| CTRI Number |
CTRI/2024/07/069702 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational registry study of Advapro Coronary Stent System in coronary artery diseased
patients of Indian and European population.
|
|
Scientific Title of Study
|
A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of The AdvaPro Sirolimus Eluting CorOnary Stent System in Coronary ARtery Stenosis in Indian and European Population. |
| Trial Acronym |
RESTORE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CSPL/PL/2023/004 Version 1.0 Dated 20-Apr-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayesh Jani |
| Designation |
Chief Medical Officer |
| Affiliation |
Advanced MedTech Solutions Private Limited |
| Address |
Clinical Research Department, P-21-22, 25-26 & 34-35, GIDC Manjusar, Tal. – Savli,
Vadodara
GUJARAT
391775
India |
| Phone |
8130009876 |
| Fax |
|
| Email |
jjani@amsltd.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Jani |
| Designation |
Chief Medical Officer |
| Affiliation |
Advanced MedTech Solutions Private Limited |
| Address |
Clinical Research Department, P-21-22, 25-26 & 34-35, GIDC Manjusar, Tal. – Savli,
Vadodara
GUJARAT
391775
India |
| Phone |
8130009876 |
| Fax |
|
| Email |
jjani@amsltd.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyadarshini Arambam |
| Designation |
Director of Operations |
| Affiliation |
Clicebo Solutions Private Limited |
| Address |
Room no.- 04, Clinical Operations, E-961,Lower Ground Floor, C.R. Park, New Delhi-110019
New Delhi
DELHI
110019
India |
| Phone |
9910990347 |
| Fax |
|
| Email |
priyadarshini@clicebo.com |
|
|
Source of Monetary or Material Support
|
| Advanced MedTech Solutions Private Limited, P-21-22, 25-26 & 34-35, GIDC Manjusar, Tal. – Savli, Vadodara, Gujarat, India, 391775 |
|
|
Primary Sponsor
|
| Name |
Advanced MedTech Solutions Private Limited |
| Address |
P-21-22, 25-26 & 34-35, GIDC Manjusar, Tal. – Savli, Dist. – Vadodara- 391775, Gujarat, India
|
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
France
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SK Sinha |
LPS Institute of cardiology and Cardiac surgery |
Room No. 13 3rd floor, Department of Cardiology, GSVM Medical College, Swaroop Nagar
Kanpur Dehat
UTTAR PRADESH |
9670220088
fionasan@rediffmail.com |
| Dr Yash Paul Sharma |
PGIMER |
Department of
Advanced Cardiac
Center PGIMER
Chandigarh-160012
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
9417167214
ypspgi@gmail.com |
| Dr Arun Kalyanasundaram |
Promed Hospital |
1, 10A, Raja Garden, Kottivakkam, Chennai 600041
Chennai
TAMIL NADU |
7550074655
arunksundaram@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE |
Approved |
| Institutional Ethics Committee |
Approved |
| Ripon Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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. Greater than 18 years.
2. All (Males, Females, Transgenders, Non-binary).
3. Patient or legally authorized representative
(LAR) agrees to participation by signing the
informed consent form.
4. Patient with coronary artery disease Eligible
for percutaneous coronary intervention (PCI).
5. Patient with coronary artery disease having one
or more de novo stenosis lesion in two native
coronary artery with a visually estimated diameter
stenosis greater than or equal 70 percent.
6. Patients with Reference vessel diameter of 2.5
to 3.50 mm.
7. Patients with lesion length less than or equal 36 mm. |
|
| ExclusionCriteria |
| Details |
1 Ethical- Pregnant and lactating females
2 Condition- Patients requiring staged procedure
3 Condition- Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 percent
4 Condition- Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media
5 Condition- Current medical condition with a life expectancy of less than 12 months
6 Condition- Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure
7 Condition- Patient has current unstable arrhythmias
8 Procedural- Patients previously treated with PCI or CABG for any coronary artery lesion revascularization
9 Procedural- Patients with Chronic Total Occlusion in two or more vessels
10 Procedural- Patients with Ostial lesions (within 5mm of vessel origin).
11 Procedural- Patients with Bifurcation lesions that include a side branch greater than 2 mm diameter
12 Procedural- Unprotected Left Main Coronary Artery lesion
13 Condition- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist
14 Condition- 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 mg per dl or 150 µmol per L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure
15 Condition- Patients with platelet count less than 100 cells per mm3 or greater than 700 cells per mm3 or a WBC less than 3 cells per mm3
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Composite Endpoint
MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization) |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of DOCE
Cardiovascular Death
Myocardial infarction in the territory of Target vessel
Clinically driven target lesion revascularization |
30 Days, 180 Days, 270 Days & 360 days |
Incidence of POCE
All cause death
Any Stroke
Any myocardial infarction
Any revascularization |
30 Days, 180 Days, 270 Days & 360 days |
Incidence of MACE
Cardiovascular Death
Non-fatal MI
Target Vessel Revascularization |
30 Days, 180 Days & 360 days |
| Target vessel failure (TVF) |
30 Days, 180 Days, 270 Days and 360 days |
| Non-Target Vessel related Myocardial Infarction |
30 Days, 180 Days, 270 Days and 360 days |
Stent thrombosis
Stent thrombosis as per
Academic Research Consortium [ARC] Evidence definitions – Definite & probable
As per latency - Acute (0-24 hours), Subacute (24 hours-30 days) & late (30-365 days) |
0-24 hours, 24 hours-30 days & late 30-365 days |
Device success
Residual coronary stenosis less than 20 percent
Normal coronary flow & absence of coronary dissections greater than C
Procedural & absence of PCI complications including periprocedural MI, coronaryperforation, urgent CABG or death or revascularization within 3 days of Index procedure |
0 hour, 24 hours, 3 days |
Procedural Success
Residual Stenosis less than 20 percent
Successful reperfusion of Target vessel region with TIMI Flow greater than or equal 2 |
During & after the procedure |
Acute Device Success
Acute Device Success as defined by Residual Stenosis less than or equal 20 percent |
During and after the procedure |
For QCA Group
Late Lumen Loss
Angiographic binary restenosis
In-stent & in-segment minimum lumen diameter (MLD) & percent diameter stenosis (DS) |
270 Days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="80"
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)
|
10/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/07/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| 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
|
An Observational Registry Study of Advapro Coronary Stent System in Coronary Artery Diseased Patients of Indian and European Population.
The study will include 120 patients, out of which 80 patients will be enrolled in India and 40 patients will be enrolled in Europe. A QCA Analysis will be performed on minimum 48 patients in Indian population only.
All patients will be followed up till 1 year after the index procedure.
Primary Objective: - To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.
Secondary Objectives: - To estimate patient safety and performance through incidence of Major Adverse Cardiac Events (MACE) at 30, 180, 360 days.
- To Estimate Definitive parameters of performance of AdvaPro Sirolimus Eluting Stent as defined by Late Lumen Loss and Diameter Stenosis percentage at 270 days of AdvaPro Sirolimus Eluting Stent.
|