| CTRI Number |
CTRI/2025/04/084357 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study aims to evaluate the safety of the MANTA® Vascular Closure Device in patients in India. |
|
Scientific Title of Study
|
Prospective clinical study evaluating contemporary MANTA® safety outcomes in India (MANTA® Safety Study in India) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ST3809 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Davidson |
| Designation |
Chief Interventional Cardiologist |
| Affiliation |
Caritas Hospital & Institute of Health Sciences |
| Address |
Caritas Hospital & Institute of Health Sciences,
Kottayam, Kerala
Kottayam
KERALA
686630
India |
| Phone |
|
| Fax |
|
| Email |
deepakdavidson@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth S Prakash |
| Designation |
Manager, Clinical and Medical affairs. |
| Affiliation |
Teleflex Medical India Pvt Limited |
| Address |
Teleflex Medical India Pvt Ltd, M/S Smartwork co working space,
Golden Millenium, 1st floor 69/3, 44 Millers Rd, Vasanth Nagar,Bengaluru
Bangalore
KARNATAKA
560052
India |
| Phone |
9964566700 |
| Fax |
|
| Email |
prashanth.srirangapattanaprakash@teleflex.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth S Prakash |
| Designation |
Manager, Clinical and Medical affairs. |
| Affiliation |
Teleflex Medical India Pvt Limited |
| Address |
Teleflex Medical India Pvt Ltd, M/S Smartwork co working space,
Golden Millenium, 1st floor 69/3, 44 Millers Rd, Vasanth Nagar,Bengaluru
Bangalore
KARNATAKA
560052
India |
| Phone |
9964566700 |
| Fax |
|
| Email |
prashanth.srirangapattanaprakash@teleflex.com |
|
|
Source of Monetary or Material Support
|
| Teleflex Medical India Pvt Ltd, M/S Smartwork co working space, Golden Millenium, 1st floor
69/3, 44 Millers Rd, Vasanth Nagar, Bengaluru - 560052 |
|
|
Primary Sponsor
|
| Name |
Teleflex Medical India Private Limited |
| Address |
Smartworks Coworking Space, Golden Millenium, 1st Floor 69/3, 44
Millers Rd, Vasanth Nagar, Bengaluru, Karnataka - 560052, India |
| Type of Sponsor |
Other [Medical Device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Davidson |
Caritas Hospital & Institute of Health Sciences |
Department of Interventional Cardiology, Ground Floor, Thellakom (PO), Kottayam, Kerala, 686630
Kottayam
KERALA
Kottayam
KERALA |
9447216959
deepakdavidson@yahoo.com |
| Dr John Jose |
CMC Vellore Ranipet Campus |
Cardiology Unit-2, CMC Vellore Ranipet Campus, Kannigapuram
Vellore
TAMIL NADU |
9843593721
drjohnjose@gmail.com |
| Dr Ashok Seth |
Fortis Escorts Heart Institute |
Okhla Road Sukhdev Vihar Metro Station, New Delhi, Delhi
New Delhi
DELHI |
9810025814
ashok.seth@fortishealthcare.com |
| Dr Balbir singh |
Max Superspeciality Hospital |
Press Enclave Road, New Delhi, Delhi
New Delhi
DELHI |
9810842890
balbir.singh1@maxhealthcare.com |
| Dr Praveen Chandra |
Medanta- The Medicity |
CH Baktawar Singh Road, Islampur colony, Sector 38, Gurugram, Haryana
Gurgaon
HARYANA |
9810125370
praveen.chandra@medanta.org |
| Dr Rajneesh Kapoor |
Medanta- The Medicity |
CH Baktawar Singh Road, Islampur colony, Sector 38, Gurugram, Haryana
Gurgaon
HARYANA |
9971991740
rajneesh.kapoor@medanta.org |
| Dr Virendra sheorain |
Medanta- The Medicity |
H Baktawar Singh Road, Islampur colony, Sector 38, Gurugram, Haryana
Gurgaon
HARYANA |
9868887666
virender.sheorain@medanta.org |
| Dr Asish Kumar Mandalay |
MyHart at Starcare Hospital |
MyHart at Starcare Hospital, N H Bypass Junction, near Thondayad, Kozhicode, Kerala 673017
Kozhikode
KERALA |
9895443390
asishmandalay@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| DiabcareIndia |
Approved |
| Ethics Committee-Caritas Hospital |
Approved |
| Institutional Ethics Committee Devki Devi Foundation, Max Super Speciality Hospital |
Approved |
| Institutional Ethics Committee Fortis Escorts Heart Institute |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I350||Nonrheumatic aortic (valve) stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Non-interventional Study |
| Comparator Agent |
NIL |
Non-interventional study |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Candidate meets criteria for on-label use of
MANTA® VCD as specified in MANTA® VCD Instructions for Use (IFU), as per judgement of the investigator.
2.Age 21 years & above. |
|
| ExclusionCriteria |
| Details |
Before the procedure-
1.Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.
2.Severe calcification of the access vessel.
3.Severe peripheral artery disease.
4.Marked tortuosity of the femoral or iliac artery.
5.Patients who cannot be anti-coagulated for
the procedure
6.Marked obesity or cachexia (BMI above 40 or
below 20).
During the TAVR/EVAR/TEVAR procedure-
7.Puncture in the origin of the profundal femoral artery, above the inguinal ligament, or above the most inferior border of the epigastric artery (IEA).
8.Sheath insertion in the vessel other than the
femoral artery.
9.Blood Pressure above 180 mmHg. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VCD Large Bore Access-site Related VARC-3 Major & Minor Vascular complications through discharge following TAVR/EVAR/TEVAR procedure (adapted from VARC-3 Criteria 1). |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Additional interventions required at large bore access site to address bleeding or other large bore access site complications (e.g., bare, or
covered stent, or surgical repair) through discharge following TAVR/EVAR/TEVAR
procedure, reported by Investigators.
|
1 Month |
VCD Large Bore Access-site Related VARC- 3 Major & Minor Vascular complications within 30 days of TAVR/EVAR/TEVAR
procedure (adapted from VARC-3 Criteria1); reported by Investigators. |
1 Month |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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)
|
16/04/2025 |
| 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="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
|
This is a prospective, multicentre, observational, single-arm
study to examine and collect data on safety outcomes of MANTA® large bore
closure device in patients undergoing standard of care (SOC) Transcatheter
aortic valve replacement (TAVR)/ Endovascular aneurysm repair (EVAR)/ Thoracic
Endovascular Aortic Repair (TEVAR) procedures in femoral arterial access sites
in India. The patients will be followed up for a period of 1 month. The primary
objective is to estimate the percentage of subjects with one or more VARC-3 major and minor vascular complications through discharge following TAVR/EVAR/TEVAR
procedure. |