COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease. (COMPETE-LM)

The COMPETE-LM Trial: A Physician-initiated Randomized Clinical Trial (RCT) Comparing Conventional Provisional Stenting With Drug-coated Balloon-enhanced Provisional Stenting for the Treatment of Complex Left Main (LM) Coronary Artery Disease.

Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial.

Participants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).

The study aims to compare the clinical outcomes of conventional provisional stenting (Angiolite in the main branch, with optional side branch stenting if compromised) versus DCB enhanced provisional stenting (Angiolite in the main branch plus Essential Pro in the side branch) in patients with complex left main bifurcation stenosis indicated to receive non-urgent percutaneous coronary intervention (PCI).

Target lesions, both main vessel and side branch, will be treated using iVascular devices, with patients randomized into two arms. In one arm, treatment will be performed exclusively with the Angiolite sirolimus-eluting stent (Angiolite, iVascular) in the main vessel, while in the other arm, the Angiolite will be used in the main vessel and the Essential Pro paclitaxel drug-eluting balloon (Essential Pro, iVascular) in the side branch. Non-target lesions may be treated with any commercially available devices according to their approved indications.

Study Overview

• Status: Not yet recruiting
• Conditions: Left Main Coronary Artery Stenosis; Coronary Bifurcation Stenosis; Complex Left Main Bifurcation Stenosis
• Intervention / Treatment: Device: Angiolite Sirolimus-Eluting Stenting; Device: Essential Pro Paclitaxel Drug-Eluting Balloon

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annelena Held, PhD, MSc; Phone Number: +49 157 86743867; Email: annelena.held@redeoptimus.com
• Study Contact Backup: Name: Melissa Munoz Beilis, MD; Phone Number: +49 176 720 75 997; Email: melissa.munoz@redeoptimus.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization.
2. Left main diameter ≤6.00 mm.
3. LAD and LCx diameter both >2.75 mm, evaluated by visual estimation.

Exclusion Criteria:

1. Subjects with ages 18 or below at the time of the procedure.
2. Female subjects who may be pregnant or breast-feeding at the time of the procedure.
3. Previous PCI of the left main bifurcation.
4. Chronic total occlusion of the LAD or LCx.
5. Trifurcating left main requiring treatment of the 3 branches.
6. LAD and LCx reference sizes are out of the sizing ranges of the used DES/DCB families.
7. In-stent restenosis as target lesion.
8. Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system.
9. ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease.
10. Cardiogenic shock.
11. Left ventricular ejection fraction below 35%.
12. Decision to use mechanical circulatory support for protected PCI.
13. Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation).
14. Associated significant valvular disease.
15. Renal insufficiency with glomerular filtration rate (GFR) < 20.
16. Life expectancy less than one year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Stenting; Angiolite, iVascular	Device: Angiolite Sirolimus-Eluting Stenting; Conventional Provisional Stenting; Other Names: Coronary Stent
Experimental: DBC-enhanced Stenting; Essential Pro, iVascular	Device: Essential Pro Paclitaxel Drug-Eluting Balloon; Drug-Coated Balloon; Other Names: DBC; Drug Eluting Balloon; Drug Enhanced Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiography-based late lumen loss	Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch)	12 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2. Late lumen loss	Late lumen loss at the level of proximal- and distal main branch (primarily stented branch)	at 12 months post procedure
Stent thrombosis rate	Stent thrombosis rate (acute, subacute, late) at 12 months.	at 12 months post procedure
Optical coherence tomography (OCT)-based minimal stent / lumen area	Optical coherence tomography (OCT)-based minimal stent / lumen area at the level of LM, LAD ostium and left circumflex (LCx) ostium at 12 months.	at 12 months post procedure
OCT-based area stenosis	OCT-based area stenosis at the level of LM, LAD ostium and LCx ostium	at 12 months post procedure
Acute lumen gain (2D)	Acute lumen gain based on 2D quantitative coronary angiography	at index procedure
Acute lumen gain (3D)	Acute lumen gain based on 3D quantitative coronary angiography	at index procedure
Acute functional result	Acute functional result in the LAD and in the LCx, defined by Murray law-based quantitative flow ratio (μQFR)	at index procedure
Functional result in the LAD and in the LCx	Functional result in the LAD and in the LCx, defined by μQFR	at 12 months post procedure
Delta μQFR in the LAD and in the LCx	Delta μQFR in the LAD and in the LCx between acute (index procedure) and 12 months follow-up	at index procedure and at12 months post procedure
Malposition rate	Malapposition rate by OCT	at 12 months post procedure
Underexpansion rate	Underexpansion rate by OCT	at 12 months post procedure
Diameter stenosis	Diameter stenosis based on quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium	at 12 months post procedure
Area stenosis	Area stenosis based on 3D quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium	at 12 months post procedure
Conversion rate	Conversion rate to double-stent technique	at index procedure
Procedure time	Duration of index procedure	at index procedure
Used contrast media	Used contrast media at index procedure	at index procedure
Radiation dose	Radiation dose at index procedure	at index procedure
Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure	Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure	at 6 months and 12 months pos procedure
Death	Death upon 12 months	from index procedure to 12 months post procedure
Myocardial Infarction	Myocardial Infarction upon 12 months.	from index procedure to 12 months post procedure
Target vessel revascularization	Target vessel revascularization upon 12 months.	from index procedure to 12 months post procedure
Hospitalization for heart failure	Hospitalization for heart failure upon 12 months.	from index procedure to 12 months post procedure

Collaborators and Investigators

• Sponsor: Rede Optimus Hospitalar SA
• Collaborators: iVascular S.L.U.
• Investigators: Principal Investigator: Gábor Tóth, MD, PhD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Coronary Disease; Drug Coated Balloon; Drug Eluting Balloon; Left Main Coronary Artery; Essential Pro Paclitaxel; Angiolite; Left Main Artery; Left Main Coronary Artery Stenosis; Left Main Bifurcation Stenosis; Complex Left Main Disease; Provisional Stenting; Sirolimus Eluting Stent
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Coronary Artery Disease; Coronary Disease
• Other Study ID Numbers: RO-20250814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No