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.
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.
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.
Parallel
Angiolite Sirolimus-Eluting Stenting
DeviceConventional Provisional Stenting
Essential Pro Paclitaxel Drug-Eluting Balloon
DeviceDrug-Coated Balloon
Angiography-based late lumen loss
Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch)
2. Late lumen loss
Late lumen loss at the level of proximal- and distal main branch (primarily stented branch)
Stent thrombosis rate
Stent thrombosis rate (acute, subacute, late) at 12 months.
Optical coherence tomography (OCT)-based minimal stent / lumen area
Optical coherence tomography (OCT)-based minimal stent / lumen area at the level of LM, LAD ostium and left circumflex (LCx) ostium at 12 months.
OCT-based area stenosis
OCT-based area stenosis at the level of LM, LAD ostium and LCx ostium
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Rede Optimus Hospitalar SA
Lead sponsor
iVascular S.L.U.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
