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| Name | Class |
|---|---|
| iVascular S.L.U. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Stenting | Active Comparator | Angiolite, iVascular |
|
| DBC-enhanced Stenting | Experimental | Essential Pro, iVascular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiolite Sirolimus-Eluting Stenting | Device | Conventional Provisional Stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiography-based late lumen loss | Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch) | 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 2. Late lumen loss | Late lumen loss at the level of proximal- and distal main branch (primarily stented branch) | at 12 months post procedure |
| Stent thrombosis rate | Stent thrombosis rate (acute, subacute, late) at 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annelena Held, PhD, MSc | Contact | +49 157 86743867 | annelena.held@redeoptimus.com | |
| Melissa Munoz Beilis, MD | Contact | +49 176 720 75 997 | melissa.munoz@redeoptimus.com |
| Name | Affiliation | Role |
|---|---|---|
| Gábor Tóth, MD, PhD | Medical University of Graz | Principal Investigator |
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| Essential Pro Paclitaxel Drug-Eluting Balloon | Device | Drug-Coated Balloon |
|
|
| at 12 months post procedure |
| 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. | at 12 months post procedure |
| OCT-based area stenosis | OCT-based area stenosis at the level of LM, LAD ostium and LCx ostium | at 12 months post procedure |
| Acute lumen gain (2D) | Acute lumen gain based on 2D quantitative coronary angiography | at index procedure |
| Acute lumen gain (3D) | Acute lumen gain based on 3D quantitative coronary angiography | at index procedure |
| Acute functional result | Acute functional result in the LAD and in the LCx, defined by Murray law-based quantitative flow ratio (μQFR) | at index procedure |
| Functional result in the LAD and in the LCx | Functional result in the LAD and in the LCx, defined by μQFR | at 12 months post procedure |
| Delta μQFR in the LAD and in the LCx | Delta μQFR in the LAD and in the LCx between acute (index procedure) and 12 months follow-up | at index procedure and at12 months post procedure |
| Malposition rate | Malapposition rate by OCT | at 12 months post procedure |
| Underexpansion rate | Underexpansion rate by OCT | at 12 months post procedure |
| Diameter stenosis | Diameter stenosis based on quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium | at 12 months post procedure |
| Area stenosis | Area stenosis based on 3D quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium | at 12 months post procedure |
| Conversion rate | Conversion rate to double-stent technique | at index procedure |
| Procedure time | Duration of index procedure | at index procedure |
| Used contrast media | Used contrast media at index procedure | at index procedure |
| Radiation dose | Radiation dose at index procedure | at index procedure |
| Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure | Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure | at 6 months and 12 months pos procedure |
| Death | Death upon 12 months | from index procedure to 12 months post procedure |
| Myocardial Infarction | Myocardial Infarction upon 12 months. | from index procedure to 12 months post procedure |
| Target vessel revascularization | Target vessel revascularization upon 12 months. | from index procedure to 12 months post procedure |
| Hospitalization for heart failure | Hospitalization for heart failure upon 12 months. | from index procedure to 12 months post procedure |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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