Coronary Artery Disease Clinical Trial
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
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.
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. |
Country | Name | City | State |
---|---|---|---|
Ireland | NUIG | Galway |
Lead Sponsor | Collaborator |
---|---|
National University of Ireland, Galway, Ireland |
Ireland,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |