An observational registry study on the use of ENCRUSO RAL- Everolimus eluting stent in indian population
- Conditions
- Atherosclerotic heart disease of native coronary artery,
- Registration Number
- CTRI/2022/03/040921
- Lead Sponsor
- Nano Therapeutics Private Limited
- Brief Summary
It is a prospective, multi-center, non-randomized, registry study with clinical follow up to be conducted at 30 days, 180 days, year 1 and year 2 post index procedure. 500 patients to receive treatment with the Encruso RAL-Everolimus Eluting Coronary Stent.The primary objective of the study is to evaluate the safety and efficacy of the Encruso RAL-Everolimus eluting coronary stent system implanted during routine clinical practice in India at 1 year follow up. 50 patients out of 500 will be included in the OCT sub study. The primary objective of the study is to evaluate the malapposition, degree of strut coverage and vessel wall response after implantation of Encruso RAL-Everolimus Eluting Coronary Stent by Optical Coherence Tomography at 6 months angiographic follow up. The sub study is designed to run seamlessly with the main study but sites can opt out if they choose not to participate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 500
1.Male or female patient who is 18 years and above 2.Patients undergoing percutaneous coronary intervention with Encruso RAL-Everolimus Eluting Coronary Stent System 3.Patient or legal guardian understands the study requirements and provides written informed consent 4.Patient who is on dual antiplatelet therapy for at least 6 months post procedure.
1.Patient has known hypersensitivity or allergies to Aspirin, Heparin,Clopidogrel, Ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, or contrast media 2.Patient with life expectancy less than 2 years 3.Pregnant and lactating females or planning to become pregnant while in the study 4.Patient currently participating in another investigational drug or device clinical trial.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method and 1 year | OCT sub study: 6 month OCT sub study: 1 year | OCT sub study: 6 month Clinically driven Target Lesion Revascularization 1 year | OCT sub study: 6 month Strut-level analysis 1 year | OCT sub study: 6 month Proportion of covered struts 1 year | OCT sub study: 6 month o Thickness of neointimal hyperplasia (NIH) over 1 year | OCT sub study: 6 month covered struts 1 year | OCT sub study: 6 month Proportion of malapposed struts 1 year | OCT sub study: 6 month Mean malapposed strut to lumen distance 1 year | OCT sub study: 6 month Ratio of uncovered struts to total struts 1 year | OCT sub study: 6 month Target Lesion Failure (TLF) rate 1 year | OCT sub study: 6 month A composite endpoint of Cardiac Death 1 year | OCT sub study: 6 month Target Vessel related Myocardial Infarction (MI) 1 year | OCT sub study: 6 month (TLR) at 1 year follow-up 1 year | OCT sub study: 6 month Maximum length of consecutive segments of uncovered and malapposed struts 1 year | OCT sub study: 6 month Cross-section level analysis: 1 year | OCT sub study: 6 month NIH area, volume 1 year | OCT sub study: 6 month Percent volumetric stent obstruction 1 year | OCT sub study: 6 month Incomplete stent apposition (ISA) area and volume 1 year | OCT sub study: 6 month
- Secondary Outcome Measures
Name Time Method Target Vessel Failure (TVF) rate ID-TVR Procedural endpoints: Device success (residual coronary stenosis less than 50 %, normal coronary flow and absence of coronary dissection) OCT SUB STUDY: Angiographic Endpoint:
Trial Locations
- Locations (18)
Apollo CVHF Heart Institute
🇮🇳Ahmadabad, GUJARAT, India
B M Birla Heart Research Centre
🇮🇳Kolkata, WEST BENGAL, India
Batra Hospital and Medical Research Centre
🇮🇳Delhi, DELHI, India
Dr. Ramesh Cardiac and Multispecialty Hospital Pvt Ltd Pvt. Ltd
🇮🇳Krishna, ANDHRA PRADESH, India
HEALTHWORLD HOSPITALS
🇮🇳Barddhaman, WEST BENGAL, India
Justice K S Hegde Charitable Hospital
🇮🇳Kannada, KARNATAKA, India
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
LPS Institute of cardiology and Cardiac surgery
🇮🇳Dehat, UTTAR PRADESH, India
Maharaja Agrasen Hospital
🇮🇳West, DELHI, India
Marengo QRG Hospital
🇮🇳Faridabad, HARYANA, India
Scroll for more (8 remaining)Apollo CVHF Heart Institute🇮🇳Ahmadabad, GUJARAT, IndiaDr Sameer I DaniPrincipal investigator9825038855drsameerdani@yahoo.com