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Observational study to see the results of stent used for restoration of blood supply in in patients with Heart Disease

A Retrospective, Investigator initiated, Multicentric, Data Collection Study to Evaluate the Performance of Made in India Espalier Everolimus Drug Eluting Stent used for Coronary revascularization - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/084721
Enrollment
500
Registered
2025-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: I249- Acute ischemic heart disease, unspecified

Interventions

Intervention1: Indigenous Espalier (Everolimus Drug Eluting Stent: PCI stent Intervention2: NIL: NIl

Sponsors

Cognetive Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender and aged above 18 years 2. Patients with Unstable Angina (UA)/stable ischemic heart disease (SIHD)/ NSTEMI /STEMI suitable for angiography /angioplasty 3. Patients with single or multi-vessel lesions in native vessels, undergoing one point/staged multi vessel PTCA. 4. Patients whose medical records available for pre post procedure (Baseline) 30 days 6 and 12 months clinical follow up in the Medical Records Sections

Exclusion criteria

Exclusion criteria: 1. Hemodynamic instability or cardiogenic shock patients 2. Contraindication for dual antiplatelet therapy (DAPT) 3. Lesions with in-stent re-stenosis /thrombosis in other stents 4. Patients whose follow up uptill 1 year is not available

Design outcomes

Primary

MeasureTime frame
Target Lesion Failure (TLF) at 30 days, 6 months, 12 months- Composite of cardiac death/admission due to target lesion Q-wave or non-Q wave Myocardial Infarction (MI), Target Lesion Revascularization (Re PTCA/CABG).Timepoint: 30 days, 6 months, 12 months-—

Secondary

MeasureTime frame
1 Acute & Sub acute Stent Thrombosis uptill 30 days 2 In stent stenosis up till 6 months & 1 year 3 Impact of Diabetes Mellitus/ Chronic Kidney Disease on outcomesTimepoint: 30 days 6 months 12 months—

Countries

India

Contacts

Public ContactDeepti Goel

Harrison Tech Consultants

deepti.goel@harrisonstechconsultants.com9910906014

Outcome results

None listed

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