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Not yet recruiting NCT07408674

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

No phase Interventional Complex Left Main Bifurcation Stenosis Left Main Coronary Artery Stenosis Coronary Bifurcation Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Angiolite Sirolimus-Eluting Stenting, Essential Pro Paclitaxel Drug-Eluting Balloon.
Who it may be relevant to
Registry conditions: Complex Left Main Bifurcation Stenosis, Left Main Coronary Artery Stenosis, Coronary Bifurcation Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • Device Angiolite Sirolimus-Eluting Stenting
    Conventional Provisional Stenting
  • Device Essential Pro Paclitaxel Drug-Eluting Balloon
    Drug-Coated Balloon

Primary outcome measures

  • Angiography-based late lumen loss [Time frame: 12 months post procedure]
Secondary outcome measures (12)
  • 2. Late lumen loss [Time frame: at 12 months post procedure]
  • Stent thrombosis rate [Time frame: at 12 months post procedure]
  • Optical coherence tomography (OCT)-based minimal stent / lumen area [Time frame: at 12 months post procedure]
  • OCT-based area stenosis [Time frame: at 12 months post procedure]
  • Acute lumen gain (2D) [Time frame: at index procedure]
  • Acute lumen gain (3D) [Time frame: at index procedure]
  • Acute functional result [Time frame: at index procedure]
  • Functional result in the LAD and in the LCx [Time frame: at 12 months post procedure]
  • Delta μQFR in the LAD and in the LCx [Time frame: at index procedure and at12 months post procedure]
  • Malposition rate [Time frame: at 12 months post procedure]
  • Underexpansion rate [Time frame: at 12 months post procedure]
  • Diameter stenosis [Time frame: at 12 months post procedure]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07408674 · RO-20250814

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