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Study on a Sirolimus Balloon for Treating Narrowed Heart Arteries

A Real-World, Single-Center, Ambispective Observational Study on Sirolimus Drug-Eluting Balloons: Evaluating Safety, Performance, and Clinical Outcomes in the Treatment of Stenotic Coronary Artery Lesions - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096560
Enrollment
70
Registered
2025-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: I259- Chronic ischemic heart disease, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Meenakshi Super Specialty Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the Patients who have been treated with Sirolimus Eluting Coronary Balloon had completed minimum 6-month follow-up. Participant is willing to undergo all study-related follow-up requirements.

Exclusion criteria

Exclusion criteria: All the Patients who have not been treated with Sirolimus Eluting Coronary Balloon System had not completed minimum 6-month follow-up. Participant is not willing to undergo all study-related follow-up requirements

Design outcomes

Primary

MeasureTime frame
1. Major Adverse Cardiac Events 2. Quality of Life questionnaire 3. Adverse Events or Serious adverse eventsTimepoint: 1. Time Frame: Baseline, post-procedure, Through 6 months, 12 months ± 15 days 2.Time Frame: Through 6 months, 12 months ± 15 days 3. Time Frame: Baseline, post-procedure, Through 6 months, 12 months ± 15 days

Secondary

MeasureTime frame
1. All Mortality rate 2. Procedural Success and Device SuccessTimepoint: 1. Time Frame: Baseline, post-procedure, Through 6 months, 12 months ± 15 days 2. Time frame: Post-procedure and Intra-operative

Countries

India

Contacts

Public ContactDr Sivakumar Rathnavel

Meenakshi Super Specialty Hospital

drsivakumar2004@gmail.com9842158870

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026