| CTRI Number |
CTRI/2025/10/096100 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study Comparing the Long term Results of Two Heart Stents Sirolimus and Everolimus. |
|
Scientific Title of Study
|
Long term Comparative Outcomes of Sirolimus versus Everolimus Eluting Coronary Stents A Single Centre Ambispective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DualDES_V1.0.0_16-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suresh Kumar Paidi |
| Designation |
Consultant cardiologist |
| Affiliation |
Anil Neerukonda Hospital |
| Address |
Department of Cardiology, Ground Floor
Anil Neerukonda Hospital Opposite: Three polamamba temple,Sangivalasa,Tagurapuvalasa, Visakhapatnam, Andra Pradesh,India.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9866311341 |
| Fax |
|
| Email |
kumar.has.suresh55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tahir Khan |
| Designation |
Research Scholar |
| Affiliation |
Rajju Shroff Rofel university |
| Address |
Department of Pharmacology, Rajju Shroff Rofel University
Rajju Shroff Rofel University, Vapi, Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
9033477636 |
| Fax |
|
| Email |
khantahir126@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Kumar Paidi |
| Designation |
Consultant cardiologist |
| Affiliation |
Anil Neerukonda Hospital |
| Address |
Department of Cardiology, Ground Floor
Anil Neerukonda Hospital Opposite: Three polamamba temple,Sangivalasa,Tagurapuvalasa, Visakhapatnam, Andra Pradesh,India.
ANDHRA PRADESH
531162
India |
| Phone |
9866311341 |
| Fax |
|
| Email |
kumar.has.suresh55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Hospital, Opposite: Three polamamba temple,Sangivalasa,Tagurapuvalasa, Visakhapatnam, Andhra Pradesh 531162, India. |
|
|
Primary Sponsor
|
| Name |
Anil Neerukonda Hospital |
| Address |
Anil Neerukonda Hospital Opposite: Three polamamba temple,Sangivalasa,Tagurapuvalasa, Visakhapatnam, Andhra 531162 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suresh Kumar Paidi |
Anil Neerukonda Hospital |
Department of Cardiology, Ground Floor
Anil Neerukonda Hospital Opposite: Three polamamba temple,Sangivalasa,Tagurapuvalasa, Visakhapatnam, Andra Pradesh,India.
Visakhapatnam
ANDHRA PRADESH |
09866311341
kumar.has.suresh55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NRI INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have been treated with a Sirolimus- or Everolimus-Eluting Coronary Stent System and have completed a minimum of 1-year follow-up.
Participants who are willing to comply with study-related follow-up requirements. |
|
| ExclusionCriteria |
| Details |
Patients who have not been treated with a Sirolimus- or Everolimus-Eluting Coronary Stent System or have not completed a minimum of 1-year follow-up.
Participants who are unwilling to comply with study-related follow-up requirements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Major Adverse Cardiac Events
2. Target Lesion Failure |
1. Time Frame: Baseline, post-procedure, Through 1 year, 6 month ± 15 days
2. Time Frame: Baseline, post-procedure, Through 1 year, 6 month ± 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Target vessel failure
2. Quality of Life (QoL) questionnaire
3. All mortality rate
4. Non-Cardiac adverse events
5. Device and procedural Success |
1. Time Frame: Baseline, post-procedure, Through 1 year, 6 month ± 15 days
2. Time Frame: through 1 year, 6 month ± 15 days
3. Time Frame: Baseline, post-procedure, Through 1 year, 6 month ± 15 days
4. Time Frame: Baseline, post-procedure, Through 1 year, 6 month ± 15 days
5. Time Frame:Intra- Operative, Post-Procedure |
|
Target Sample Size
Modification(s)
|
Total Sample Size="151"
Sample Size from India="151"
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)
|
29/10/2025 |
| 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="1"
Months="6"
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
|
Study Title: DualDES: Long-term Comparative Outcomes of Sirolimus- versus Everolimus-Eluting Coronary Stents A Single-Centre Ambispective Study Study Design: A Real-World Evidence, Single-center, Observational, ambispective study. Study Objective: This study aims to evaluate and compare the long-term safety, performance, and clinical outcomes of Sirolimus- versus Everolimus-eluting coronary stent systems in real-world patients with native coronary artery disease. Rationale of the study: Drug-eluting stents (DES) have significantly improved the treatment of coronary artery disease (CAD) by reducing the incidence of restenosis, neointimal hyperplasia, and the need for repeat revascularization compared to bare-metal stents. Among the widely used DES, sirolimus- and everolimus-eluting stents utilize potent antiproliferative agents that inhibit smooth muscle cell proliferation and migration key contributors to restenosis. Both sirolimus and everolimus belong to the mTOR inhibitor class and are locally delivered at the site of the coronary lesion through polymer-coated stents. This targeted delivery maximizes efficacy at the lesion site while minimizing systemic drug exposure and related adverse effects. Although both agents share a similar mechanism of action, subtle differences in pharmacokinetics, stent design, polymer composition, and drug-release kinetics may influence their long-term clinical performance and safety profiles. This study aims to generate real-world, comparative evidence on the long-term safety, performance, and clinical outcomes associated with sirolimus- versus everolimus-eluting coronary stents in patients undergoing percutaneous coronary intervention |