CTRI/2022/07/044472 [Registered on: 29/07/2022] Trial Registered Prospectively
Last Modified On:
28/02/2025
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Registry
Study Design
Single Arm Study
Public Title of Study
An observational registry study of ISAR SUMMIT coronary stent system in coronary artery diseased patients of Indian population
Scientific Title of Study
A prospective, open-labelled, multicentre, observational registry of ISAR SUMMIT in CAD patients undergoing PCI in real world indian population (TRANSEVER REGISTRY)
A unit of Apollo CVHF Limited , Department Of Cardiology ,Opp. GNFC Tower , Pakwan Cross Road , S.G. Highway, Bodakdeb, Ahemdabad-380059 Ahmadabad GUJARAT
9825038855
drsameerdani@yahoo.com
Dr Jaspal Arneja
Arneja Heart and Multispeciality Hospital
Plot No 123, Behind Somalwar High School, Ramdaspeth, Nagpur, Maharashtra 440010 Nagpur MAHARASHTRA
9823066007
jaspalarneja_200@yahoo.com
Dr Anuj Kapadia
Asian Institute of Gastroenterology, Hospitals
 No 136, Plot No 2/3/4/5 Survey, 1, Mindspace Rd, Gachibowli, Hyderabad, Telangana 500032
Hyderabad TELANGANA
9959977991
anuj914@yahoo.co.in
Dr Amjad Ali
Baderia Metro Prime Multi Speciality Hospital
Bus stand, kuchaini parisar, Damoh Naka, Nr Kchetriya, Transport Nagar, Jabalpur, Madhya Pradesh 482002 Jabalpur MADHYA PRADESH
8904637858
drmz2007@gmail.com
Dr Dileep Kumar Tiwari
Baderia Metro Prime Multi Speciality Hospital
Bus stand, kuchaini parisar, Damoh Naka, Nr Kchetriya, Transport Nagar, Jabalpur, Madhya Pradesh 482002 Jabalpur MADHYA PRADESH
A unit of Eternal Heart care centre and Research Institute Pvt.Ltd. 3A, Jagatpura Rd, near Jawahar Circle, Chainpura, Malviya Nagar, Jaipur, Rajasthan 302017 Jaipur RAJASTHAN
Sir Ganga Ram Hospital Ethics Committee, Dr Ashwani Mehta
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,
Intervention / Comparator Agent
Type
Name
Details
Intervention
NIL
NIL
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. 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
ExclusionCriteria
Details
1. 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
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Cardiac Death
Target Vessel failure related Myocardial Infarction (TV- MI)
Clinically driven Target Lesion Revascularization (TLR)
1 Year
Secondary Outcome
Outcome
TimePoints
Patient oriented composite (PoCE) defined as the composite of all- cause death,
any MI, any stroke and any Revascularization)
Cardiac Death
Target Vessel failure related Myocardial Infarction (TV- MI)
Clinically driven Target Lesion Revascularization (TLR)
Definite/Probable Stent Thrombosis (defined by Academic Consortium (ARC) criteria
Procedural Endpoints
Device success
Residual coronary stenosis 50%, normal coronary flow and absence of coronary dissection
30 days, 180 days, and 1 year post-index procedure
Total Sample Size="1000" Sample Size from India="1000" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
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.