| CTRI Number |
CTRI/2025/09/095273 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A European Study on Techniques for Treating Artery Blockages in Patients with Heart Attacks ROCA STEMI |
|
Scientific Title of Study
|
European Registry On Plaque ModifiCAtion in the STEMI Population (ROCA-STEMI) |
| Trial Acronym |
ROCA-STEMI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT05752617 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarita Rao |
| Designation |
Senior Interventional Cardiologist and Director Cathlab |
| Affiliation |
|
| Address |
Department of Cardiology 5th floor Apollo Rajshree Hospitals Sector-D Scheme No 74C Vijay Nagar Indore Madhya Pradesh 452010
Indore
MADHYA PRADESH
452010
India |
| Phone |
8959907706 |
| Fax |
|
| Email |
saritarosh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshan Rao |
| Designation |
Senior Interventional Cardiologist and Head |
| Affiliation |
|
| Address |
Department of Cardiology 5th floor Apollo Rajshree Hospitals Sector-D Scheme No 74C Vijay Nagar Indore Madhya Pradesh 452010
Indore
MADHYA PRADESH
452010
India |
| Phone |
8959907707 |
| Fax |
|
| Email |
drroshanrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Achukatla Kumar |
| Designation |
Senior Research Consultant |
| Affiliation |
|
| Address |
Department of Cardiology 5th floor Apollo Rajshree Hospitals Sector-D Scheme No 74C Vijay Nagar Indore Madhya Pradesh 452010
Indore
MADHYA PRADESH
452010
India |
| Phone |
8247219324 |
| Fax |
|
| Email |
dr.achukatlakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Rajshree Hospitals Sector-D Scheme No 74C Vijay Nagar Indore Madhya Pradesh 452010 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Germany
Hungary
Italy
Poland
Spain
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Achukatla Kumar |
Apollo Rajshree Hospitals Indore |
Sector-D, Scheme No 74C, Vijay Nagar, Indore, Madhya Pradesh 452010
Indore
MADHYA PRADESH |
8247219324
dr.achukatlakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Apollo Rajshree Hospitals Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I220||Subsequent ST elevation (STEMI) myocardial infarction of anterior wall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of STEMI
Undergoing primary PCI
De novo culprit lesion in a native coronary artery
Severe calcification of the target lesion or equivalent balloon uncrossable or undilatable lesion
Use of a plaque modification device to treat the culprit lesion
Signed written informed consent by the patient or their legal representative |
|
| ExclusionCriteria |
| Details |
The target vessel had a stent from a previous PCI
The target lesion was treated as a staged procedure
Pregnant women
Terminally ill patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Target Vessel Failure The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cardiac death Death that could not be attributed to a noncardiac etiology was considered cardiac death
Major Adverse Cardiac Events MACE Major Adverse Cardiac Events MACE at 12 months death re-infarction acute cardiovascular disease hemorrhagy and or stent thrombosis
Target vessel revascularization Target vessel revascularization was defined as repeated revascularization by PCI or surgery of the target vessel
Target lesion revascularization Target lesion revascularization was defined as any revascularization procedure performed at the site of the treated lesion associated with clinical and or objective evidence of inducible myocardial ischemia |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="50"
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)
|
07/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is an European prospective cohort study from February 2023 until February 2026 The investigators want to analyze the clinical success, efficacy and safety of consecutive patients who presented with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention for de novo heavily calcified culprit lesion using plaque modification devices before stent implantation |