NCT07408674Not yet recruiting
COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.
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.
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- First submitted
- 6 Feb 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- Rede Optimus Hospitalar SA
- Diseases
- Coronary artery disease
- NCT number
- NCT07408674
What you commit to
- Study type: Interventional
- Planned participants: 186
- From 1 Apr 2026 to the primary completion date, 30 Apr 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PCI of the left main bifurcation.
- Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system.
- Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation).
Other illness
- ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease.
- Associated significant valvular disease.
Lab values
- Left ventricular ejection fraction below 35%.
- Renal insufficiency with glomerular filtration rate (GFR) \< 20.
Age
- Subjects with ages 18 or below at the time of the procedure.
Other
- Female subjects who may be pregnant or breast-feeding at the time of the procedure.
- 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.
- Cardiogenic shock.
- Decision to use mechanical circulatory support for protected PCI.
- Life expectancy less than one year.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.