CTRI/2026/04/107710 [Registered on: 07/04/2026] Trial Registered Prospectively
Last Modified On:
24/08/2026
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Medical Device
Study Design
Single Arm Study
Public Title of Study
Post-Marketing Study of the Sironity Drug-Coated Balloon in Patients With Coronary Artery Disease
Scientific Title of Study
A Post-Market Clinical Follow-up Study of the Sironity Sirolimus-Coated Balloon in Patients With In-Stent Restenosis or De Novo Small Vessel Coronary Lesions:Sironity PMCF Study – INDIA
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ashok Seth
Designation
Chairman - Fortis Escorts Heart Institute
Affiliation
Fortis Escorts Heart Institute
Address
Fortis Escorts Heart Institute, Department of Academics & Research, Room No - 23, Second Floor, RC Building,Residential Tower, Okhla road Sukhdev Vihar Metro Station Delhi 110025
New Delhi DELHI 110025 India
Phone
9871447474
Fax
Email
ashok.seth@fortishealthcare.com
Details of Contact Person Scientific Query
Name
Dr Ashok Seth
Designation
Chairman - Fortis Escorts Heart Institute
Affiliation
Fortis Escorts Heart Institute
Address
Fortis Escorts Heart Institute, Department of Academics & Research, Room No - 23, Second Floor, RC Building,Residential Tower, Okhla road Sukhdev Vihar Metro Station Delhi 110025
DELHI 110025 India
Phone
9871447474
Fax
Email
ashok.seth@fortishealthcare.com
Details of Contact Person Public Query
Name
Dr Ashok Seth
Designation
Chairman - Fortis Escorts Heart Institute
Affiliation
Fortis Escorts Heart Institute
Address
Fortis Escorts Heart Institute, Department of Academics & Research, Room No - 23, Second Floor, RC Building,Residential Tower, Okhla road Sukhdev Vihar Metro Station Delhi 110025
DELHI 110025 India
Phone
9871447474
Fax
Email
ashok.seth@fortishealthcare.com
Source of Monetary or Material Support
Sahajanand Medical Technologies Limited
Primary Sponsor
Name
Sahajanand Medical Technologies Limited
Address
Sahajanand Estate, Wakhariawadi, Near Dabholi Char Rasta, Ved Road, Surat-395004, India
Department of Cardiology, 4th floor, room no.: 4214, Mata Amritanandamayi Marg, Sec 88, Faridabad, Haryana, 121002
Faridabad HARYANA
9871062464
md@fbd.amrita.edu
Dr Sudheer Koganti
Apollo Hospitals
Department of Cardiology, OPD 4th floor, room number 3, Financial District, Nanakramguda Serilingampally, Hyderabad, Telangana 500032, India. Hyderabad TELANGANA
Department of Cardiology, Level 4, Room No. 403, 730, Anandapur, EM Bypass Road, Kolkata- 700107 Kolkata WEST BENGAL
9830024266
shuvananray@gmail.com
Dr Abhishek Vikram Singh
Infinity Care Hospital
Department of Cardiology, 92, 93, Tagore Town, Panchkoshi, Road Orderly
Bazaar, Varanasi, Uttar Pradesh-221002
Varanasi UTTAR PRADESH
9335198465
rajpootvikram@gmail.com
Dr Polavarapu Veera Raghava Sarma
Lalitha PVS Institute of Medical Sciences
Department of Cardiology, Ground Floor, Lalitha PVS Institute of Medical Sciences
NH16, Beside Takkellapadu Flyover, Lalitha Nagar, Guntur – 522001, Andhra Pradesh, India Guntur ANDHRA PRADESH
9440808620
drpvr.lssh@gmail.com
Dr Milan Chag
Marengo CIMS Hospital
Plot 67/1, Opp. Panchmrut Bunglows, Near Shukan Mall, Off Science City Road, Sola, Ahmedabad, Gujarat, 380060 Ahmadabad GUJARAT
9824022107
milan.chag@cims.me
Dr Abhijit Palshikar
Sahyadri Super Speciality Hospital
Department of Cardiology, Floor No. 2, Cathlab Room, Deccan Gymkhana, Plot No. 30C,
Erandawande, Karve Road, Pune 411004, Maharashtra, India Pune MAHARASHTRA
9890336897
dr_abhijeet@yahoo.co
Dr Nimit Shah
Saifee Hospital
Department of Cardiology, OPD, Floor No. 1, Post Box No. 3771, 15/17 Maharshi Karve Marg, Mumbai - 400 004 Mumbai MAHARASHTRA
9833951705
drnimitcshah@yahoo.co.uk
Dr Atul D Abhyankar
Shree B D Mehta Mahavir Heart Instutute,
Cardiac Sciences, Shree Mahavir Health Campus, Athwagate, Ring Road, Surat, Gujarat - 395001. Surat GUJARAT
9825145738
atulda@hotmail.com
Dr Ajit Mullasari S
The Madras Medical Mission
Institute of cardiovascular disease, Department of Cardiology, Room No.: L01, No. 4-A, Dr. J. J. Nagar, Mogappair, Chennai -600037 Chennai TAMIL NADU
0914426565961
icvddoctors@mmm.org.in
Dr Milind Kharche
United CIIGMA Institute of Medical Sciences Pvt. Ltd
Department of clinical research alliance apartment block B first floor G1 , Yashoda hospital Behind Hari Hara Kala bhavan SP Road- secunderabad -500003 telangana, India Hyderabad TELANGANA
Sironity Sirolimus Drug Coated PTCA Balloon Catheter
The Sironity DCB is a rapid-exchange angioplasty balloon catheter with a non-compliant balloon coated with Sirolimus.
