TRANSFORM OCT TRiple Assessment of Neointima Stent FOrmation to Reabsorbable polyMer With Optical Coherence Tomography

Launched by A.O. OSPEDALE PAPA GIOVANNI XXIII · Oct 24, 2013

Keywords

ClinConnect Summary

During the last decade a considerable clinical experience has been accumulated with the use of drug eluting coronary stents with durable polymers, that permanently cover the metallic stent scaffold, allowing the local delivery of anti-restenotic agents. However durable polymers have been associated with an increased risk of late and very late stent thrombosis and the anticipated development of in stent neo-atherosclerosis. Since permanent polymer coatings may have pro-inflammatory effects, with delayed healing and prolonged endothelial dysfunction, current research on DES has focused on the...

Gender

ALL

Eligibility criteria

• 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