MedTrace Logo

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

NCT07408674 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-02-13

No results posted yet for this study

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

Interventions

DEVICE

Angiolite Sirolimus-Eluting Stenting

Conventional Provisional Stenting

DEVICE

Essential Pro Paclitaxel Drug-Eluting Balloon

Drug-Coated Balloon

Sponsors & Collaborators

  • iVascular S.L.U.

    collaborator INDUSTRY

  • Rede Optimus Hospitalar SA

    lead NETWORK

Principal Investigators

  • Gábor Tóth, MD, PhD · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2029-04-30
Completion
2029-05-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07408674 on ClinicalTrials.gov