Coronary Artery Lesions Clinical Trial
— TRANSFORMOfficial title:
A Prospective Optical Coherence Tomography (OCT) Study on Coronary Vessel Wall Response to Stent Eluting Everolimus From a Biodegradable Polymer (EES SYNERGY™) Compared With Stent Eluting Zotarolimus From a Durable Polymer (ZES, RESOLUTE Integrity™).
First prospective randomized controlled study to evaluate in an 'all-comers' population with coronary artery disease whether treatment with a novel everolimus eluting stent (EES) with a biodegradable polymer is superior to a durable polymer zotarolimus eluting stent (ZES), with respect to the long term vascular response to treatment These data are important to ascertain the superiority of a new generation DES with bioabsorbable polymer coating to reduce the long term development of in-stent neoatherosclerosis.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | September 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subject is =18 years of age; 2. Subject has stable angina or acute coronary syndrome (including acute myocardial infarction) with evidence of coronary ischemia and de novo atherosclerotic coronary artery disease in multiple vessels with an indication for stent implantation; 3. Target lesion stenosis is = 70% (visual estimate) 4. All target lesions require treatment with stents having diameters from 2.25 mm to 4.0 mm (visual estimate) 5. Target lesion length =10 mm and =50 mm for each target lesion(s) 6. Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure; 7. Subject must be willing and able to comply with specified follow-up schedule. Exclusion Criteria: 1. Unprotected left main coronary disease; 2. Chronic total occlusion; 3. Severe calcified target lesion(s) which cannot be, in the investigator's opinion, successfully treated; 4. Significant angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment; 5. Bifurcation disease involving a side branch = 2.5 mm in diameter; 6. Restenotic lesions; 7. Target lesion(s) within a coronary bypass graft (e.g., saphenous vein or arterial graft); 8. In the Investigator's opinion, the lesion is not suitable for stenting or OCT imaging (e.g. extreme tortuosity, very distal lesions). 9. Documented left ventricular ejection fraction =30%; 10. Serum creatinine > 2.0 mg/dl at the time of treatment; 11. Recipient of heart transplant; 12. Subject with malignancies or other comorbidities (i.e. severe liver, renal, pulmonary, pancreatic disease) with life expectancy less than 18 months or that may results in protocol non-compliance; 13. Known bleeding or hyper-coagulable disorder; 14. Known allergy to stent components or any antiplatelet recommended drug 15. Planned medical or surgical procedures requiring modification of DAPT regimen within 3 months after the index procedure; 16. Women of childbearing potential without negative pregnancy test within 7 days before enrollment 17. Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | A.O. Ospedale Papa Giovanni XXIII | Bergamo |
Lead Sponsor | Collaborator |
---|---|
A.O. Ospedale Papa Giovanni XXIII |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of frames with in stent-lipid laden neointima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA) | OCT finding of neoatherosclerosis, counted as percentage of frames with in stent-lipid laden neointima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA) (18 month primary end-point) | 18 months | Yes |
Primary | length of consecutive frames with uncovered struts | OCT derived maximum length of consecutive frames with uncovered struts in the two stent arms at 3 and 18 month (3 month primary end-point and 18 months co-primary end-points) | 3 and 18 months | Yes |
Secondary | percent well apposed struts at implant without neointima | OCT derived proportion of well apposed struts at implant without neointima (% uncovered struts) at 3 and 18 months | 3 and 18 months | Yes |
Secondary | Acquired stent malapposition | Number and extent (max area-volume) of newly acquired malapposed struts at 3 and 18 months. | 3 and 18 moths | Yes |
Secondary | OCT derived abnormal intraluminal tissue | Presence of any abnormal intraluminal protruding mass at 3 and 18 months | 3 and 18 months | Yes |
Secondary | percentage OCT frames with uncovered struts | Number/percentage of OCT frames with > 30% uncovered struts at 3 and 18 months | 3 and 18 months | Yes |
Secondary | Neointimal tissue thickness | OCT calculated thickness of tissue covering stents at 3 and 18 months | 3 and 18 months | Yes |
Secondary | OCT derived percentage of frames with mature neointima | Percentage of frames with evidence of mature neointimal coverage in the two stent arms | 3 and 18 months | Yes |
Secondary | OCT derived tissue heterogeneity in neointima deposition | Segmental tissue heterogeneity in neointima deposition across the entire stent length (as assessed by OCT tissue properties parameters - including normalized intensity, attenuation, tissue contrast) at 3 and 18 months | 3 and 18 moths | Yes |
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