Duration - One time during the procedure.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Patient must meet all the following criteria to be eligible for treatment in the study:
1. Adults (more than or equal to 18 years old) with either ISR or de novo lesions in small coronary vessels (reference vessel diameter less than equal to 2.75 mm).
2. Target lesions are considered to require intervention and are suitable for treatment with balloon-based therapy using the Sironity DCB.
3. Multiple target lesions may be treated provided that each lesion is either located in a different target vessel or, if within the same target vessel, is clearly separated by an adequate segment of normal vessel and treated with a separate Sironity DCB. The use of any drug-eluting stent or any drug-coated balloon other than the Sironity DCB in the same target vessel is not permitted.
4. Patients with documented angina and/or positive functional ischemia testing,or presenting with unstable angina, or stabilized non–ST-elevation myocardial
infarction (NSTEMI).
5. Patients with prior ST-elevation myocardial infarction (STEMI) are eligible if the index procedure is performed more than or equal to 14 days post-STEMI and the patient is clinically stable.
6. Lesion length less than or equal to 36 mm.
7. Target vessel diameter within the range specified in the Sironity DCB Instructions for Use (IFU).
8. Able to provide informed consent and comply with the follow-up schedule.
ExclusionCriteria
Details
Patients will be excluded from the study if any of the following criteria are met:
1. Severely calcified lesions or lesions that are heavily thrombotic and not amenable to balloon-based therapy.
3. Known hypersensitivity to sirolimus or any of the components of the Sironity DCB.
4. Patients presenting with ST-elevation myocardial infarction (STEMI).
5. Patients presenting with non–ST-elevation myocardial infarction (NSTEMI) with ongoing chest pain or hemodynamic instability.
6. Patients presenting with Killip class III (pulmonary edema) or class IV (cardiogenic shock).
7. Patients with chronic heart failure classified as NYHA class III or IV prior to the index PCI.
8. Severe left ventricular dysfunction (ejection fraction [EF] less than 30%).
9. Severe renal dysfunction (estimated glomerular filtration rate [eGFR] less than 30mL/min/1.73m²) .
10.Life expectancy less than 1 year due to comorbid conditions unrelated to coronary artery disease.
11.Lesions located in vein grafts, coronary artery bypass grafts, or the left main coronary artery.
12.Target lesion represents a chronic total occlusion (CTO).
13.Active bleeding disorders or patients with uncontrolled anticoagulation.
14.Pregnancy or breastfeeding (due to the potential risks associated with sirolimus).
15.Severe systemic illness or other conditions that, in the opinion of the investigator, would interfere with the patients ability to complete the study follow-up.
16. Patients currently enrolled in another investigational drug or device study that has not yet completed primary endpoint follow-up
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Target lesion failure (TLF), which is defined as a composite of cardiac death (CD), target-vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR)
12 months
Secondary Outcome
Outcome
TimePoints
Acute success (device, and procedure)
Through hospital discharge only
All deaths
Hospital discharge, 30 days, 6 and 12 months
Cardiac death
Hospital discharge, 30 days, 6 and 12 months
All myocardial infarction (MI), including TV-MI
Hospital discharge, 30 days, 6 and 12 months
CD-TLR defined as repeat PCI or CABG to the target lesion
Hospital discharge, 30 days, 6 and 12 months
Clinically-driven target vessel revascularization (CD-TVR) defined as repeat PCI or CABG to the target vessel
Hospital discharge, 30 days, 6 and 12 months
Major adverse cardiac event (MACE) defined as composite of all-cause mortality,any MI, any stroke, hospitalization for heart failure, or any revascularization
Hospital discharge, 30 days, 6 and 12 months
TLF defined as composite of cardiac death, TV-MI, or CD-TLR
Hospital discharge, 30 days, and 6 months
Target vessel failure (TVF) defined as composite of cardiac death, TV-MI, or CDTVR
Hospital discharge, 30 days, 6 and 12 months
Target lesion thrombosis (TLT) (definite or probable)
Hospital discharge, 30 days, 6 and 12 months
BARC 3–5
Hospital discharge, 30 days, 6 and 12 months
Any stroke
Hospital discharge, 30 days, 6 and 12 months
Target Sample Size
Total Sample Size="164" Sample Size from India="164" 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
Post Marketing Surveillance
Date of First Enrollment (India)
15/04/2026
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)
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
This is a prospective, multicenter, observational PMCF study aims to evaluate the clinical safety and performance of the Sironity Sirolimus Coated PTCA Balloon Catheter in real world Indian patients undergoing PCI for either in stent restenosis (ISR) or de novo small vessel coronary lesions (reference vessel diameter less than or equal to 2.75 mm). A total of 164 patients (60 ISR and 104 de novo small vessel disease) will be enrolled, with standard of care treatment and follow up at 30 days, 6 months, and 12 months. Additionally, first 30 consecutive eligible patients (15 with in-stent restenosis [ISR] and 15 with de novo small-vessel disease [DNSV]) will undergo detailed quantitative coronary angiography (QCA) at baseline and 6 months. The primary endpoint is 12 month target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization.