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

N/ANot Yet RecruitingNCT07408674

Rede Optimus Hospitalar SA186 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

186

Conditions

Complex Left Main Bifurcation Stenosis Left Main Coronary Artery Stenosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Angiography-based late lumen loss

Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch)

Time frame: 12 months post procedure

Secondary Outcomes

2. Late lumen loss

Late lumen loss at the level of proximal- and distal main branch (primarily stented branch)

Time frame: at 12 months post procedure

Stent thrombosis rate

Stent thrombosis rate (acute, subacute, late) at 12 months.

Time frame: 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.

Time frame: at 12 months post procedure

OCT-based area stenosis

OCT-based area stenosis at the level of LM, LAD ostium and LCx ostium

Time frame: at 12 months post procedure

Acute lumen gain (2D)

Acute lumen gain based on 2D quantitative coronary angiography

Time frame: at index procedure

Acute lumen gain (3D)

Acute lumen gain based on 3D quantitative coronary angiography

Time frame: 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)

Time frame: at index procedure

Functional result in the LAD and in the LCx

Functional result in the LAD and in the LCx, defined by μQFR

Time frame: 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

Time frame: at index procedure and at12 months post procedure

Malposition rate

Malapposition rate by OCT

Time frame: at 12 months post procedure

Underexpansion rate

Underexpansion rate by OCT

Time frame: at 12 months post procedure

Diameter stenosis

Diameter stenosis based on quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium

Time frame: 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

Time frame: at 12 months post procedure

Conversion rate

Conversion rate to double-stent technique

Time frame: at index procedure

Procedure time

Duration of index procedure

Time frame: at index procedure

Used contrast media

Used contrast media at index procedure

Time frame: at index procedure

Radiation dose

Radiation dose at index procedure

Time frame: at index procedure

Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure

Time frame: at 6 months and 12 months pos procedure

Death

Death upon 12 months

Time frame: from index procedure to 12 months post procedure

Myocardial Infarction

Myocardial Infarction upon 12 months.

Time frame: from index procedure to 12 months post procedure

Target vessel revascularization

Target vessel revascularization upon 12 months.

Time frame: from index procedure to 12 months post procedure

Hospitalization for heart failure

Hospitalization for heart failure upon 12 months.

Time frame: from index procedure to 12 months post procedure

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts