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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04390672
Other study ID # NUIG-2020-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 22, 2020
Est. completion date August 2026

Study information

Verified date April 2024
Source National University of Ireland, Galway, Ireland
Contact Patrick W. Serruys, MD, PhD
Phone +353 91459047
Email multivtcoord@nuigalway.ie
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1550
Est. completion date August 2026
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Device:
SUPRAFLEX Cruz
Percutaneous Coronary Intervention for multivessel disease
SYNERGY
Percutaneous Coronary Intervention for multivessel disease

Locations

Country Name City State
Ireland NUIG Galway

Sponsors (1)

Lead Sponsor Collaborator
National University of Ireland, Galway, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation a non-inferiority comparison of Patient-oriented Composite Endpoint (POCE) of the SUPRAFLEX Cruz cohort to the SYNERGY cohort at 12 months post-procedure. POCE is a composite clinical endpoint of:
All cause death;
Any stroke, Modified Rankin Scale (MRS =1);
Any myocardial infarction (MI);
Any (repeat) revascularisation
12 months post-procedure
Secondary Number of vessels with a composite of vessel-related cardiovascular death, vessel-related MI, or CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation) a superiority comparison in the as treated population (per vessel level) of the vessel-oriented composite endpoints (VOCE).
VOCE is a composite clinical endpoint of:
Vessel-related cardiovascular death;
Vessel-related MI;
CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation).
24 months post-procedure
Secondary Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation a comparison of Patient-oriented Composite Endpoint (POCE) of the SUPRAFLEX Cruz cohort to the SYNERGY cohort at 24 months post-procedure. POCE is a composite clinical endpoint of:
All cause death;
Any stroke, Modified Rankin Scale (MRS =1);
Any myocardial infarction (MI);
Any (repeat) revascularisation
24 months post-procedure
Secondary Number of participants with all cause death a comparison of numbers of participants with all cause death 12 and 24 months post-procedure
Secondary Number of Participants with any stroke a comparison of numbers of participants with any stroke 12 and 24 months post-procedure
Secondary Number of Participants with any myocardial infarction a comparison of numbers of participants with any myocardial infarction 12 and 24 months post-procedure
Secondary Number of Participants with any (repeat) revascularisation a comparison of number of participants with any (repeat) revascularisation 12 and 24 months post-procedure
Secondary Number of vessels with vessel-related cardiovascular death a comparison of numbers of vessels with vessel-related cardiovascular death 12 and 24 months post-procedure
Secondary Number of vessels with vessel-related MI a comparison of numbers of vessels with vessel-related MI 12 and 24 months post-procedure
Secondary Number of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation) a comparison of numbers of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation) 12 and 24 months post-procedure
Secondary Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target lesion revascularization a comparison of numbers of participants with TLF / DOCE defined as cardiovascular death, target vessel MI and clinically-indicated target lesion revascularisation 12 and 24 months post-procedure
Secondary Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation a comparison of numbers of participants with TVF defined as cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation 12 and 24 months post-procedure
Secondary Number of participants with cardiovascular death a comparison of numbers of participants with cardiovascular death 12 and 24 months post-procedure
Secondary Number of participants with target vessel MI a comparison of numbers of participants with target vessel MI 12 and 24 months post-procedure
Secondary Number of participants with clinically-indicated target lesion revascularisation a comparison of numbers of participants with clinically-indicated target lesion revascularisation 12 and 24 months post-procedure
Secondary Number of participants with Definite/Probable Stent thrombosis a comparison of numbers of participants with Definite/Probable Stent thrombosis 12 and 24 months post-procedure
Secondary Number of participants with device success a comparison of numbers of participants with device success 7days post-procedure
Secondary Number of participants with procedure success a comparison of numbers of participants with procedure success (Device success + free from POCE at discharge) 7days post-procedure
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