The SELUTION DeNovo Study

N/AActive Not RecruitingNCT04859985

M.A. Med Alliance S.A.3,326 enrolled

Overview

A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.

Randomized, multi-centre, international, open label, 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: 1. 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. 2. 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 5 years. If non-inferiority is then established, superiority of the DEB strategy with TVF as an endpoint will be tested. All Patients will be followed for clinical outcomes at 30 days, 6 months, 1 2, 3, 4 and 5 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

3,326

Conditions

Coronary Artery Disease

Interventions

SELUTION SLRDEVICE

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).

DESDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (62)

Outcomes

Primary Outcomes

TVF

\- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR) at 1 year

Time frame: 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

Time frame: 5 years after treatment

Secondary Outcomes

Death or any MI

Cardiac death, non-cardiac death, or any Myocardial Infarction

Time frame: 30 days after treatment

CD-TVR

Clinically driven - Target Vessel Revascularization

Time frame: 30 days after treatment

TVF

Target Vessel Failure

Time frame: 2, 3, 4, 5 years after treatment

Any revascularization

1. Target lesion revascularization (TLR) - any and clinically driven 2. Target vessel revascularization (TVR) - any and clinically driven 3. A new lesion revascularization in a target vessel 4. Non-Target vessel revascularization

Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment

Myocardial Infarction (MI)

1. Peri-procedural MI 2. Target-vessel MI 3. Non-target-vessel MI 4. MI type (1 to 5) according to the 4th universal definition

Time frame: 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment

Composite of cardiac death or target vessel MI

Data from ClinicalTrials.gov

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