| CTRI Number |
CTRI/2024/02/062701 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A prospective study to evaluate safety and performance of Bioresorbable Vascular Scaffold along with Drug eluting balloon in patients with long diffused de-novo coronary lesions. |
|
Scientific Title of Study
|
Metalless PCI Registry -
A prospective, single-arm, single-centre registry to evaluate safety and performance of Bioresorbable Vascular Scaffold along with drug-eluting balloon in patients with long diffused de-novo coronary lesions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sadanand Reddy |
| Designation |
Interventional Cardiologist |
| Affiliation |
ESIC Hospital ,sanath Nagar, Hyderabad |
| Address |
Head of the Department ,Department of Cardiology ,first Floor,Room no-2
ESIC super speciality Hospital,Hyderabad
ESIC super speciality Hospital,Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
8142345693 |
| Fax |
|
| Email |
tummalasreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yathish kumar |
| Designation |
Clinical Assistant |
| Affiliation |
Meril Life Sciences Pvt Ltd |
| Address |
New No.45/23, Ist Floor, First Main Road, Shenoy Nagar West, Chennai, Tamil Nadu
TAMIL NADU
600030
India |
| Phone |
8019851312 |
| Fax |
|
| Email |
yathishkumar555@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yathish kumar |
| Designation |
Clinical Assistant |
| Affiliation |
Meril Life Sciences Pvt Ltd |
| Address |
New No.45/23, Ist Floor, First Main Road, Shenoy Nagar West,, Chennai, Tamil Nadu
TAMIL NADU
600030
India |
| Phone |
8019851312 |
| Fax |
|
| Email |
yathishkumar555@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Super speciality Hospital ,Sanath Nagar ,Hyderabad |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
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 Sadanand Reddy |
ESIC Super Speciality Hospital |
Department of cardiology ,First floor , Cathlab Room no-10 ,
Hyderabad
TELANGANA |
8142345693
tummalasreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ESIC Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Coronary artery disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medical Device |
Participants will be randomized for medical device on the day of procedure and followup will be taken for six months ,one year ,Two Years ,Three Years ,Four Years, Five years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged greaterthan equal to 18 years.
2.Patients with long diffused de-novo coronary lesions greaterthan 25 mm suitable for treatment with BRS along with drug eluting balloon.3.Patient has given written informed consent for participation prior to enrolment.4.Patient is willing to undergo all study procedures and follow-up requirements. |
|
| ExclusionCriteria |
| Details |
1.Hypersensitivity or allergy to aspirin, heparin, clopidogrel, bivalirudin, ticlopidine, prasugrel, ticagrelor and drug such as Sirolimus Rapamycin or similar drugs or any analogue or derivative, poly L lactide PLLA, poly DL lactide PDLLA, platinum, or with any contrast media.2.Patient in whom antiplatelet and or anti coagulant therapy are contraindicated.3.Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon.4.Transplant patient. 5.Patients with low ejection fraction Lessthan30percentage
6.Renal insufficiency where creatinine levels are more than 1.3 mg per dl 7.Patients with vascular aneurysms 8.Lesion located in left main coronary artery 9.Aorto ostial location within 3 mm
10.Patients with Chronic Total Occlusions
11.Patients with bifurcation or trifurcation lesion disease or multivessel complex lesions
12.Patients with severely calcified vessels and angulations 13.Subject is high risk of bleeding for any reason.14.Pregnant or lactating female.
15.Any condition, which in the Investigators opinion would preclude safe participation of patient in the study. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Target Lesion Failure (TLF) [Time Frame: 1 year]
Defined as the composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a non-target vessel), or ischemia-driven target lesion revascularization (ID-TLR)[1].
|
one month ,six month , one year, Two Years ,Three Years ,Four Years ,Five Years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.Stroke: [Time Frame: Time Frame: 1 month, 6 months, 1 year, 2years, 3 years, 4 years, 5 years][5]
8.Thrombosis [Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
9,Procedure success [Time Frame: Discharge]
10.Device success: [Time Frame: During procedure]
11.Length of Hospital Stay [Time Frame: at Discharge]
12,Re-hospitalization |
one month ,six month , one year, Two Years ,Three Years ,Four Years ,Five Years
|
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/12/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The currently approved MeRES 100 – is a novel 100micron thick bio-resorbable PLLA scaffold has been tested and found safe and effective among Indian CAD patients. MeRES 100 has been available for human use for PCI since January 2021 and currently its use is restrictive for few types of CAD lesions that are short segment involvement in vessels over diameter 2.75mm or more up to 4.0mm. As CAD affects many young subjects in India, this MeRES Bio-resorbable scaffold offers an effective PCI solution to many with single or multi-vessel CAD involvement and retains the option of further PCI or CABG surgery should the atherosclerosis disease progresses in these patient subjects in future unlike metal jacketed DES in the vessels that precludes graft anastomosis in such vessels implanted with DES |