Comparative Optical Coherence Tomography Study - Tetrilimus vs. Xience Family of Everolimus-eluting Stents

Not Applicable

• Conditions: Health Condition 1: I209- Angina pectoris, unspecified

• Registration Number: CTRI/2018/09/015656
• Lead Sponsor: Dr Deepak Davidson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

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 <2X ULN)

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 <= 4.50 mm to be covered by same type of stent i.e., either Tetrilimus EES or Xience family of EES, in all lesions

2. Target lesion length must measure (by visual estimate) <= 40 mm

3. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >= 50% and <100%

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 <80 mm Hg and PCWP Ë?20 mm Hg or cardiac index <1.8 litres/minute/m² or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure Ë?80 mm Hg) for any time within 24 hours prior to index procedure

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 <=12 months post-index procedure

6. Cerebrovascular accident (CVA) including stroke or TIA within previous 3 months

7. Patient demonstrates evidence of leukopenia (leukocyte count <3.5 X 10â?¹/litre)

8. Patient demonstrates evidence of thrombocytopenia (platelet count <100,000/mm³) or thrombocytosis (Ë?750,000/mm³)

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of Endothelialization/Coverage <br/ ><br>Strut-level analysis: <br/ ><br>1. Proportion of covered struts <br/ ><br>2. Thickness of neointimal hyperplasia over covered struts <br/ ><br>3. Proportion of malapposed struts <br/ ><br>4. Mean malapposed strut-to-lumen distance <br/ ><br>5. Ratio of uncovered struts to total struts <br/ ><br>6. Maximum length of consecutive segments of uncovered and malapposed struts <br/ ><br>Cross-section level analysis: <br/ ><br>1. NIH area, volume <br/ ><br>2. Percent volumetric stent obstruction <br/ ><br>3. Incomplete stent apposition area and volumeTimepoint: 12 Months

Secondary Outcome Measures

Name	Time	Method
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