Complex Left Main Bifurcation Stenosis, Coronary Bifurcation Stenosis, Left Main Coronary Artery Stenosis
Conditions
Keywords
Essential Pro Paclitaxel, Angiolite, Left Main Artery, Left Main Coronary Artery Stenosis, Left Main Coronary Artery, Left Main Bifurcation Stenosis, Coronary Disease, Coronary Artery Disease, Complex Left Main Disease, Drug Eluting Balloon, Drug Coated Balloon, Provisional Stenting, Sirolimus Eluting Stent
Brief 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.
Interventions
DEVICEAngiolite Sirolimus-Eluting Stenting
Conventional Provisional Stenting
DEVICEEssential Pro Paclitaxel Drug-Eluting Balloon
Drug-Coated Balloon
Sponsors
Rede Optimus Hospitalar SA
iVascular S.L.U.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization. 2. Left main diameter ≤6.00 mm. 3. LAD and LCx diameter both \>2.75 mm, evaluated by visual estimation.
Exclusion criteria
1. Subjects with ages 18 or below at the time of the procedure. 2. Female subjects who may be pregnant or breast-feeding at the time of the procedure. 3. Previous PCI of the left main bifurcation. 4. Chronic total occlusion of the LAD or LCx. 5. Trifurcating left main requiring treatment of the 3 branches. 6. LAD and LCx reference sizes are out of the sizing ranges of the used DES/DCB families. 7. In-stent restenosis as target lesion. 8. Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system. 9. ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease. 10. Cardiogenic shock. 11. Left ventricular ejection fraction below 35%. 12. Decision to use mechanical circulatory support for protected PCI. 13. Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation). 14. Associated significant valvular disease. 15. Renal insufficiency with glomerular filtration rate (GFR) \< 20. 16. Life expectancy less than one year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiography-based late lumen loss | 12 months post procedure | Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate | at index procedure | Conversion rate to double-stent technique |
| Procedure time | at index procedure | Duration of index procedure |
| Used contrast media | at index procedure | Used contrast media at index procedure |
| Radiation dose | at index procedure | Radiation dose at index procedure |
| Delta μQFR in the LAD and in the LCx | at index procedure and at12 months post procedure | Delta μQFR in the LAD and in the LCx between acute (index procedure) and 12 months follow-up |
| Malposition rate | at 12 months post procedure | Malapposition rate by OCT |
| Underexpansion rate | at 12 months post procedure | Underexpansion rate by OCT |
| Diameter stenosis | at 12 months post procedure | Diameter stenosis based on quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium |
| 2. Late lumen loss | at 12 months post procedure | Late lumen loss at the level of proximal- and distal main branch (primarily stented branch) |
| Stent thrombosis rate | at 12 months post procedure | Stent thrombosis rate (acute, subacute, late) at 12 months. |
| Optical coherence tomography (OCT)-based minimal stent / lumen area | at 12 months post procedure | 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 | at 12 months post procedure | OCT-based area stenosis at the level of LM, LAD ostium and LCx ostium |
| Acute lumen gain (2D) | at index procedure | Acute lumen gain based on 2D quantitative coronary angiography |
| Acute lumen gain (3D) | at index procedure | Acute lumen gain based on 3D quantitative coronary angiography |
| Acute functional result | at index procedure | Acute functional result in the LAD and in the LCx, defined by Murray law-based quantitative flow ratio (μQFR) |
| Functional result in the LAD and in the LCx | at 12 months post procedure | Functional result in the LAD and in the LCx, defined by μQFR |
| Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure | at 6 months and 12 months pos procedure | Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure |
| Death | from index procedure to 12 months post procedure | Death upon 12 months |
| Myocardial Infarction | from index procedure to 12 months post procedure | Myocardial Infarction upon 12 months. |
| Target vessel revascularization | from index procedure to 12 months post procedure | Target vessel revascularization upon 12 months. |
| Area stenosis | at 12 months post procedure | Area stenosis based on 3D quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium |
| Hospitalization for heart failure | from index procedure to 12 months post procedure | Hospitalization for heart failure upon 12 months. |
Contacts
CONTACTAnnelena Held, PhD, MSc
CONTACTMelissa Munoz Beilis, MD
PRINCIPAL_INVESTIGATORGábor Tóth, MD, PhD
Medical University of Graz
Outcome results
None listed