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CTRI Number  CTRI/2025/05/087739 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A Study to Test the Safety and performance of the Eternia-AB-EveroliMus Eluting Coronary Stent SYstem (EEECSS-Eternia-AB) treatment for heart disease in Indian Patients  
Scientific Title of Study   A Prospective, MuLticenter, Clinical Study to Evaluate tHe Safety and Performance of the Eternia-AB-EveroliMus Eluting Coronary Stent SYstem (EEECSS-Eternia-AB) implanted as a part of standard clinical practice in Indian patients (ALCHEMY-AB) 
Trial Acronym  Alchemy-AB 
Secondary IDs if Any  
Secondary ID  Identifier 
CSPL/REG/2024/03 Version 1.0 Dated 06-Nov-2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pravin K Goel 
Designation  Director-Cardiology 
Affiliation  Medanta Hospital 
Address  Room No. 03 1st floor, Department of Interventional Cardiology, Medanta Hospital, Sector A, Pocket - 1, Amar Shaheed Path, Golf City, Lucknow

Lucknow
UTTAR PRADESH
226030
India 
Phone  9839015010  
Fax    
Email  golf_pgi@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravin K Goel 
Designation  Director-Cardiology 
Affiliation  Medanta Hospital 
Address  Room No. 03 1st floor, Department of Interventional Cardiology, Medanta Hospital, Sector A, Pocket - 1, Amar Shaheed Path, Golf City, Lucknow,

Lucknow
UTTAR PRADESH
226030
India 
Phone  9839015010  
Fax    
Email  golf_pgi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Priyadarshini Arambam 
Designation  Director of Operations 
Affiliation  Clicebo Solutions Private Limited 
Address  E-961, Lower Ground Floor (Basement),C.R. Park

South
DELHI
110019
India 
Phone  9910990347  
Fax    
Email  priyadarshini@clicebo.com  
 
Source of Monetary or Material Support  
Innvolution Healthcare Private Limited, Plot No. 105, Solitaire Industrial Park, Village Dahmi Kalan, Sanganer, Ajmer Road, Bagru, Jaipur-303007, Rajasthan (India)  
 
Primary Sponsor  
Name  Innvolution Healthcare Private Limited 
Address  Plot No. 105, Solitaire Industrial Park, Village Dahmi Kalan,Sangamer, Ajmer Road, Bagru, Jaipur – 303007, Rajasthan (India) 
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gautam Singal  Hero DMC Heart Institute  Tagore Nagar, Civil Lines, Ludhiana-141001, Punjab, India
Ludhiana
PUNJAB 		 9999633727

drgautamsingal@yahoo.com 
Dr Pravin K Goel  Medanta Hospital  Room No. 03 1st floor, Department of Interventional Cardiology, Medanta Hospital, Sector A, Pocket - 1, Amar Shaheed Path, Golf City, Lucknow,
Lucknow
UTTAR PRADESH 		 9839015010

golf_pgi@yahoo.co.in 
Dr Abhijeet Palshikar  Sahyadri Super Speciality Hospital  Plot No. 30-C, Erandawane, Karve Rd, Pune, Maharashtra 411004
Pune
MAHARASHTRA 		 9890336897

dr_abhijeet@yahoo.com 
Dr Richa Sharma  Shri Mahant Indiresh Hospital  Kargi - Patel Nagar Bypass, Industrial Area, Govt.Industrial Estate, Patel Nagar, Dehradun, Uttarakhand 248001
Dehradun
UTTARANCHAL 		 70545 62907

cario1richa@gmail.com 
Dr Tanuj Bhatia  Shri Mahant Indiresh Hospital  Kargi - Patel Nagar Bypass, Industrial Area, Govt.Industrial Estate, Patel Nagar, Dehradun, Uttarakhand 248001
Dehradun
UTTARANCHAL 		 9936618283

tanujclear@gmail.com 
Dr S Ramesh  Sri Ramachandra Hospital  Clinical Research Division, Dental College Basement, No. 1 Ramachandra Nagar, Porur
Chennai
TAMIL NADU 		 9940495133

