coronary heart disease I25.13
Conditions
Interventions
Group 1: Arm 1: SUPRAFLEXTM Cruz Sirolimus-abgebender Stents (SES)
Group 2: Arm 2: SYNERGYTM Everolimus-abgebender Stent (EES)
Sponsors
National University Ireland Galway
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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*; *patients with ostial LAD or ostial LCX - Medina 0,0,1 or Medina 0,1,0 – may be enrolled; Patients with hypoplastic RCA (or LCX) with absence of descending posterior and presence of a lesion in the LAD and LCX (or RCA) territories may be included in the trial as a 3VD equivalent. 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 1 or stabilized acute coronary syndromes**; **For patients showing elevated Troponin (e.g. nonSTEMI patients) at baseline (within 72h pre-PCI) an additional blood sample must be collected prior to randomisation to confirm that: - hs-cTn or Troponin I or T levels are stable (i.e. the value should be within 20% range of the value found inthe first sample at baseline, or shown any decline.) - or CK-MB and CK levels are within normal range In summary, If hs-cTn or Troponin I or T levels are stable or have dropped,or CK-MB and CK levels are within normal range, and the ECG does not show STelevation, the patient may be included in the study. In case where both enzymes are available, troponin criteria are hierarchically dominant. 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 protocolrequired evaluations;
Exclusion criteria
Exclusion criteria: 1. Under the age of 18. 2. Unable to give informed consent. 3. Patient is a woman who is pregnant or nursing (apregnancy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To compare the SUPRAFLEXTM Cruz sirolimus-eluting stent (SES) with the SYNERGY TM everolimus-eluting stent (EES) with respect to Patient-oriented Composite Endpoint (POCE: composite of all-cause death, any stroke, any MI, and any clinically and physiologically-indicated revascularisation) at 12 months in a 3-vessel disease population (non-inferiority); | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: To compare the SUPRAFLEXTM Cruz SES with the SYNERGYTM EES with respect to Vessel-oriented Composite Endpoint (VOCE, composite of vessel-related cardiovascular death, vessel-related MI, clinically and physiologically-indicated-Target vessel revascularisation) per vessel at 24 months in a 3-vessel disease population (superiority); | — |
Countries
France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom
Contacts
Public ContactHelge Möllmann
St. Johannes Hospital Dortmund, Klinik für Innere Medizin
Outcome results
None listed