Clinical trial NCT04390672: Multivessel TALENT
Official title: A Randomized Controlled Trial to Compare the Safety and Efficacy of siroliMUs-eLuTIng Biodegradable Polymer ulTrA-thin Stent (SUPRAFLEX Cruz) and Everolimus-eLuting Biodegradable Polymer Stent (SYNERGY) in treatmENT for Three-vessel Coronary Artery Disease: Multivessel TALENT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Keywords: multi-vessel coronary artery disease
revascularization
quantitative flow ratio
fractional flow reserve
instant wave-free ratio
SYNTAX score
prasugrel monotherapy
ultra-thin strut sirolimus-eluting coronary stent
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 1550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multivessel TALENT is a prospective, randomized, multi-center study comparing clinical outcomes between SUPRAFLEX Cruz and SYNERGY in approximately 1550 patients with de-novo three vessel disease undergoing percutaneous coronary intervention (PCI). Patients will be treated according to "state of art PCI"; not only treatment strategies based on the latest ESC guideline, such as SYNTAX Score II recommendation, Heart Team discussion, post-procedure intravascular imaging optimization, cholesterol reduction by statin or PCSK-9 inhibitor, but also exploratory treatment strategies based on the latest evidence, such as physiological assessment using quantitative flow ratio and prasugrel monotherapy following 1-month dual antiplatelet therapy after PCI.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients' ≥18 years.
2. At least 1 stenosis (angiographic, visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, LCX and/or side branch, RCA and/or side branch) supplying viable myocardium without left main involvement.
3. The vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.50 mm (no limitation on the number of treated lesions, vessels, or lesion length).
4. Patients with chronic coronary syndrome or stabilized acute coronary syndromes.
5. All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II, provided that the SYNTAX Score II recommends equipoise risk (PCI or CABG) or PCI only.
6. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required evaluations.
7. Agree with conditional longer follow up from 2 to 5 years with one phone contact yearly.

Exclusion Criteria:

1. Under the age of 18.
2. Unable to give informed consent.
3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice).
4. Known contraindication to medications such as Aspirin, Heparin, Bivalirudin, Prasugrel and Ticagrelor.
5. Prior PCI or prior CABG.
6. Ongoing ST-elevation myocardial infarction (STEMI).
7. Cardiogenic shock is also an exclusion criteria.
8. Concurrent medical condition with a life expectancy of less than 2 years.
9. Currently participating in another trial and not yet at its primary endpoint.
10. Patient with both ostial LAD and ostial LCX stenosis, or left main stenosis.
11. Previous intracranial haemorrhage.

Primary outcomes:
measure: Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Number of vessels with a composite of vessel-related cardiovascular death, vessel-related MI, or CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)
timeFrame: 24 months post-procedure
measure: Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation
timeFrame: 24 months post-procedure
measure: Number of participants with all cause death
timeFrame: 12 and 24 months post-procedure
measure: Number of Participants with any stroke
timeFrame: 12 and 24 months post-procedure
measure: Number of Participants with any myocardial infarction
timeFrame: 12 and 24 months post-procedure
measure: Number of Participants with any (repeat) revascularisation
timeFrame: 12 and 24 months post-procedure
measure: Number of vessels with vessel-related cardiovascular death
timeFrame: 12 and 24 months post-procedure
measure: Number of vessels with vessel-related MI
timeFrame: 12 and 24 months post-procedure
measure: Number of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)
timeFrame: 12 and 24 months post-procedure
measure: Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target lesion revascularization
timeFrame: 12 and 24 months post-procedure
measure: Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation
timeFrame: 12 and 24 months post-procedure
measure: Number of participants with cardiovascular death
timeFrame: 12 and 24 months post-procedure
measure: Number of participants with target vessel MI
timeFrame: 12 and 24 months post-procedure
measure: Number of participants with clinically-indicated target lesion revascularisation
timeFrame: 12 and 24 months post-procedure
measure: Number of participants with Definite/Probable Stent thrombosis
timeFrame: 12 and 24 months post-procedure
measure: Number of participants with device success
timeFrame: 7days post-procedure
measure: Number of participants with procedure success
timeFrame: 7days post-procedure
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: NUIG
Study officials:
affiliation: National University of Ireland, Galway
name: Patrick W. Serruys, MD, PhD
role: STUDY_CHAIR
affiliation: National University of Ireland, Galway
name: William Wijns, MD, PhD
role: STUDY_CHAIR
affiliation: National University of Ireland, Galway
name: Yoshinobu Onuma, MD, PhD
role: STUDY_CHAIR
affiliation: St. Johannes Hospital
name: Helge Moellmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic of Barcelona
name: Manel Sabate, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Freeman Hospital and Newcastle University
name: Azfar Zaman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hara H, Gao C, Kogame N, Ono M, Kawashima H, Wang R, Morel MA, O'Leary N, Sharif F, Mollmann H, Reiber JHC, Sabate M, Zaman A, Wijns W, Onuma Y, Serruys PW. A randomised controlled trial of the sirolimus-eluting biodegradable polymer ultra-thin Supraflex stent versus the everolimus-eluting biodegradable polymer SYNERGY stent for three-vessel coronary artery disease: rationale and design of the Multivessel TALENT trial. EuroIntervention. 2020 Dec 18;16(12):e997-e1004. doi: 10.4244/EIJ-D-20-00772.