sankaranramesh39@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Drug Trial Ethics Committee Dayanand Medical College and Hospital  Approved 
Institutional Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee SGRR Institute Of Medical Health Sciences IEC,  Approved 
Institutional Ethics Committee SGRR Institute Of Medical Health Sciences IEC,  Approved 
INSTITUTIONAL ETHICS COMMITTEE SRIHER SRIHER  Approved 
Redkar Hospital and Research Center IEC  Approved 
SAHYADRI HOSPITALS PRIVATE LIMITED ETHICS COMMITTEE  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. More than 18 years.
2. Males or non-pregnant females.
3. Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form.
4. Patient with coronary artery disease undergoing percutaneous coronary intervention (PCI) with Eternia-AB Everolimus Eluting Coronary Stent System only.
5. Patient with coronary artery disease having one or more de novo stenosis lesion in native coronary artery with a visually estimated diameter stenosis ≥70%.
6. Patients with Reference vessel diameter of 2.0 to 4.50 mm.
7. Patients with lesion length ≤ 52 mm.
 
 
ExclusionCriteria 
Details  1. Female patients with known pregnancy or who are lactating.
2. Patients requiring staged procedure.
3. Known congestive heart failure NYHA IV or left ventricular ejection fraction LVEF less than 40 percent.
4. Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
5. Current medical condition with a life expectancy of less than 12 months.
6. Acute Myocardial Infarction within 72 hours of Planned Index procedure.
7. Patient has current unstable arrhythmias.
8. Patients previously treated with PCI or CABG for any coronary artery lesion revascularization.
9. Patients with Chronic Total Occlusion in two or more vessels.
10. Patients with Ostial lesions within 5.0mm of vessel origin.
11. Patients with Bifurcation lesions that include a side branch greater than 2.0 mm diameter.
12. Unprotected Left Main Coronary Artery lesion.
13. Heavily calcified lesion and or calcified lesion which cannot be successfully predilated.
14. Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function serum creatinine greater than 2.0mg/dl or 150 mol/L, peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure.
15. Patients with platelet count less than 100.000 cells/cubic millimetre or greater than 700.000 cells/cubic millimetre or a WBC less than 3.000 cells/cubic millimetre. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Composite end point at 9 months follow-up indicated by Major Adverse Cardiac Events (MACE) defined as hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization.   270 days 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of DOCE
• Cardiovascular Death
• Myocardial infarction in the territory of Target vessel (TV-MI) and
• Clinically driven target lesion revascularization (CD-TLR)
 		 30 Days
180 Days
270 Days
365 Days 
Incidence of POCE
• All cause death
• Any Stroke
• Any myocardial infarction (includes non-target vessel territory)
• Any revascularization 		 30 Days
180 Days
270 Days
365 Days 
Incidence of MACE
• Cardiovascular death
• Non–fatal MI
• Target Vessel Revascularization 		 30 Days
180 Days
365 Days 
Target vessel failure (TVF)  30 Days
180 Days
270 Days
365 Days 
Non-Target Vessel related Myocardial Infarction  30 Days
180 Days
270 Days
365 Days 
Stent thrombosis as per
a. Academic Research Consortium- 2 [ARC-2] Evidence definitions – Definite and probable
b. As per latency - Acute, Subacute and late 		 a.30 Days
180 Days
270 Days
365 Days
b. Acute (0-24 hours)
Subacute (24 hours-30 days)
late (30-365 days) 
Device success:
•Residual coronary stenosis less than 20 %
•Normal coronary flow and absence of coronary dissections greater than C
•Procedural and absence of PCI complications including periprocedural MI, coronary perforation, urgent CABG or death or revascularization within 3 days of Index procedure 		 3 days 
Procedural success:
• Residual Stenosis less than 20%
• Acute Device Success as defined by Residual Stenosis 20%
• Successful reperfusion of Target vessel region with TIMI Flow 2 		 3 days 
QCA Endpoint
• Late Lumen Loss
• Angiographic binary restenosis
• In-stent and in-segment minimum lumen diameter (MLD) and % diameter stenosis (DS) 		 270 days 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
It is a prospective, multicentric clinical study to evaluate the safety and performance of Eternia-AB Everolimus Eluting Coronary Stent System implanted as a part of standard clinical practice in Indian patients
The study will include 270 patients, out of which 60 patients will be enrolled in the QCA (Quantitative Coronary Angiography) sub-study.
All patients will be followed up till 1 year after the index procedure.
 
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