubMed 30571511Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
Results publication: PubMed 29897428Garcia-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. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
Results publication: PubMed 36682076Rasanen A, Karkkainen JM, Eranti A, Eranen J, Rissanen TT. Percutaneous coronary intervention with drug-coated balloon-only strategy combined with single antiplatelet treatment in patients at high bleeding risk: Single center experience of a novel concept. Catheter Cardiovasc Interv. 2023 Feb;101(3):569-578. doi: 10.1002/ccd.30558. Epub 2023 Jan 22.
Results publication: PubMed 31565793Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, Hsu JC, Kiam OT, Qiu C, Qian J, Ahmad WAW, Ali RM. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136-149. doi: 10.5603/CJ.a2019.0093. Epub 2019 Sep 30.
Results publication: PubMed 40164448Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Investigators. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. 2025 Mar 31;388:e082945. doi: 10.1136/bmj-2024-082945.
Individual participant dataSharing planned: Yes. After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

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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.

Yong Cao contact

+86-0537-2905210

caoyong0419@163.com

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

Questions about this trial

What is this clinical trial studying?

A study testing Drug-coated balloon, Single antiplatelet therapy (SAPT) and Dual antiplatelet therapy (DAPT) in people with Coronary Heart Disease (CHD), run by Gan Lijun at 14 sites in China.

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 12 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. 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 Yong Cao (+86-0537-2905210, caoyong0419@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Net Adverse Clinical Events (NACE) at 12 months after randomization (time frame: 12 months after randomization). 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 NCT07587099, which also lists 28 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 17 Aug 2026.