A randomized controlled trial to compare the safety and efficacy of siroliMUs-eLuTIng biodegradable polymer ulTrA-thin stent (SUPRAFLEXTM Cruz) and everolimus-eLuting biodegradable polymer stent (SYNERGYTM) in treatmENT for three-vessel coronary artery disease
- Conditions
- 3-vessel coronary artery disease10011082
- Registration Number
- NL-OMON56460
- Lead Sponsor
- Clinical Science Institute, National University of Ireland, Galway,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
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 syndrome1 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.
1. Under the age of 18.
2. Unable to give informed consent.
3. Patient is a woman who is pregnant or nursing;
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The Primary Endpoint for this trial is a non-inferiority comparison of<br /><br>Patient-oriented Composite Endpoint (POCE) of the SUPRAFLEXTM Cruz cohort to<br /><br>the SYNERGYTM cohort at 12 months post-procedure. POCE4 is a composite clinical<br /><br>endpoint of<br /><br>- all cause death<br /><br>- any stroke, Modified Rankin scale, (MRS >=1);<br /><br>- any myocardial infarction (MI)*<br /><br>- any (repeat) revascularization.<br /><br><br /><br>*SCAI consensus for peri-procedural MI <=48 hours, and Fourth Universal<br /><br>Definition (FUD) for spontaneous MI >48 hours after index procedure.</p><br>
- Secondary Outcome Measures
Name Time Method