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Safety and Effectiveness of the AGENT Drug-Coated Balloon in Adults with Coronary Artery Disease Undergoing Coronary Angioplasty

Prospective, Open-Label, Real-World Registry Evaluating Safety and Performance of AGENT Drug-Coated Balloon in Coronary Artery Disease: Insights into Lesion Preparation Strategies - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/112954
Enrollment
1000
Registered
2026-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I21A- Other type of myocardial infarction

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

THE Madras Medical Mission
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years CAD requiring PCI with DCB strategy for de novo lesions only Lesion suitable for balloon-based therapy Informed consent provided

Exclusion criteria

Exclusion criteria: ST-elevation MI within 48 hours In-stent restenosis Left main disease Thrombus-containing lesions. Severe calcification viz., Calcium arc more than 180 , length more than 5 mm, and thickness more than 0.5 mm on intravascular imaging or calcium on both sides of the arterial wall seen on fluoroscopy Pregnancy Contraindication to antiplatelet therapy. Life expectancy less than 1 year

Design outcomes

Primary

MeasureTime frame
Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) within 12 months post-procedure. Analysis: TLF will be evaluated using time-to-event methods, including Kaplan Meier survival curves for event-free survival and Cox proportional hazards models to identify predictors of TLF. Timepoint: 12 MONTHS—

Secondary

MeasureTime frame
Procedural Success: Procedural success, defined as successful delivery and inflation of the AGENT DCB at the target lesion, absence of flow-limiting dissection, and no in-hospital MACE. Target lesion Failure (TLF): Individual components of TLF viz., all-cause death, target vessel myocardial infarction (TVMI), stroke, and clinically driven target lesion revascularization (TLR) during the entire follow-up period. Bailout Stenting: Incidence of bailout stent implantation, with systematic documentation of underlying reasons (e.g., flow-limiting dissection, recoil, or inadequate lesion preparation). Economic Evaluation: Cost-analysis metrics including procedural resource utilization and follow-up healthcare costs. Timepoint: 12 MONTHS—

Countries

India

Contacts

Public ContactDR AJIT MULLASARI S

THE MADRAS MEDICAL MISSION

clireco@mmm.org.in04426568399

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026