| CTRI Number |
CTRI/2023/08/056616 [Registered on: 17/08/2023] Trial Registered Prospectively |
| Last Modified On: |
14/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Post-market study of Pipit-NC Balloon Dilatation Catheter |
|
Scientific Title of Study
|
Post-market evaluation of safety & performance of Pipit-NC PTCA Balloon Dilatation Catheter in patients with stenotic coronary arteries during percutaneous coronary intervention |
| Trial Acronym |
Pipit-NC PMCF Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PIPIT-NC/PTCA/001, Version 1.0, 1 June 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul D Abhyankar |
| Designation |
Clinical Director – Interventional Cardiology |
| Affiliation |
Shree B. D. Mehta Mahavir Heart Institute |
| Address |
Department of Interventional Cardiology, Athwagate, Ring Road,
Surat
GUJARAT
395001
India |
| Phone |
9824145738 |
| Fax |
|
| Email |
atulda.abhyankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul D Abhyankar |
| Designation |
Clinical Director – Interventional Cardiology |
| Affiliation |
Shree B. D. Mehta Mahavir Heart Institute |
| Address |
Department of Interventional Cardiology, Athwagate, Ring Road,
Surat
GUJARAT
395001
India |
| Phone |
9824145738 |
| Fax |
|
| Email |
atulda.abhyankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul D Abhyankar |
| Designation |
Clinical Director – Interventional Cardiology |
| Affiliation |
Shree B. D. Mehta Mahavir Heart Institute |
| Address |
Department of Interventional Cardiology, Athwagate, Ring Road,
Surat
GUJARAT
395001
India |
| Phone |
9824145738 |
| Fax |
|
| Email |
atulda.abhyankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sahajanand Medical Technologies Ltd. (SMT), Sahajanand Estate, Wakhariawadi, Near Dabholi, Ved Road, Surat – 395004, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Sahajanand Medical Technologies Ltd. (SMT) |
| Address |
Sahajanand Estate, Wakhariawadi, Near Dabholi, Ved Road, Surat – 395004, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
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 Atul Abhyankar |
Shree B. D. Mehta Mahavir Heart Institute |
Department of Interventional Cardiology, Athwagate, Ring Road, Surat-395001, India
Surat
GUJARAT |
9824145738
atulda.abhyankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree B.D. Mehta Mahavir Heart Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I209||Angina pectoris, unspecified, |
|
|
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 |
1. Patient must be at least 18 years of age
2. Patient or a legally authorized representative must provide written informed consent prior to any study related procedure
3. Patient must agree not to participate in any other clinical study during hospitalisation for the index procedure
4. Target lesion(s) can be treated with Pipit-NC PTCA Balloon Dilatation Catheter as per the current IFU. |
|
| ExclusionCriteria |
| Details |
Patient not meeting any of the above inclusion criteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Device Success
2. Procedural success |
Baseline
(From the start to end of the interventional procedure) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Individual procedural parameters
- Coronary perforation
- Coronary dissection
- Coronary thrombosis
- Clinically significant arrhythmias (requiring intervention) |
Up to end of PTCA procedure |
Safety endpoints
- All-cause mortality
- Any MI
- Any revascularization |
Up to hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
Final Enrollment numbers achieved (Total)= "87"
Final Enrollment numbers achieved (India)="87" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2023 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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, observational, multi-center, single-arm, investigator-initiated study. A total of 87 consecutive patients who will be treated with at least one Pipit-NC PTCA balloon dilatation catheter during their index procedure (pre-dilation and/or post-dilation after stent deployment) will be enrolled according to routine clinical practice. A separate Pipit-NC PTCA balloon dilatation catheter will be used for pre-dilation, and post-dilation after stent deployment. The Pipit-NC PTCA balloon dilatation catheter will be used in multiple lesions, but data from the first treated lesion will be used for the analysis of primary and secondary outcomes. |