Trials / Not Yet Recruiting
Not Yet RecruitingNCT07408674
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.
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- Sponsor
- Rede Optimus Hospitalar SA · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | Angiolite Sirolimus-Eluting Stenting | Conventional Provisional Stenting |
| DEVICE | Essential Pro Paclitaxel Drug-Eluting Balloon | Drug-Coated Balloon |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2029-04-01
- Completion
- 2029-05-01
- First posted
- 2026-02-13
- Last updated
- 2026-02-13
Source: ClinicalTrials.gov record NCT07408674. Inclusion in this directory is not an endorsement.