1. At 1 year, to demonstrate non-inferiority for target vessel failure (TVF) of a treatment strategy with first line SELUTION SLR* DEB + provisional DES vs. systematic treatment with DES for the treatment of de novo coronary lesions.2. At 5-year…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• TVF (target vessel failure: cardiac death, target-vessel related myocardial
infarction (MI) or clinically driven target vessel revascularization (cd-TVR))
at 1 year
• TVF at 5 years
Secondary outcome
• At 30-days:
o safety endpoint (cardiac death, non-cardiac death, or any MI)
o efficacy (cd-TVR)
• TVF at 2, 3, and 4 years.
• Other endpoints at 30 days, 6 months, 1, 2, 3, 4 and 5 years
1. Any revascularization
a. Target lesion revascularization (TLR) - any and clinically driven
b. Target vessel revascularization (TVR) - any and clinically driven
c. A new lesion revascularization in a target vessel
d. Non-Target vessel revascularization
2. Myocardial Infarction
a. Peri-procedural MI
b. Target-vessel MI
c. Non-target-vessel MI
d. MI type (1 to 5) according to the 4th universal definition
3. Composite of cardiac death or target vessel MI
4. Lesion Thrombosis
5. All-cause mortality
6. Cardiac mortality
7. Non-cardiac mortality
8. Patient-oriented ARC-2 composite endpoint:
a. All-cause mortality
b. Any stroke
c. Any MI (includes non-target vessel territory)
d. Any revascularization
9. Stroke
10. BARC 3-5 Bleeding
11. Cost-effectiveness of DEB vs. DES after 12 months in selected countries
12. Net clinical benefit, a combination of freedom from TVF and/or BARC 3-5
bleeding
13. Device success defined as achievement of a final residual diameter stenosis
of < 30% (site-reported), using the assigned device only
14. Lesion success defined as achievement of < 30% residual stenosis
(sitereported), using any percutaneous method
15. 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
Background summary
Percutaneous Coronary Intervention (PCI) with stent implantation has been
widely used as an alternative to medical or surgical treatment in selected
subjects with symptomatic coronary artery disease. Although the use of metal
coronary stents is rapidly increased owing to the advancement of safety and
efficacy of newer generation drug-eluting (DES), patients are not completely
free from their inherent limitations such as stent thrombosis or restenosis
including neoatherosclerosis and obligatory use of dual antiplatelet therapy
(DAPT) with unknown optimal duration
Over the past 10 years, increasing interest has therefore been devoted to
treatment options that would allow to *leave nothing behind*.
Drug-coated balloon (DCB) treatment follows the leaving nothing behind concept
and therefore it is not limited by stent thrombosis and long-term DAPT because
it delivers directly anti-proliferative drug which is coated to balloon after
improving coronary blood flow with balloon angioplasty.
DCBs usually consist of semi-compliant balloons with an active drug embedded in
a matrix. After inflation of the balloon, the drug is transferred to the vessel
wall where is exerts its anti-proliferative action.
The SELUTION SLR* 014 PTCA is a Sirolimus-Eluting Balloon catheter for
Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures. The drug
coating on the balloon part of the SELUTION SLR* 014 PTCA is a proprietary
formulation, consisting of Sirolimus (also known as Rapamycin) as the Active
Pharmaceutical Ingredient (API) and four excipients.
Its unique features allow controlled and effective elution of sirolimus into
the vessel wall, and justify the DEB (drug eluting balloon) acronym, since
other DCBs have a much shorter drug delivery time. The safety and efficacy of
the SELUTION SLR* 014 DEB will be tested in this all-comer study, the Selution
DeNovo trial.
Should the DEB + provisional DES prove to be the superior strategy, it has the
potential to profoundly modify current PCI practice worldwide, since, despite
its limitations, stent implantation has been the mainstay of PCI for the past
30 years.
Study objective
1. At 1 year, to demonstrate non-inferiority for target vessel failure (TVF) of
a treatment strategy with first line SELUTION SLR* DEB + provisional DES vs.
systematic treatment with DES for the treatment of de novo coronary lesions.
2. At 5-year follow-up, to demonstrate non-inferiority for TVF of the DEB +
provisional DES vs. the systematic DES treatment strategy. If non-inferiority
is achieved, a superiority test will be performed.
Study design
prospective randomized, multi-center, International, open label, clinical
trial
Intervention
Subjects who satisfy all clinical and angiographic inclusion and exclusion
criteria will be randomized in a 1:1 ratio to be treated for all the identified
target lesions either with the SELUTION SLR* DEB + provisional DES strategy or
the systematic DES strategy.
Study burden and risks
In this study patients are treated by CE-certified medical devices within their
intended purpose. The medical devices used in the study, SELUTION SLR* Eluting
Balloon (DEB) and the drug-eluting stents used in the study are commercially
available and are already being already used in practice for the treatment of
coronary heart disease.
The patients included in this study would have to undergo angioplasty anyway
due to their underlying disease, otherwise the patients could not be included
in this study due to the inclusion and exclusion criteria. be included in this
study. The angioplasty procedure, including pre- and post-procedure
examinations, will be performed as usual at the study center and therefore does
not represent an additional burden.
After 1, 6, 12, 24, 36, 48 and 60 months, patients are asked questions about
their state of health and medications taken during telephone contacts which
will take about 20 mins each.
The medical risks for patients are not increased by participation in the study
compared to treatment outside the study.
The risk of patients is minimally increased by the risk inherent to data
collection. This risk has been mitigated by procedures that have been put in
place to proctect the participating subjects' personal information.
Since the patients could be treated in the same way also outside the study,
there is no direct personal benefit for the patients resulting from the study
participation. The results of the study may contribute to determine what is the
best treatment strategy for patients with coronary artery disease.
In addition, an independent Data Safety Monitoring Board will monitor safety of
the subjects throughout the clinical investigation and a Clinical Events
Committee will adjudicate adverse events as per the definitions in the CEC
charter.
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Listed location countries
Age
Inclusion criteria
• 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, patients whose Index procedure is a staged
procedure for non-culprit lesion PCI after Acute Myocardial Infarction (AMI)
may be included in the absence of further documented ischemia/angina.
• Life expectancy >1 year
• Written informed consent by the subject 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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04859985 |
| CCMO | NL85239.042.23 |