Translumina Therapeutics Private Limited,
Located at Ground Floor, Metro Tower,
Local Shopping Complex, MOR Land,
New Rajinder Nagar, New Delhi -110060 India
Institutional Ethics Committee Asian Institute of Gastroenterology (IEC-AIG)
Approved
Institutional Ethics Committee Care Hospital
Approved
Institutional Ethics Committee- Clinical Trials
Approved
Institutional Human Ethical Committee
Approved
Jay Prabha Medanta Super Speciality Hospital Institutional Ethics Committee
Approved
KD Hospital Institutional Ethics Committee
Approved
KIMS Ethics Committee
Approved
Medanta Institutional Ethics Committee
Approved
Redkar Hospital and Research Center Institutional Ethics Committee
Approved
Rhythm Heart Institute Ethics Committee
Approved
Rukmani Birla Hospital, Jaipur – A unit of Calcutta Medical Research Institute
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
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
Nil
Nil
Comparator Agent
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Age above 18 years
2. Patients with symptomatic coronary artery disease (including those with acute coronary syndromes (except Acute STEMI) or Chronic Coronary Syndromes) with either symptoms and/or ischemia.
3. The patient must be able to understand and provide informed consent and comply with all study procedures.
Angiographic inclusion criteria
1. Greater than or equal to 70% target lesion stenosis in LAD, LCX, or RCA (or branches) which after successful pre-dilatation has a residual stenosis, less than or equal to 30% and no dissection greater than Type C (NHLBI guidelines)
(pre-dilatation permitted with SC or NC balloon catheter, cutting/scoring balloon, rotational/orbital atherectomy, IVL or laser)
2. The target vessel reference diameter must be between 2.0 and 4.5 mm.
ExclusionCriteria
Details
1. LVEF less than or equal to 30%
2. Known contraindication or hypersensitivity to paclitaxel, and/or to any anti-thrombotic and anti-platelet class of drugs.
3. Allergy to imaging contrast media which cannot be adequately pre-medicated.
4. Patient undergoing planned surgery within 3 months with the necessity to stop DAPT.
5. Patient is pregnant or nursing lactating women.
6. Patient is recipients of a heart transplant.
7. Patient is unwilling or unable to give follow-up till study completion.
8. Currently participating in another trial.
9. Life Expectancy less than 1 year.
Angiographic exclusion criteria:
1. Target lesion is in the left main coronary artery.
2. Flow limiting target vessel thrombus.
3. Vessel dissection requiring bailout stenting
(in the case of bailout stenting only follow-up will be excluded. We won’t follow up the patient with bailout stenting, but the baseline and procedural data will be collected for the patient as that will provide us the frequency of vessel injury during the DCB/DEB angioplasty procedure).
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
The primary endpoint of the study is TLF rate through 12 months.
(The primary endpoint of the study is a composite endpoint. Cumulative TLF is defined as events of Cardiac Deaths, Target vessel-related Myocardial Infarction, and clinically driven Target Lesion Revascularization at 12 months after the index procedure.)
12 Month
Secondary Outcome
Outcome
TimePoints
1. Device success - Defined as the ability of the study device to be delivered, dilated and retrieved from the target lesion.
2. Procedural success Defined as technical and angiographic success in the absence of major adverse events during hospitalization.
3. Patient Oriented Composite Endpoints (PoCE)- Composite of all cause death, any MI, or any revascularization.
6 month and 12 month
Target Sample Size
Total Sample Size="1000" Sample Size from India="1000" 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)
14/04/2025
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
Prospective, Single-arm, Multi-center, Post-marketing,
Observational, Open label Registry tocollectdataonsafetyandefficacyof (Paclitaxel Coated Coronary Balloon Dilatation Catheter) used during
routine clinical practice in all comers’ CAD population (including Subjects
with stable angina, unstable angina or silent ischemia and acute coronary
syndromes) undergoing Percutaneous treatment with Drug Eluting/Coating Balloon.
All the data of the Subjects’ demographic characteristics, co-morbidities and
laboratory parameters details will be collected from medical records during
patient procedure visit and follow-up visit, and all clinical characteristics
will be recorded in the case record form (CRF) or e-CRF