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HYBRID MAIN
Comparison of Hybrid Versus Two-Stent Strategies in Patients With Unprotected True Left Main Coronary Artery Bifurcation Disease: A Streamlined, Multicentre, Investigator-Initiated, Randomized Superiority Trial (HYBRID MAIN)
Sponsor study identifier
interventional
800
0 countries
N/A
Study Start
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The number of deaths from heart disease is rising globally, particularly in developing countries. This condition involves the narrowing of arteries that supply blood to the heart. The most critical narrowing occurs in the left main coronary artery (LMCA), which supplies blood to over two-thirds of the heart muscle. Treating this narrowing is essential to prevent heart attacks or death. The LMCA divides into two branches, known as a bifurcation, both of which require treatment if narrowed. Currently, narrowing in both branches-the left anterior descending artery (LAD) and the left circumflex artery (LCx)-is treated with a two-stent strategy, where metallic stents are placed in each branch to keep the arteries open. However, this approach is prone to re-narrowing, particularly at the origin of the LCx. A new procedure, called the hybrid strategy, offers an alternative. It involves placing one stent in the LMCA and LAD while inflating a special balloon in the LCX. This balloon, known as a drug-coated balloon, releases a chemical that reduces narrowing over time without needing a stent. At present, there is uncertainty which strategy is better. This study will assess whether the hybrid strategy is more effective than the two-stent strategy in preventing death, heart attacks, and re-narrowing of the arteries. Participants will have an equal chance of receiving either the two-stent or hybrid strategy and will only join the study if their doctor is unsure which method is best. To minimise the burden on participants, all study procedures and follow-ups will be integrated into standard routine care. The results of this study have the potential to offer a new, safer treatment that could save the lives of millions of people with this condition.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2025
Actual (reported)September 8, 2025
Actual (reported)January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Target Lesion Failure (TLF)
Target lesion failure (TLF) at 2 years defined as a composite of: time to first event of cardiovascular death, time to first event of target vessel myocardial infarction (TVMI), time to first event of clinically driven target lesion revascularisation (CD-TLR).
2 years
Individual components of primary endpoint
2 years
Composite of cardiovascular death and TVMI
2 years
Safety endpoints
2 years
Total procedure time
Immediately after the procedure
Contrast volume
Immediately after the procedure
Fluoroscopy dose
Immediately after the procedure
Detailed technique is described in the Detailed study description paragraph
Detailed technique is described in the Detailed study description paragraph
DES from LMCA to LAD and DES to LCx using a recognised bifurcation technique such as double kissing crush (DK crush), Culotte, T-stenting or T and small protrusion (TAP).
DES from LMCA to LAD and DCB to LCx. No LCx DES unless bail-out needed.
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.
Vervoort D, Lee G, Lin Y, Contreras Reyes JR, Kanyepi K, Tapaua N. 6 Billion People Have No Access to Safe, Timely, and Affordable Cardiac Surgical Care. JACC Adv. 2022 Aug 26;1(3):100061. doi: 10.1016/j.jacadv.2022.100061. eCollection 2022 Aug. No abstract available.
Dharmaraj Karthikesan, M.D, MSc (Oxon)
Hospital Sultanah Bahiyah, Alor Setar, Malaysia
First Submitted
August 21, 2025
First Posted
September 8, 2025
Study Start
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Rathore S, Tehrani S, Prvulovic D, Araya M, Lefevre T, Banning AP, Burzotta F, Rigatelli G, Gutierrez-Chico JL, Bonaventura K, Chevalier B, Kinoshita Y, Sikic J, Alfonso F, Louvard Y, Stankovic G. Drug coated balloons and their role in bifurcation coronary angioplasty: appraisal of the current evidence and future directions. Expert Rev Med Devices. 2020 Oct;17(10):1021-1033. doi: 10.1080/17434440.2020.1831385. Epub 2020 Oct 14.
Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.
Chen X, Li X, Zhang JJ, Han Y, Kan J, Chen L, Qiu C, Santoso T, Paiboon C, Kwan TW, Sheiban I, Leon MB, Stone GW, Chen SL; DKCRUSH-V Investigators. 3-Year Outcomes of the DKCRUSH-V Trial Comparing DK Crush With Provisional Stenting for Left Main Bifurcation Lesions. JACC Cardiovasc Interv. 2019 Oct 14;12(19):1927-1937. doi: 10.1016/j.jcin.2019.04.056. Epub 2019 Sep 11.
Loh PH, Lassen JF, Jepson N, Koo BK, Chen S, Harding SA, Hu F, Lo S, Ahmad WAW, Ye F, Guagliumi G, Hiremath MS, Uemura S, Wang L, Whelan A, Low A. Asia Pacific consensus document on coronary bifurcation interventions. EuroIntervention. 2020 Oct 9;16(9):e706-e714. doi: 10.4244/EIJ-D-19-00977.
Zhang JJ, Ye F, Xu K, Kan J, Tao L, Santoso T, Munawar M, Tresukosol D, Li L, Sheiban I, Li F, Tian NL, Rodriguez AE, Paiboon C, Lavarra F, Lu S, Vichairuangthum K, Zeng H, Chen L, Zhang R, Ding S, Gao F, Jin Z, Hong L, Ma L, Wen S, Wu X, Yang S, Yin WH, Zhang J, Wang Y, Zheng Y, Zhou L, Zhou L, Zhu Y, Xu T, Wang X, Qu H, Tian Y, Lin S, Liu L, Lu Q, Li Q, Li B, Jiang Q, Han L, Gan G, Yu M, Pan D, Shang Z, Zhao Y, Liu Z, Yuan Y, Chen C, Stone GW, Han Y, Chen SL. Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial. Eur Heart J. 2020 Jul 14;41(27):2523-2536. doi: 10.1093/eurheartj/ehaa543.
Chen SL, Zhang JJ, Han Y, Kan J, Chen L, Qiu C, Jiang T, Tao L, Zeng H, Li L, Xia Y, Gao C, Santoso T, Paiboon C, Wang Y, Kwan TW, Ye F, Tian N, Liu Z, Lin S, Lu C, Wen S, Hong L, Zhang Q, Sheiban I, Xu Y, Wang L, Rab TS, Li Z, Cheng G, Cui L, Leon MB, Stone GW. Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial. J Am Coll Cardiol. 2017 Nov 28;70(21):2605-2617. doi: 10.1016/j.jacc.2017.09.1066. Epub 2017 Oct 30.
Hildick-Smith D, Egred M, Banning A, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefevre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. 2021 Oct 1;42(37):3829-3839. doi: 10.1093/eurheartj/ehab283.
Dabrowski EJ, Kozuch M, Dobrzycki S. Left Main Coronary Artery Disease-Current Management and Future Perspectives. J Clin Med. 2022 Sep 28;11(19):5745. doi: 10.3390/jcm11195745.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 30, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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