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

NCT07587099 | Recruiting DMC

• 1 other identifier: JYFY-CV-001
• Study Type: interventional
• Target: 2,170
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Coronary Heart Disease (CHD)

Keywords

Coronary Heart Disease; Drug-Coated Balloon Angioplasty; P2Y12 Inhibitor Monotherapy; Non-Inferiority Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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) patient 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, clinically driven target lesion revascularization (CD-TLR), and bleeding events (defined as BARC grade 3 or 5) following successful PCI with DCB without stent implantation at 12 months after randomization.

  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)

  1, 3, 6, 12 and 24 months after randomization

• Patient-oriented composite endpoint (PoCE)

  1, 3, 6, 12 and 24 months after randomization

• Device-oriented Composite Endpoint (DoCE)

  1, 3, 6, 12 and 24 months after randomization

Study Arms (2)

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)

Interventions

Drug-coated balloon DEVICE

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.

Dual antiplatelet therapy; Single antiplatelet therapy

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.

Single antiplatelet therapy

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.

Dual antiplatelet therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Gan Lijun: lead

Study Sites (3)

Shandong Provincial Third Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Affiliated Hospital of Jining Medical University

Jining, Shandong, 272029, China

RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, China

NOT YET RECRUITING

Related Publications (19)

• 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.

  PMID: 36682076 RESULT

• 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.

  PMID: 31565793 RESULT

• 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.

  PMID: 40164448 RESULT

• 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.

  PMID: 30170854 RESULT

• 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: 33091360 RESULT

• 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.

  PMID: 31797532 RESULT

• Musumeci G, Albani S. Drug-coated balloon angioplasty and 1 month DAPT strategy: Insights from the real world. Catheter Cardiovasc Interv. 2020 Nov;96(5):1021-1022. doi: 10.1002/ccd.29339. No abstract available.

  PMID: 33156965 RESULT

• Cortese B, Testa L, Di Palma G, Heang TM, Bossi I, Nuruddin AA, Ielasi A, Tespili M, Perez IS, Milazzo D, Benincasa S, Latib A, Cacucci M, Caiazzo G, Seresini G, Tomai F, Ocaranza R, Torres A, Perotto A, Bedogni F, Colombo A. Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry. J Cardiovasc Med (Hagerstown). 2021 Feb 1;22(2):94-100. doi: 10.2459/JCM.0000000000001070.

  PMID: 32740442 RESULT

• Mohiaddin H, Wong TDFK, Burke-Gaffney A, Bogle RG. Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review. Cardiol Ther. 2018 Dec;7(2):127-149. doi: 10.1007/s40119-018-0121-2. Epub 2018 Oct 27.

  PMID: 30368735 RESULT

• Her AY, Shin ES. Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives. Korean Circ J. 2024 Sep;54(9):519-533. doi: 10.4070/kcj.2024.0148. Epub 2024 Jun 3.

  PMID: 38956941 RESULT

• Poerner TC, Duderstadt C, Goebel B, Kretzschmar D, Figulla HR, Otto S. Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography. Clin Res Cardiol. 2017 Jan;106(1):18-27. doi: 10.1007/s00392-016-1019-4. Epub 2016 Jul 5.

  PMID: 27379610 RESULT

• Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012 Apr 10;59(15):1377-82. doi: 10.1016/j.jacc.2012.01.015. Epub 2012 Feb 29.

  PMID: 22386286 RESULT

• Corballis N, Bhalraam U, Merinopoulos I, Gunawardena T, Tsampasian V, Wickramarachchi U, Eccleshall S, Vassiliou VS. One-Month Duration Compared with Twelve-Month Duration of Dual Antiplatelet Therapy in Elective Angioplasty for Coronary Artery Disease: Bleeding and Ischaemic Outcomes. J Clin Med. 2024 Aug 2;13(15):4521. doi: 10.3390/jcm13154521.

  PMID: 39124787 RESULT

• Kawai K, Kolodgie FD, Kawakami R, Konishi T, Shiraki T, Sekimoto T, Tanaka T, Shen K, Virmani R, Finn AV. Vascular Response, Downstream Effect, and Pharmacokinetics After Sirolimus- and Paclitaxel-Coated Balloons in Porcine Coronary Arteries. Catheter Cardiovasc Interv. 2025 May;105(6):1434-1444. doi: 10.1002/ccd.31482. Epub 2025 Mar 6.

  PMID: 40051028 RESULT

• Clever YP, Peters D, Calisse J, Bettink S, Berg MC, Sperling C, Stoever M, Cremers B, Kelsch B, Bohm M, Speck U, Scheller B. Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model. Circ Cardiovasc Interv. 2016 Apr;9(4):e003543. doi: 10.1161/CIRCINTERVENTIONS.115.003543.

  PMID: 27069105 RESULT

• Cortese B, Malakouti S, Khater J, Munjal A. Magic Touch sirolimus-coated balloon: animal and clinical evidence of a coronary sirolimus drug-coated balloon. Future Cardiol. 2024;20(10):521-535. doi: 10.1080/14796678.2024.2345023. Epub 2024 Aug 6.

  PMID: 39105679 RESULT

• Muramatsu T, Kozuma K, Tanabe K, Morino Y, Ako J, Nakamura S, Yamaji K, Kohsaka S, Amano T, Kobayashi Y, Ikari Y, Kadota K, Nakamura M; Task Force of the Japanese Association of Cardiovascular Intervention, Therapeutics (CVIT). Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2023 Apr;38(2):166-176. doi: 10.1007/s12928-023-00921-2. Epub 2023 Feb 27.

  PMID: 36847902 RESULT

• Somsen YBO, Rissanen TT, Hoek R, Ris TH, Stuijfzand WJ, Nap A, Kleijn SA, Henriques JP, de Winter RW, Knaapen P. Application of Drug-Coated Balloons in Complex High Risk and Indicated Percutaneous Coronary Interventions. Catheter Cardiovasc Interv. 2025 Feb;105(2):494-516. doi: 10.1002/ccd.31316. Epub 2024 Dec 11.

  PMID: 39660933 RESULT

• Haq AU, Suhail A, Ahsan W, Maqbool H, Nawal A, Hassan H, Bungish MK, Shahid MA, Wazir HU, Yousaf H, Rehman MEU, Ahmad Cheema H, Alsubari AAAMA, Khan MA, Nadeem B, Ahmed R, Ahmad A. Efficacy of Drug-Coated Balloon versus Drug-Eluting Stent for Patients with De Novo Coronary Artery Disease: A Systematic Review and Meta-Analysis. Med Princ Pract. 2025;34(6):544-554. doi: 10.1159/000547099. Epub 2025 Jun 27.

  PMID: 40582348 RESULT

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Yong Cao

CONTACT

+86-0537-2905210; caoyong0419@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: Prospective, multi-center, open-label, randomized controlled, noninferiority trial

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
• Access Criteria: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Locations

CN (3)