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Randomised trial comparing two different types of drug eluting stent- without polymer and with biodegradable polymer

Open labeled randomised controlled trial to evaluate the clinical outcome of polymer free sirolimus eluting coronary stent as compared to biodegradable polymer based sirolimus eluting coronary stent

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/03/004512
Enrollment
204
Registered
2014-03-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients with coronary artery disease requiring coronary angioplasty as treatment modality

Interventions

Intervention1: Sirolimus eluting non polymer stent: Drug eluting stent ( sirolimus based polymer free stent) delivered thourgh intra arterial route, stent placed within the vessel at site of stenosis.

Sponsors

Government Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with stable coronary artery disease/ Unstable angina / NSTEMI / or recent myocardial infarction ( more than one week from the day of MI) who are being taken up for elective angioplasty

Exclusion criteria

Exclusion criteria: 1. Patients older than 80 years 2. Patients who are have developed adverse drug reactions or are allergic to aspirin, clopidogrel or statins 3. Patients with chronic renal failure 4. Patients who are likely to discontinue medications or whose compliance is questionable 5. Patients with expected survival of less than one year due to co-morbid conditions 6. Patients with severe peripheral vascular disease 7. Patients who are within one week of a myocardial infarction( STEMI) 8. Patients who refused informed consent 9. Patient who insist on pursuing treatment under alternative systems of Medicine like Ayurveda, Homeopathy, Unani, or Siddha 10. Patients with significant valvular heart disease other than Mitral valve prolapse with mild mitral regurgitation 11. Patients who require anti-coagulation for other reasons like intra -mural thrombus, atrial fibrillation, or valve replacement.

Design outcomes

Primary

MeasureTime frame
Composite of cardiac death, Clinically driven target vessel revascularisation and MI ( both fatal and non fatal)Timepoint: The follow up period is for one year from the last recruitment. All events in this time period will be taken.

Secondary

MeasureTime frame
1) Cardiac death at the end of one year 2) MI ( fatal and non fatal ) at the end of one year 3) Non Fatal MI at the end of one year 4) Clinically Driven Target vessel revascularisation at the end of one year 5) Stroke ( both hemorrhagic and ischemic ) at the end of one year 6) All cause mortality at the end of one year 7) Non cardiac cause of death at the end of one year.Timepoint: During study period

Countries

India

Contacts

Public ContactSunitha Viswanathan

Department of Cardiology, Government Medial College, Thiruvanathapuram, Kerala

kirangopinathpanicker@gmail.com09349454470

Outcome results

None listed

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