The SELUTION DeNovo Study

Study Overview
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Brief Summary
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A Prospective Randomized, Multi-center, International, Single-blind, Clinical trial compared the Selution DEB strategy versus DES strategy.

Detailed Description
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Randomized, multi-center, international, single-blind, clinical trial. Patients meeting eligibility criteria will be randomized 1:1 to treatment of all lesions of the identified trial target vessel(s) with either the SELUTION SLR DEB or DES. Patients randomized to the SELUTION SLR DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION DEB group (intention to treat analysis). Patients randomized to the DES arm will receive treatment using any CE-marked DES, as per standard institutional practice. Patients with failure to deliver DES will be first treated by provisional DEB using the SELUTION DEB, and failing that, with any other device deemed appropriate. Staged procedures are allowed if they are planned less than 45 days after the index procedure and are done according to the initial treatment allocation for all trial target vessels (DEB if DEB arm, DES if DES arm). The study will test: for non-inferiority of a DEB plus provisional DES treatment strategy versus a systematic DES strategy with respect to the primary endpoint of TVF at 12 months. for long-term superiority at 5 years of the DEB strategy with TVF as an endpoint All Patients will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.

Official Title
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SELUTION DeNovo - A Prospective Randomized, Multi-center, International, Single-blind, Clinical Trial Compared the Selution DEB Strategy Versus DES Strategy.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: SELUTION SLR
* Device: DES


Participation Criteria
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Eligibility Criteria
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Subjects must meet all the following criteria to participate in the trial: Subject age is ≥ 18 years (or 21 according to countries legal age) Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure or are using a contraceptive device or drug. Documented angina and/or positive functional testing or unstable angina or stabilized NSTEMI presentation. Life expectancy >1 year Written informed consent by the subject or her/his legally authorized representative for participation in the study One or more native target vessel (LAD, LCX or RCA) is considered to require intervention and is suitable for treatment of all lesions with either DEB + provisional stenting or with DES and is identified as such. The number of trial target lesions is not limited, but in the operator's opinion, if the subject is randomized to the DEB arm, the likelihood of the subject requiring provisional stenting of any of the identified trial target lesions is < 30%, and if randomized to the systematic DES arm, all lesions are considered amenable to stenting. All target lesions: diameter between 2.0 and 5 mm, and diameter stenosis >50% and <100% with distal flow at least TIMI 2 Exclusion Criteria: Age < 18 years (or 21 according to countries legal age) Subject is pregnant or breast-feeding Definite or suspected clinically active covid-19 infection Subject is under judicial protection, tutorship or curatorship (for France only) Subject is unable to fully comply with the study protocol Contraindications to dual antiplatelet therapy, sirolimus or its analogues Presentation with STEMI Presentation with NSTEMI and ongoing chest pain or hemodynamic instability Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock) Chronic NYHA class III or IV heart failure prior to index PCI Known LVEF < 30% prior to index PCI Previous PCI of a trial target vessel at any time Previous PCI of a non-trial target vessel within 30 days Trial target lesion located in the left main or any arterial or venous graft Trial target lesion is chronic total occlusion (CTO) or in-stent restenosis (ISR) Subject considered not able to tolerate at least 30 seconds of coronary occlusion for each trial target lesion RVD of trial target lesion > 5mm Planned major surgery within one month following the procedure Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SELUTION SLR DEB<br>Device: SELUTION SLR DEB. For patients randomized to the DEB strategy, all target lesions should be treated with DEB after appropriate lesion preparation, but provisional DES implantation is acceptable if the angiographic result is considered insufficient either after lesion preparation of after DEB treatment (poor flow, dissection type C or higher, residual stenosis > 30%). For bifurcation lesions, when both main and side- branch are considered to require treatment, a DEB should be used for both. | Device: SELUTION SLR<br>* Patients randomized to the SELUTION SLR™ DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION SLR™ DEB group (intention to treat analysis).<br>|
| Other: DES<br>Device: Drug Eluting Stent. For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB. | Device: DES<br>* For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TVF | - TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR) at 1 year | 1 year after treatment | 
| TVF | - TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR)) at 5 years | 5 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or any MI | Cardiac death, non-cardiac death, or any Myocardial Infarction | 30 days after treatment | 
| CD-TVR | Clinically driven - Target Vessel Revascularization | 30 days after treatment | 
| TVF | Target Vessel Failure | 2, 3, 4, 5 years after treatment | 
| Any revascularization | Target lesion revascularization (TLR) - any and clinically driven Target vessel revascularization (TVR) - any and clinically driven A new lesion revascularization in a target vessel Non-Target vessel revascularization | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| Myocardial Infarction (MI) | Peri-procedural MI Target-vessel MI Non-target-vessel MI MI type (1 to 5) according to the 4th universal definition | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| Composite of cardiac death or target vessel MI | Composite of cardiac death or target vessel Myocardial Infarction | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| All-cause mortality | Cardiac mortality Non-cardiac mortality | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| Patient-oriented ARC-2 composite endpoint | All-cause mortality Any stroke Any MI (includes non-target vessel territory) Any revascularization | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| Site-reported stroke | Site-reported stroke | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| Site-reported BARC 3-5 Bleeding | Site-reported BARC (Bleeding Academic Research Consortium ) 3-5 Bleeding | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| Cost-effectiveness of DEB vs. DES after 12 months in selected countries | Total costs of materials used during treatment | 1, 2, 3, 4 and 5 years after treatment | 
| Cost-effectiveness of DEB vs. DES after 12 months in selected countries | Time of procedure. Total minutes from patient introducer introduction until removal | 1, 2, 3, 4 and 5 years after treatment | 
| Cost-effectiveness of DEB vs. DES after 12 months in selected countries | Total hospitalization days per procedure. | 1, 2, 3, 4 and 5 years after treatment | 
| Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding | Net clinical benefit, a combination of freedom from (Target Vessel Failure) TVF and/or BARC 3-5 bleeding | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| Device success | Device success defined as achievement of a final residual diameter stenosis of < 30% (site-reported), using the assigned device only | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| Lesion success | Lesion success defined as achievement of < 30% residual stenosis (site-reported), using any PCI method | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 
| Procedure success | Procedure success defined as achievement of a final diameter stenosis of < 30% (site-reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary, De Novo coronary lesions, Drug Eluting Balloon