| CTRI Number |
CTRI/2024/07/069759 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of drug coated balloons for ostial coronary lesions |
|
Scientific Title of Study
|
Comparison of outcomes of drug coated balloon angioplasty and plain old balloon angioplasty of ostial coronary lesions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asmita Gupta |
| Designation |
DM Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Cardiology, SSB building, Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
7042221034 |
| Fax |
|
| Email |
asmitagupta066@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H S Isser |
| Designation |
Professor and HOD |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Cardiology, SSB building, Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9899128399 |
| Fax |
|
| Email |
drhsisser@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Gupta |
| Designation |
DM Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Cardiology, SSB building, Safdarjung Hospital, New Delhi
DELHI
110029
India |
| Phone |
7042221034 |
| Fax |
|
| Email |
asmitagupta066@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, New Delhi, India. PIN 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung hospital |
| Address |
VMMC and Safdarjung hospital, Mahatma Gandhi Marg, Ansari Nagar West, New Delhi, 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Asmita Gupta |
VMMC and Safdarjung Hospital |
Department of Cardiology, VMMC and Safdarjung Hospital, Mahatma Gandhi Marg, Ansari Nagar West, New Delhi- 110029
South
DELHI |
7042221034
asmitagupta066@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee, VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug coated balloon angioplasty |
Angioplasty of specified ostial coronary lesions using drug coated balloon (one time intervention followed by 6 month follow up) |
| Comparator Agent |
Plain Old Balloon Angioplasty |
Plain old balloon angioplasty (POBA) of specified ostial coronary lesions (one time intervention followed by 6 month follow up) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Stable angina with documented ischemia or typical symptoms with ECG changes or Unstable angina
2. Eligible for PCI with the intention to use balloon only strategy for de novo side branch ostial lesion (Medina classification 0,0,1)
3. Side branch with diameter greater than 2.0mm |
|
| ExclusionCriteria |
| Details |
1. Left main bifurcation except isolated ostial LCX lesion.
2. If angioplasty of any other lesion is required/ performed with study procedure.
3. Severely calcified lesions
4. Contraindications to DAPT
5. History of hypersensitivity to contrast
6. Prior stenting in target vessel |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Angiographic outcomes:
1. Minimum lumen diameter (MLD)
2. Percentage of diameter stenosis
3. Percentage of area stenosis
4. Acute luminal gain
5. Late lumen loss
6. Loss index |
Procedural and 6 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. In hospital and short term composite MACE
2. Death
3. MI: STEMI or NSTEMI
4. Revascularisation: Target lesion revascularisation, or stenting in new lesion, or coronary bypass surgery
5. Cerebrovascular accident |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/07/2024 |
| 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="1"
Months="6"
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
|
Thus study is a randomized parallel group trial comparing Drug coated balloon (DCB) angioplasty and Plain Old Balloon Angioplasty (POBA) for ostial coronary lesions. This study will be conducted in Department of Cardiology, VMMC and Safdarjung Hospital, New Delhi. 60 patients undergoing PCI with intention to use balloon only strategy for de novo side branch ostial lesion (Medina 0,0,1) meeting inclusion criteria will be included. The patients will be followed up after a period of 6 months. Primary (angiographic) and secondary (clinical) outcomes will be assessed at follow-up. |