| CTRI Number |
CTRI/2024/10/075690 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Registry for Mozecâ„¢ SEB: Evaluating Treatment for Coronary Artery Disease |
|
Scientific Title of Study
|
A prospective, single-centre, single-arm registry to evaluate short and mid-term
experience of Mozecâ„¢ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter in patients with
coronary artery disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankur Phatarpekar |
| Designation |
Interventional Cardiologist |
| Affiliation |
Symbiosis Speciality Hospital |
| Address |
Symbiosis Speciality Hospital , FITHEALTH Hospital LLP
Department of Cardiology
12th Floor Diamond plaza medical centre, Opp Plaza theatre, Chabildas road, Dadar west, Mumbai 400028
Mumbai
MAHARASHTRA
400028
India |
| Phone |
|
| Fax |
|
| Email |
drankurmd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankur Phatarpekar |
| Designation |
Interventional Cardiologist |
| Affiliation |
Symbiosis Speciality Hospital |
| Address |
Symbiosis Speciality Hospital , FITHEALTH Hospital LLP
Department of Cardiology
12th Floor
Diamond plaza medical centre, Opp Plaza theatre, Chabildas road, Dadar west, Mumbai 400028
Mumbai
MAHARASHTRA
400028
India |
| Phone |
9820384743 |
| Fax |
|
| Email |
drankurmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankur Phatarpekar |
| Designation |
Interventional Cardiologist |
| Affiliation |
Symbiosis Speciality Hospital |
| Address |
Symbiosis Speciality Hospital , FITHEALTH Hospital LLP
Department of Cardiology
12th Floor
Diamond plaza medical centre, Opp Plaza theatre, Chabildas road, Dadar west, Mumbai 400028
MAHARASHTRA
400028
India |
| Phone |
9820384743 |
| Fax |
|
| Email |
drankurmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Symbiosis Speciality Hospital, Diamond plaza medical centre, 4th floor doctor house, opp. Plaza theatre, Chabildas road, Dadar west, Mumbai 400028 |
|
|
Primary Sponsor
|
| Name |
Symbiosis Speciality Hospital |
| Address |
Diamond plaza medical centre, 4th floor doctor house, opp. Plaza theatre, Chabildas road, Dadar west, Mumbai 400028 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ankur Phatarpekar |
Symbiosis Speciality Hospital |
Symbiosis Speciality Hospital , FITHEALTH Hospital LLP
Department of Cardiology
12th Floor
Diamond plaza medical centre, Opp Plaza theatre, Chabildas road, Dadar west, Mumbai 400028
Mumbai
MAHARASHTRA |
9820384743
drankurmd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Adroit Ethics Committee |
Approved |
| Adroit Ethics Committee |
Approved |
| Adroit Ethics Committee |
Approved |
| Adroit Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I248||Other forms of acute ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged ≥18 years
Patients with coronary artery lesions (de-novo, In-stent restenosis and high-bleeding risk [HBR])) eligible for treatment using Mozec SEB as per investigator’s discretion.
Patient has given written informed consent for participation prior to enrolment
Patient is willing to undergo all study procedures and follow-up requirements.
|
|
| ExclusionCriteria |
| Details |
Hypersensitivity or allergy to aspirin, heparin, clopidogrel, bivalirudin, ticlopidine, prasugrel, ticagrelor and drug such as Sirolimus or with any contrast media.Patient in whom anti-platelet and/or anti-coagulant therapy are contraindicated.Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon. Transplant patient.Patients with low ejection fraction. Patients with vascular aneurysms.Lesion located in left main coronary artery. Aorto-ostial location (within 3 mm). Patients with chronic total occlusions.
Patients with severely calcified vessels and angulations.
Pregnant or lactating female.
Any condition, which in the treating surgeon’s opinion would preclude safe participation of patient in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Major Adverse Cardiovascular Events (MACE) [Time Frame: 12 months]
Defined as the composite of cardiac death, target vessel Myocardial infarction (TV-MI), and target lesion revascularization (TLR). |
Time Frame: 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiovascular death |
Time Frame: 1 month, 6 months, 12 months |
| Target Vessel Myocardial Infarction |
Time Frame: 1 month, 6 months, 12
months |
| Target Vessel Revascularization (TVR) |
Time Frame: 1 month, 6 months, 12
months |
| Target Lesion Revascularization (TLR) |
[Time Frame: 1 month, 6 months, 12
months |
| Restenosis |
Time Frame: 12 months |
| Quality of Life (QoL) |
Time Frame: Baseline, 1 month, 6 months, 12 months |
| Procedure success |
Time Frame: Discharge |
| Device success |
Time Frame: During procedure |
| Length of Hospital Stay |
Time Frame: at Discharge |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
07/11/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Percutaneous coronary intervention (PCI) often with the implantation of a stent is considered standard
revascularization treatment of flow-limiting coronary stenosis. The first introduced stent was a bare
metal stent (BMS) to reduce restenosis of the treated segment by balloon angioplasty. However,
restenosis from neointimal hyperplasia in the stented area, known as in-stent restenosis, remained a
complication of BMS[17]
. By combining the mechanical balloon dilatation of the vessel with local delivery
of antiproliferative medicine, introduction of the drug-eluting stent (DES) reduced the incidence of instent restenosis. However, DESs imply other limitations, including increased bleeding risks associated
with the need for prolonged dual antiplatelet therapy (DAPT) and the risk of late and very late stent
thrombosis (ST)[9,10]
.
Therefore, current study aims to collect real-world data of Mozecâ„¢ SEB Sirolimus Eluting Rx PTCA
Balloon Dilatation Catheter in patients with coronary artery disease. |