Coronary Artery Disease
Conditions
Keywords
Drug Eluting Balloon, Coronary, De Novo coronary lesions
Brief summary
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
Detailed description
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.
Interventions
DEVICESELUTION SLR
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).
DEVICEDES
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.
Sponsors
M.A. Med Alliance S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TVF | 1 year after treatment | \- TVF (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-TVR) at 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death or any MI | 30 days after treatment | Cardiac death, non-cardiac death, or any Myocardial Infarction |
| CD-TVR | 30 days after treatment | Clinically driven - Target Vessel Revascularization |
| TVF | 2, 3, 4, 5 years after treatment | Target Vessel Failure |
| Any revascularization | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 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 |
| Myocardial Infarction (MI) | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 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 |
| Composite of cardiac death or target vessel MI | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | Composite of cardiac death or target vessel Myocardial Infarction |
| All-cause mortality | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | * Cardiac mortality * Non-cardiac mortality |
| Patient-oriented ARC-2 composite endpoint | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 1. All-cause mortality 2. Any stroke 3. Any MI (includes non-target vessel territory) 4. Any revascularization |
| Site-reported stroke | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | Site-reported stroke |
| Site-reported BARC 3-5 Bleeding | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | Site-reported BARC (Bleeding Academic Research Consortium ) 3-5 Bleeding |
| Cost-effectiveness of DEB vs. DES after 12 months in selected countries | 1, 2, 3, 4 and 5 years after treatment | Total costs of materials used during treatment |
| Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5 bleeding | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | Net clinical benefit, a combination of freedom from (Target Vessel Failure) TVF and/or BARC 3-5 bleeding |
| Device success | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | Device success defined as achievement of a final residual diameter stenosis of \< 30% (site-reported), using the assigned device only |
| Lesion success | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | Lesion success defined as achievement of \< 30% residual stenosis (site-reported), using any PCI method |
| Procedure success | 30 days, 6 months, 1, 2, 3, 4 and 5 years after treatment | 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 |
Countries
Austria, Czechia, Finland, France, Germany, Italy, Netherlands, Poland, Singapore, Spain, Switzerland, United Kingdom
Outcome results
None listed