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Multivessel TALENT

Primary Purpose

Coronary Artery Disease, Myocardial Ischemia, Coronary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
SUPRAFLEX Cruz
SYNERGY
Sponsored by
National University of Ireland, Galway, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NUIGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SUPRAFLEX Cruz

SYNERGY

Arm Description

Percutaneous Coronary Intervention with the SUPRAFLEX Cruz Sirolimus Eluting Bioabsorbable Polymer Coronary Stent System. It is a balloon expandable sirolimus eluting stent with an bioabsorbable polymer coating.

Percutaneous Coronary Intervention with the SYNERGY EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with an bioabsorbable polymer coating.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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
Number of participants with all cause death
a comparison of numbers of participants with all cause death
Number of Participants with any stroke
a comparison of numbers of participants with any stroke
Number of Participants with any myocardial infarction
a comparison of numbers of participants with any myocardial infarction
Number of Participants with any (repeat) revascularisation
a comparison of number of participants with any (repeat) revascularisation
Number of vessels with vessel-related cardiovascular death
a comparison of numbers of vessels with vessel-related cardiovascular death
Number of vessels with vessel-related MI
a comparison of numbers of vessels with vessel-related MI
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)
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
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
Number of participants with cardiovascular death
a comparison of numbers of participants with cardiovascular death
Number of participants with target vessel MI
a comparison of numbers of participants with target vessel MI
Number of participants with clinically-indicated target lesion revascularisation
a comparison of numbers of participants with clinically-indicated target lesion revascularisation
Number of participants with Definite/Probable Stent thrombosis
a comparison of numbers of participants with Definite/Probable Stent thrombosis
Number of participants with device success
a comparison of numbers of participants with device success
Number of participants with procedure success
a comparison of numbers of participants with procedure success (Device success + free from POCE at discharge)

Full Information

First Posted
May 1, 2020
Last Updated
April 27, 2023
Sponsor
National University of Ireland, Galway, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT04390672
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SUPRAFLEX Cruz
Arm Type
Experimental
Arm Description
Percutaneous Coronary Intervention with the SUPRAFLEX Cruz Sirolimus Eluting Bioabsorbable Polymer Coronary Stent System. It is a balloon expandable sirolimus eluting stent with an bioabsorbable polymer coating.
Arm Title
SYNERGY
Arm Type
Active Comparator
Arm Description
Percutaneous Coronary Intervention with the SYNERGY EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with an bioabsorbable polymer coating.
Intervention Type
Device
Intervention Name(s)
SUPRAFLEX Cruz
Intervention Description
Percutaneous Coronary Intervention for multivessel disease
Intervention Type
Device
Intervention Name(s)
SYNERGY
Intervention Description
Percutaneous Coronary Intervention for multivessel disease
Primary Outcome Measure Information:
Title
Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation
Description
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
Time Frame
12 months post-procedure
Secondary Outcome Measure Information:
Title
Number of vessels with a composite of vessel-related cardiovascular death, vessel-related MI, or CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)
Description
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).
Time Frame
24 months post-procedure
Title
Number of participants with a composite of all cause death, any stroke, any myocardial infarction (MI), and any (repeat) revascularisation
Description
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
Time Frame
24 months post-procedure
Title
Number of participants with all cause death
Description
a comparison of numbers of participants with all cause death
Time Frame
12 and 24 months post-procedure
Title
Number of Participants with any stroke
Description
a comparison of numbers of participants with any stroke
Time Frame
12 and 24 months post-procedure
Title
Number of Participants with any myocardial infarction
Description
a comparison of numbers of participants with any myocardial infarction
Time Frame
12 and 24 months post-procedure
Title
Number of Participants with any (repeat) revascularisation
Description
a comparison of number of participants with any (repeat) revascularisation
Time Frame
12 and 24 months post-procedure
Title
Number of vessels with vessel-related cardiovascular death
Description
a comparison of numbers of vessels with vessel-related cardiovascular death
Time Frame
12 and 24 months post-procedure
Title
Number of vessels with vessel-related MI
Description
a comparison of numbers of vessels with vessel-related MI
Time Frame
12 and 24 months post-procedure
Title
Number of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)
Description
a comparison of numbers of vessels with CPI-TVR (clinically and physiologically-indicated-Target vessel revascularisation)
Time Frame
12 and 24 months post-procedure
Title
Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target lesion revascularization
Description
a comparison of numbers of participants with TLF / DOCE defined as cardiovascular death, target vessel MI and clinically-indicated target lesion revascularisation
Time Frame
12 and 24 months post-procedure
Title
Number of participants with a composite of cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation
Description
a comparison of numbers of participants with TVF defined as cardiovascular death, target vessel MI and clinically-indicated target vessel revascularisation
Time Frame
12 and 24 months post-procedure
Title
Number of participants with cardiovascular death
Description
a comparison of numbers of participants with cardiovascular death
Time Frame
12 and 24 months post-procedure
Title
Number of participants with target vessel MI
Description
a comparison of numbers of participants with target vessel MI
Time Frame
12 and 24 months post-procedure
Title
Number of participants with clinically-indicated target lesion revascularisation
Description
a comparison of numbers of participants with clinically-indicated target lesion revascularisation
Time Frame
12 and 24 months post-procedure
Title
Number of participants with Definite/Probable Stent thrombosis
Description
a comparison of numbers of participants with Definite/Probable Stent thrombosis
Time Frame
12 and 24 months post-procedure
Title
Number of participants with device success
Description
a comparison of numbers of participants with device success
Time Frame
7days post-procedure
Title
Number of participants with procedure success
Description
a comparison of numbers of participants with procedure success (Device success + free from POCE at discharge)
Time Frame
7days post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients' ≥18 years. 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. 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). Patients with chronic coronary syndrome or stabilized acute coronary syndromes. 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. 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. Agree with conditional longer follow up from 2 to 5 years with one phone contact yearly. Exclusion Criteria: Under the age of 18. Unable to give informed consent. 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). Known contraindication to medications such as Aspirin, Heparin, Bivalirudin, Prasugrel and Ticagrelor. Prior PCI or prior CABG. Ongoing ST-elevation myocardial infarction (STEMI). Cardiogenic shock is also an exclusion criteria. Concurrent medical condition with a life expectancy of less than 2 years. Currently participating in another trial and not yet at its primary endpoint. Patient with both ostial LAD and ostial LCX stenosis, or left main stenosis. Previous intracranial haemorrhage.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick W. Serruys, MD, PhD
Phone
+353 91459047
Email
multivtcoord@nuigalway.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick W. Serruys, MD, PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William Wijns, MD, PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yoshinobu Onuma, MD, PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helge Moellmann, MD
Organizational Affiliation
St. Johannes Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manel Sabate, MD, PhD
Organizational Affiliation
Hospital Clínic of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azfar Zaman, MD
Organizational Affiliation
Freeman Hospital and Newcastle University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NUIG
City
Galway
ZIP/Postal Code
H91 TK33
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faisal Sharif

12. IPD Sharing Statement

Citations:
PubMed Identifier
32928717
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.
Results Reference
derived

Learn more about this trial

Multivessel TALENT

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