| CTRI Number |
CTRI/2024/02/062920 [Registered on: 20/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the safety and performance of the Relisys Post-dilatation catheters in PTCA. |
|
Scientific Title of Study
|
A Retrospective, Open-label, Non-randomized Post-Market Clinical Follow up study to assess the safety and performance of the Relisys Post-dilatation catheters in human subjects who underwent coronary angioplasty. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| QUIN-NC V1.1 dated 08 Sep 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay R Tarlekar |
| Designation |
Principal Investigator |
| Affiliation |
Sushrusha Heart Care Center & Multi Speciality Hospital |
| Address |
Sushrusha Heart Care Center & Multi Speciality Hospital, Cardiology department, 1st floor, Plot No. 22/A, Phase III, Palm Beach Road, sector 6 Nerul West
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9322297664 |
| Fax |
|
| Email |
srtarlekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Voruchu |
| Designation |
Clinical Research Associate |
| Affiliation |
Relisys Medical Devices Limited |
| Address |
Survey No. 312, Ibrahimpatnam Mandal, Mangalpally,
Hyderabad
TELANGANA
501510
India |
| Phone |
9618080999 |
| Fax |
|
| Email |
Snehav@relisys.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Voruchu |
| Designation |
Clinical Research Associate |
| Affiliation |
Relisys Medical Devices Limited |
| Address |
Survey No. 312, Ibrahimpatnam Mandal, Mangalpally,
TELANGANA
501510
India |
| Phone |
9618080999 |
| Fax |
|
| Email |
Snehav@relisys.in |
|
|
Source of Monetary or Material Support
|
| Relisys Medical Devices Limited
Survey No.312, Pocharam Road, Mangalpally Village,
Ibrahimpatnam Mandal, Ranga Reddy District, Telangana– 501510, India. |
|
|
Primary Sponsor
|
| Name |
Relisys Medical Devices Limited |
| Address |
Survey No.312, Pocharam Road, Mangalpally Village,
Ibrahimpatnam Mandal, Ranga Reddy District, Telangana– 501510, India. |
| Type of Sponsor |
Other [Medical Device company] |
|
|
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 Sanjay R Tarlekar |
Shushrusha Heart Care Centre and Multispeciality Hospital |
Cardiology department, 1st floor, Plot No. 22/A, Phase III, Palm Beach Road, sector 6 Nerul West,
Mumbai
MAHARASHTRA |
9102227700273
srtarlekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksha Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I708||Atherosclerosis of other arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Post-dilatation catheter |
The Post-dilatation balloon
catheter is proposed to achieve better uniform stent expansion after the stent deployment. Post Dilatation Balloon catheter is used to dilatation of a stent after implantation. This catheter is not containing any drug, hence the dose is not applicable. This device is intended for one time use only. The route of approach is radial or femoral. The duration of balloon dilatation is less than 60sec. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.The patient must be 18 years of age or older, irrespective of gender.
2.Subjects who underwent treatment with stenotic lesions in coronary arteries or bypass graft stenosis for percutaneous coronary intervention (PCI).
3.The patient had single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and, or a positive functional study.
4.Underwent treatment with Relisys post-dilatation catheters during the period Jan2019–Dec 2023.
5.The subject must have denovo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
6.A maximum of three lesions, including at least one target lesion, in up to two coronary arteries.
7.Target and non-target lesions must be in different coronary arteries or bypass grafts.
8.The target lesion(s) must have a diameter stenosis of greater than 70percentage by visual estimation and be amenable to percutaneous intervention. |
|
| ExclusionCriteria |
| Details |
1.Pregnant Female.
2.Presence of any known life-threatening non-cardiac (major or progressive) disease that will limit the patients life expectancy.
3.Documented evidence of significant renal dysfunction dysfunction(serum
creatinine less than 3.0mg per dl) or on any form of dialysis.
4.Psychiatric or behavioral disease, including known alcohol or drug abuse (continued use of alcohol, illegal drugs, or the misuse of prescription or over-the-counter drugs with negative physical or psychological consequences).
5.Subjects who have known hypersensitivity to device materials.
6.The patient has any other concurrent conditions that, in the opinion of the investigator, may compromise patient safety, privacy, and study objectives. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the safety of Relisys Post-dilatation
catheter in patients. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the performance of Relisys Post-dilatation
catheter in patients. |
Baseline. |
|
|
Target Sample Size
|
Total Sample Size="254"
Sample Size from India="254"
Final Enrollment numbers achieved (Total)= "254"
Final Enrollment numbers achieved (India)="254" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/02/2024 |
| Date of Study Completion (India) |
11/07/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a retrospective, non-randomized, open-label, single-arm post-marketing clinical follow-up study. The evaluation exhibits the safety and performance of the Relisys post-dilatation catheters in human subjects who underwent coronary angioplasty. The study is designed to collect 5-year clinical data from patients from a single center where the device was consistently placed. The data from January 2019 to December 2023 on patients who underwent coronary angioplasty in the selected center and, during the procedure, Relisys post-dilatation catheters of different brands like VEDA+R NC, JADE-NC, PEARL-NC, etc. that were used in patients will be collected. This retrospective data will be analyzed to assess the safety and performance of the device. |