| CTRI Number |
CTRI/2024/02/062723 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate the safety and performance of dedicated bifurcation stent in patients with de novo coronary bifurcation lesions. |
|
Scientific Title of Study
|
Dedicated Branch Stent vs Conventional Stent in Bifurcation Coronary stenosis -A medium term followup |
| 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, Sanathnagar, 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 |
ESIC Super Speciality Hospital |
| Address |
Esic Super Speciality Hospital ,Sanath Nagar ,Hyderabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 the device on procedure day and will be followup done by 30days ,six Months ,One year ,Two Years |
| Comparator Agent |
Medical Device |
Participants will be randomized for the device on procedure day and will be followup done by 30 days ,six Months ,One year ,Two Years
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.The patientmustbegreaterthan euqal 18 years of age.2.True coronary bifurcation greaterthan equal to 50 percentage diameter stenosis in both the main and side branches, belonging to the Medina classes 1,1,1 or 1,0,1 or 0,1,1.3.Patients with de novo bifurcation lesions in native coronary arteries with reference diameter ranging from 2.5 mm to 3.5 mm in the side branch and 2.5 mm to 4.0 mm in main branch4.Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure.
5.The patient is willing to comply with protocol specified follow-up evaluations.6.Patient or his or her legally authorized representative if applicable agrees to provide written informed consent as approved by respective Ethics Committee and applicable regulatory authorities. |
|
| ExclusionCriteria |
| Details |
1.Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drug such as Sirolimus Rapamycin or similar drugs or any analogue or derivative, cobalt, chromium, nickel, molybdenum, tungsten or any contrast media.2.Patients in whom anti-platelet and or anticoagulant therapy are contraindicated. 3.Angiographic evidence of thrombus.4.Direct stenting of the left main bifurcation 5.Impaired runoff in the treatment vessel with diffuse distal disease.6.A significant greaterthan 50 percentage stenosis proximal to distal to the target lesion.
7.Ejection fraction lessthan 30 percentage 8.Patient requiring anticipated rotational atherectomy as per the Investigators judgement.
9.Highly calcified lesions in which full stent dilatation may not be possible.10.Patients with totally occluded vessel.11.Target lesion has excessive tortuosity unsuitable for stent delivery and deployment. 12.Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon. 13.Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant. 14.Pregnant or nursing patients or those who plan pregnancy during study period 15.Any condition, which in the Investigators opinion would preclude safe participation of patient in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
ï‚·Major Adverse Cardiac Events (MACE) [Time Frame: 1 Year]
Major adverse cardiac events are the composite of cardiac death, Target vessel myocardial infarction (TV-MI) and clinically driven target lesion revascularization (CD-TLR) [1] |
ONE YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiac Death: |
30 days , six months , one year ,Two years |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 Yet Recruiting |
| 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
|
Bifurcation lesions are common and associated with higher risks of major cardiac events and restenosis after percutaneous coronary intervention (PCI). Treatment requires understanding of lesion characteristics, stent design and therapeutic options. We review the evidence for provisional vs 2-stent techniques. We conclude that provisional stenting is suitable for most bifurcation lesions. We detail situations where a 2-stent technique should be considered and the steps for performing each of the 2-step techniques. We review the importance of lesion preparation, intracoronary imaging, proximal optimization (POT) and kissing balloon inflation |