Health Condition 1: I209- Angina pectoris, unspecified
Conditions
Interventions
Intervention1: Tetrilimus Everolimus-eluting Stent: Tetrilimus everolimus-eluting stent is a combination product comprised of two components, a device (Tetrinium coronary stent system as a platform) a
Sponsors
Dr Deepak Davidson
Eligibility
Inclusion criteria
Inclusion criteria: General Inclusion Criteria: 1. Patient is >=18 years of age 2. Patient is eligible for percutaneous coronary intervention (PCI) 3. Patient has documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or documented silent ischemia or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C) 4. Patient demonstrates evidence of an ongoing acute myocardial infarction (eg. STEMI or enzyme elevation CKË?2X local laboratoryâ??s ULN unless CK-MB is 5. Patient demonstrates a left ventricular ejection fraction (LVEF) of >=40% as measured prior to enrollment 6. Tetrilimus EES (alone) / Xience family of EES (alone) is/are to be implanted into the coronary vasculature during the index procedure 7. Patient understands and agrees to comply with all specified study requirements and provides written Informed Consent to this effect Angiographic Inclusion Criteria: 1. Up to 2 de novo lesions in separate coronary vessels with a visually estimated reference vessel diameter (RVD) >= 2.75 mm and 2. Target lesion length must measure (by visual estimate) 3. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >= 50% and <100%
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. The patient has a life expectancy of less than 12 months due to another medical condition 2. Patient has a history of hypersensitivity to everolimus or structurally related compounds 3. Patient exhibits cardiogenic shock (systolic pressure 4. Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine Ë?2.0 mg/dl or 177 μmol/l) 5. Planned cardiac surgery procedure 6. Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months 7. Patient demonstrates evidence of leukopenia (leukocyte count 8. Patient demonstrates evidence of thrombocytopenia (platelet count 9. Patient is contraindicated to Aspirin (successful prior desensitization to aspirin is not an exclusion), clopidogrel, or prasugrel or ticagrelor 10. Patient is currently on warfarin, or possibility of treatment with warfarin during the following 12 months post index procedure 11. Patient has been treated with everolimus or other chemotherapeutic agents within 12 months prior to planned index procedure 12. Known allergy to cobalt chromium (Co-Cr) 13. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure 14. Patient that in the opinion of the investigator is not clinically appropriate for OCT evaluation Angiographic Exclusion Criteria: 1. Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified, by visual estimate 2. Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a Ë?60 degree bend in the vessel 3. Study lesion involving bifurcation with a side branch larger than 2.0 mm in diameter 4. Arterial or saphenous vein graft lesions or lesions distal to a diseased arterial or saphenous vein graft 5. Previous treatment of the target lesion (excluding pre-dilation) with another interventional device 6. A target lesion with in-stent restenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of Endothelialization/Coverage Strut-level analysis: 1. Proportion of covered struts 2. Thickness of neointimal hyperplasia over covered struts 3. Proportion of malapposed struts 4. Mean malapposed strut-to-lumen distance 5. Ratio of uncovered struts to total struts 6. Maximum length of consecutive segments of uncovered and malapposed struts Cross-section level analysis: 1. NIH area, volume 2. Percent volumetric stent obstruction 3. Incomplete stent apposition area and volumeTimepoint: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT finding of neoatherosclerosis: OCT finding of neoatherosclerosis, counted as percentage of frames with in-stent lipid laden neo-intima, neovascularization, calcification and thin-cap fibro-atheroma (TFCA)Timepoint: 12 Months | — |
Countries
India
Contacts
Public ContactDr Deepak Davidson
Caritas Hospital
Outcome results
None listed