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

NCT07408674 | Not Yet Recruiting DMC

• 1 other identifier: RO-20250814
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Complex Left Main Bifurcation Stenosis; Left Main Coronary Artery Stenosis; Coronary Bifurcation Stenosis

Keywords

Essential Pro Paclitaxel; Angiolite; Left Main Artery; Left Main Coronary Artery Stenosis; Left Main Coronary Artery; Left Main Bifurcation Stenosis; Coronary Disease; Coronary Artery Disease; Complex Left Main Disease; Drug Eluting Balloon; Drug Coated Balloon; Provisional Stenting; Sirolimus Eluting Stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• 2. Late lumen loss

  at 12 months post procedure

• Stent thrombosis rate

  at 12 months post procedure

• Optical coherence tomography (OCT)-based minimal stent / lumen area

  at 12 months post procedure

• OCT-based area stenosis

  at 12 months post procedure

• Acute lumen gain (2D)

  at index procedure

Study Arms (2)

Conventional Stenting

ACTIVE COMPARATOR

Angiolite, iVascular

Device: Angiolite Sirolimus-Eluting Stenting

DBC-enhanced Stenting

EXPERIMENTAL

Essential Pro, iVascular

Device: Essential Pro Paclitaxel Drug-Eluting Balloon

Interventions

Angiolite Sirolimus-Eluting Stenting DEVICE

Conventional Provisional Stenting

Also known as: Coronary Stent

Conventional Stenting

Essential Pro Paclitaxel Drug-Eluting Balloon DEVICE

Drug-Coated Balloon

Also known as: DBC, Drug Eluting Balloon, Drug Enhanced Balloon

DBC-enhanced Stenting

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rede Optimus Hospitalar SA: lead
• iVascular S.L.U.: collaborator

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Gábor Tóth, MD, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelena Held, PhD, MSc

CONTACT

+49 157 86743867; annelena.held@redeoptimus.com

Melissa Munoz Beilis, MD

CONTACT

+49 176 720 75 997; melissa.munoz@redeoptimus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share