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

Starting soon · Not applicable

Conditions studied: Complex Left Main Bifurcation Stenosis, Left Main Coronary Artery Stenosis, Coronary Bifurcation Stenosis

In brief

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.

Key facts

Study ID

NCT07408674

Run by

Rede Optimus Hospitalar SA

People needed

186

Starts

2026-04-01

Expected to finish

2029-05-01

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Life expectancy less than one year.

Full record on ClinicalTrials.gov

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