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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single antiplatelet therapy | Experimental |
| |
| Dual antiplatelet therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
Patients will be ineligible if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Cao | Contact | +86-0537-2905210 | caoyong0419@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Third Hospital | Not yet recruiting | Jinan | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36682076 | Result | 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. | |
| 31565793 |
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After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
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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Prospective, multi-center, open-label, randomized controlled, noninferiority trial
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Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
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| 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. |
|
| 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. | 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) | 1, 3, 6, 12 and 24 months after randomization |
| Affiliated Hospital of Jining Medical University | Recruiting | Jining | Shandong | 272029 | China |
|
| Qingdao Municipal Hospital | Not yet recruiting | Qingdao | Shandong | China |
|
| 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. |
| 40164448 | 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. |
| 30170854 | 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. |
| 33091360 | 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. |
| 31797532 | 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. |
| 33156965 | 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. |
| 32740442 | 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. |
| 30368735 | 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. |
| 38956941 | 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. |
| 27379610 | 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. |
| 22386286 | 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. |
| 39124787 | 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. |
| 40051028 | 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. |
| 27069105 | 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. |
| 39105679 | 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. |
| 36847902 | 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. |
| 39660933 | 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. |
| 40582348 | 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. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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