E-SERIES Registry: Supralimus(R) and Supralimus-Core(TM) Cardiac Stents for the Treatment of Coronary Artery Blockage.

E-SERIES Registry: A Prospective and Retrospective, Multinational Investigation of the Supralimus(R) and Supralimus-Core(TM) Sirolimus-Eluting Stents for the Treatment of Unselected Patients with Coronary Lesions in the Real-World Clinical Practice

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2009/091/000407

Enrollment

3000

Registered

2009-07-06

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- Coronary Artery Disease

Interventions

Intervention1: Supralimus(R) and Supralimus-Core(TM) Sirolimus Eluting Coronary Stent System: 1.4 &micro

g/mm2 Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical inclusion criteria: Patients all comers for routine or emergency percutaneous coronary intervention with grater then 18 years of age. 2. Angiographic inclusion criteria: Diseased coronary vessels with at least one lesion with grater then or equle to 50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (grater then 2.25mm) with anatomy suitable for percutaneous treatment with implantation of the Supralimus(R) and Supralimus-Core(TM) SES

Exclusion criteria

Exclusion criteria: 1. Clinical exclusion criteria: Known illness with life expectancy less then 12 months, and impossibility to comply with all study protocol follow-ups. 2. Angiographic exclusion criteria: Coronary anatomy unsuitable for percutaneous treatment with implantation of the Supralimus(R) or Supralimus-Core(TM) SES.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Rates of major adverse cardiac events (MACE) at 12 months clinical follow-up after implantation of the Supralimus(R) or Supralimus-Core(TM) SES at index procedure.Timepoint: 12 Months	—

Secondary

Measure	Time frame
Rates of procedural success, Rates of MACE at: in-hospital (post-stent implantation), and at 30 days, 6 and 24 months clinical follow-up, Rates of target lesion revascularization(TLR)at 6 and 12 months, Rates of stent thrombosis up to 24 months follow-upTimepoint: Follow-Up: 1,6,12 and 24 Month	—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

atulda@hotmail.com91-261-2254888

Outcome results

None listed

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