| CTRI Number |
CTRI/2024/09/073616 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prospective] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study whether side branch strut opening using kissing balloon inflation after provisional left main stenting will improve the side branch outcome. |
|
Scientific Title of Study
|
Impact of Kissing balloon inflation on provisional Left Main Percutaneous Coronary Intervention: A Prospective Multicenter Randomized Trial(IKISS-LM Trial) |
| Trial Acronym |
IKISS-LM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankush Gupta |
| Designation |
Professor of Medicine Interventional Cardiologist |
| Affiliation |
Army Institute of Cardio Thoracic Sciences |
| Address |
Department of Cardiology, Ground Floor, Room No.5, Golibar Maidan
Pune
MAHARASHTRA
411040
India |
| Phone |
9592903488 |
| Fax |
|
| Email |
drankushgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankush Gupta |
| Designation |
Professor of Medicine Interventional Cardiologist |
| Affiliation |
Army Institute of Cardio Thoracic Sciences |
| Address |
Department of Cardiology, Ground Floor, Room No.5, Golibar Maidan
Pune
MAHARASHTRA
411040
India |
| Phone |
9592903488 |
| Fax |
|
| Email |
drankushgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankush Gupta |
| Designation |
Professor of Medicine Interventional Cardiologist |
| Affiliation |
Army Institute of Cardio Thoracic Sciences |
| Address |
Department of Cardiology, Ground Floor, Room No.5, Golibar Maidan
Pune
MAHARASHTRA
411040
India |
| Phone |
9592903488 |
| Fax |
|
| Email |
drankushgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army Institute of Thoracic Sciences (AICTS) Department of Cardiology Golibar Maidan Pune 411040 |
|
|
Primary Sponsor
|
| Name |
Principal Investigator |
| Address |
Army Institute of Thoracic Sciences (AICTS) Department of Cardiology Golibar Maidan Pune 411040 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankush Gupta |
Army Institute of Cardio Thoracic Sciences |
Department of Cardiology, Ground Floor, Room No.5, Golibar Maidan
Pune
MAHARASHTRA |
9592903488
drankushgupta@gmail.com |
| Dr Sujatha Vipperla |
INDUS Hospitals |
Department of Cardiology, Visakhapatnam, Andhra Pradesh,530002
Visakhapatnam
ANDHRA PRADESH |
9912222431
vipperlasujatha@gmail.com |
| Dr Sajan Narayanan |
Little Flower Hospital & Research Centre |
Department of Cardiology, P.B. No. 23, Angamaly, Kerala
Ernakulam
KERALA |
8086842627
sajannarayanan@gmail.com |
| Dr S Selvamani |
Meenakshi Mission Hospital and Research Centre |
Department of Cardiology, Lake area, Melur Road, Madurai, 625107
Madurai
TAMIL NADU |
9842158868
maniselvacardio@gmail.com |
| Dr Arun Gopi |
Metromed International Cardiac Centre Pvt. Ltd. |
Department of Cardiology, Thondayad Bypass road, Kozhikode, Kerala
Kozhikode
KERALA |
8157047371
arungopi@gmail.com |
| Dr Rajesh Vijayvergiya |
Post Graduate Institute of Medical Education and Research |
Department of Cardiology, Advanced Cardiac Centre, PGIMER, 3rd Floor, C Block, Room No. 3002
Chandigarh
CHANDIGARH |
9815221856
rajeshvijay999@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Army Hospita; (R&R) Delhi |
Approved |
| Arneja Heart & Multispeciality Hospital |
Approved |
| Indus Hospitals |
Approved |
| Institutional Ethics Committee Armed Forces Medical College |
Approved |
| Little Flower Hospital &Rsearch Centre |
Approved |
| Meenakshi Mission Hospital & Research Centre |
Approved |
| Metromed International Cardiac Centre Pvt. Ltd. |
Approved |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee |
Approved |
| ST. GREGORIOS MEDICAL MISSION HOSPITAL |
Approved |
| The Madras medical Mission |
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 |
Kissing Balloon Inflation (KBI) |
In KBI group SB is rewired through the distal stent struts, which can be confirmed by imaging (in L mode for IVUS and 3D reconstruction of SBO for OCT) and/or stent boost guidance and a final kissing balloon inflation will be done. For KBI, MB balloon is sized as per its DRD and SB balloon is sized 0.5mm less than SB DRD (10 mm from the ostium). Operators are encouraged to use NC balloon for the KBI and to perform Re-POT after KBI. After KBI both MB and SB is imaged and beside stent expansion, apposition, edge dissection, plaque prolapse and geographical miss, number of stent struts across SBO and MB stent deformation is noted. SB imaging is studied for any significant dissection caused due to KBI. |
| Comparator Agent |
Non-Kissing Inflation Balloon (Non-KBI) |
After placement of stent from LM to main branch and POT of LM, side branch is not rewired and imaging will be done in main branch only. Imaging run will be assessed for expansion, apposition, edge dissection, plaque prolapse and geographical miss. Stent is optimized to get expansion of more than 85% in both LM and LAD separately. In case of OCT, 3D reconstruction of SBO will be done and assessed for number of stent struts across SBO, link free or link connecting type carina. If IVUS is used as the imaging modality, L mode is analyzed for counting the number of stent struts across SBO. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Non-complex distal LM bifurcation disease requiring percutaneous coronary intervention.
2. Unprotected left main
3. Patient ≥18 years old and willing to participate in the trial
|
|
| ExclusionCriteria |
| Details |
1. Complex LM bifurcation disease requiring upfront two-stent strategy.
2. Patients previously underwent CABG
3. Patients who underwent previously stenting to LM to LAD or LCX
4. Allergic to antiplatelets (Aspirin, Clopidogrel, Ticagrelor, Prasugrel) or unable to use dual antiplatelet therapy (DAPT)
5. Life expectancy less than 1 year
6. Patient unable to give informed consent
7. Women of child-bearing potential or lactating
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary endpoint of the study will be angiographically significant stenosis (greater than 50 percent stenosis by visual estimation) at the end of one year. |
At the end of one year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A composite of cardiac death, non-fatal myocardial infarction or target vessel failure at the end of 1 year. Other secondary end points include target vessel failure, stent thrombosis. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="630"
Sample Size from India="630"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
With the advent of newer generation drug eluting stents (DES) and the subsequent reduction in restenosis rates, stenting of left main (LM) for distal bifurcation lesions has become a potential alternative to coronary artery bypass graft surgery (CABG). |