An observational registry study of ISAR SUMMIT coronary stent system in coronary artery diseased patients of Indian population

Active, not recruiting

• Conditions: Atherosclerotic heart disease of native coronary artery,

• Registration Number: CTRI/2022/07/044472
• Lead Sponsor: Dr Praveen Chandra

Brief Summary

It is a Prospective ,Observational, Multicentre, registry study to evaluate safety and performance of Polymer Free Everolimus Eluting Coronary Stent System In Real World Population.1000 patients will be enrollrd from 33 sites in India. The patients will be followed up till 1 year post index procedure to assess clinical status and major clinical events.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-30
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Male or female patient with age > 18 Years 2.
• Patients with coronary artery disease undergoing percutaneous coronary intervention(PCI) with ISAR Summit Polymer Free Everolimus Eluting Coronary Stent System 3.
• Patients or legal guardian who understands the study requirements and can provide informed consent in writing.

Exclusion Criteria

• Concurrent participation in another clinical trial that involves an investigational drug or device 2.
• Participant is pregnant or nursing an infant or child or planning to come pregnant while in the study 3.
• Concurrent medical condition with a life expectancy of less than 12 months 4.
• Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor, Everolimus or similar drugs,or any other analogue or derivative, cobalt, chromium or contrast media.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac Death	1 Year
Target Vessel failure related Myocardial Infarction (TV- MI)	1 Year
Clinically driven Target Lesion Revascularization (TLR)	1 Year

Secondary Outcome Measures

Name	Time	Method
Patient oriented composite (PoCE) defined as the composite of all- cause death,	any MI, any stroke and any Revascularization)

Trial Locations

Locations (31)

AMMAJI Pavani Memorial Super Speciality Hospital; 🇮🇳 Guntur, ANDHRA PRADESH, India

Apollo CVHF Heart Institute; 🇮🇳 Ahmadabad, GUJARAT, India

Arneja Heart and Multispeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Asian Institute of Gastroenterology, Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Baderia Metro Prime Multi Speciality Hospital; 🇮🇳 Jabalpur, MADHYA PRADESH, India

Capital Hospitals; 🇮🇳 Krishna, ANDHRA PRADESH, India

Care Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Caritas Hospital; 🇮🇳 Kollam, KERALA, India

CHL Multispeciality hospital & Research Centre; 🇮🇳 Chandrapur, MAHARASHTRA, India

Crescent Hospital & Heart Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

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AMMAJI Pavani Memorial Super Speciality Hospital

🇮🇳Guntur, ANDHRA PRADESH, India

Dr Sudhakar Kanumuri

Principal investigator

9618182834

mrcardio7@gmail.com