Multivessel TALENT
Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
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
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.
Sites / Locations
- NUIGRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SUPRAFLEX Cruz
SYNERGY
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.