Comparison of HYBRID Versus Two-Stent Strategies in Unprotected True Left MAIN Bifurcation

NCT07159737 | Not Yet Recruiting DMC

• 1 other identifier: 81117075727
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Unprotected Left Main Coronary Artery Disease

Keywords

drug-eluting stent; drug-coated balloon; unprotected left main coronary artery disease; hybrid strategy; two-stent strategy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Individual components of primary endpoint

  2 years

• Composite of cardiovascular death and TVMI

  2 years

• Safety endpoints

  2 years

Other Outcomes (3)

• Total procedure time

  Immediately after the procedure

• Contrast volume

  Immediately after the procedure

• Fluoroscopy dose

  Immediately after the procedure

Study Arms (2)

Two-stent strategy

ACTIVE COMPARATOR

Detailed technique is described in the Detailed study description paragraph

Procedure: Two-stent strategy

Hybrid strategy

EXPERIMENTAL

Detailed technique is described in the Detailed study description paragraph

Procedure: Hybrid Strategy

Interventions

Two-stent strategy PROCEDURE

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).

Two-stent strategy

Hybrid Strategy PROCEDURE

DES from LMCA to LAD and DCB to LCx. No LCx DES unless bail-out needed.

Hybrid strategy

Eligibility Criteria

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

You may qualify if:

• Floating eligibility criteria
• De novo unprotected true left main bifurcation (UTLMB) (Medina 1,1,1; 1,0,1; and 0,1,1).
• Optimal LCx lesion preparation (residual stenosis less than 30% with absence of flow-limiting dissection).
• The operator feels it might be appropriate to place either a drug-eluting stent (DES) or drug-coated balloon (DCB) to the LCX
• Clinically stable at the time of randomisation.
• Able to complete 2-year follow-up.
• Able to complete dual antiplatelet therapy (DAPT) as per guidelines.
• Written informed consent (or verbal consent on-table with written consent as soon as possible thereafter).

You may not qualify if:

• Protected left main (patent graft to LAD and LCX)
• Need for anticoagulation
• LCx reference vessel diameter less than 2.5 mm (\< 2.5 mm)
• Cardiogenic shock
• Severe left ventricular (LV) dysfunction making either strategy unsafe
• Contraindication to antiplatelet therapy or study devices
• Life expectancy less than 2 years
• Participation in another trial that may affect results

Sponsors & Collaborators

• Hospital Sultanah Bahiyah: lead
• Clinical Research Malaysia: collaborator

Related Publications (10)

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Study Officials

• Dharmaraj Karthikesan, M.D, MSc (Oxon)

  Hospital Sultanah Bahiyah, Alor Setar, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dharmaraj Karthikesan, M.D, MSc (Oxon)

CONTACT

+6047406524; dharmarajkarthikesan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Interventional Cardiologist

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share