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CompletedNCT00811616MaximusUpdated May 16, 2025

A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV Institute

An interventional study of Supralimus-Core™ and Supralimus™ Core™ Sirolimus eluting stent in Coronary Artery Disease, sponsored by Sahajanand Medical Technologies Limited. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Sahajanand Medical Technologies Limited · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

OBJECTIVES:

The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease.

STUDY DESIGN:

This is a single centre, prospective study. Approximately 105 patients were enrolled in the study. Patients were followed for twelve months post-procedure. All patients were to have a repeat angiography at 8 months.

STUDY POPULATION:

The study population consisted of approximately 105 patients with de novo native vessel obstructive coronary artery disease with no specific criteria. Patients from the daily practice were included. Patients had to meet all eligibility criteria for inclusion into the study.

ENDPOINTS:

The primary safety endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at 30 days.

The primary efficacy endpoint is the in-stent binary restenosis rate at 8-month follow-up determined by off-line Quantitative Coronary Angiography.

The following secondary efficacy endpoints were assessed

  • Angiographic success
  • Procedure success
  • Quantitative Coronary Angiography derived vessel parameters in-stent and 5 mm proximal and 5 mm distal from the edge of the stent: acute gain, MLD, % DS, late loss, mean diameter. In-stent pre-, post and at 8-month follow-up.
  • Clinically justified Target Lesion Revascularization (TLR) at 12 months

The following secondary safety endpoints were assessed:

  • MACE until 12 months
  • Device related SAEs until 12 months
  • Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12 months)
02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary artery disease
  • Supralimus-Core™
  • de novo native coronary artery lesion
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 105 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Sahajanand Medical Technologies Limited is the lead sponsor of 12 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The patient must be >= 18 years of age;
  • Symptomatic ischemic heart disease (CCS class 1 -4 , Braunwald class IB, IC, IIB, IIC, IIIB,IIIC) and/or objective evidence of myocardial ischemia;
  • Vessel size of >= 2.5 and \<= 3.5mm.
  • Target lesions which can be covered by stent in a manner lesion stent ratio of at least 1.5.
  • Acceptable candidate for coronary artery bypass surgery (CABG);
  • Target lesion stenosis is >50% and \<100% (TIMI flow I) (visual estimate);
  • The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB).

Exclusion criteria

Exclusion Criteria:

  • Women of childbearing potential;
  • Impaired renal function (creatinine > 2.0 mg/dl or 177 µmol/l);
  • Any patient who has a platelet count \< 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis);
  • Recipient of heart transplant;
  • Restenotic or lesion in graft.
  • Patient with a life expectancy less than 12 months;
  • Known allergies to aspirin, clopidogrel bisulphate (Plavix), ticlopidine (Ticlid), heparin or stainless steel;
  • Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
  • Currently participating in an investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow-up.

Angiographic Exclusion criteria:

  • Unprotected left main coronary artery disease with >=50% stenosis;
  • Angiographic evidence of thrombus (thrombus larger than half the diameter of the vessel and/or requiring other interventions such as angiojet, exciser, thrombolysis, etc.);
  • Ejection fraction \<= 30%;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Supralimus™ Core™ Sirolimus eluting stent

    Supralimus™ Core™ Sirolimus eluting stent manufactured by Sahajanand Medical Technologies Limited intended to treat coronary artery disease.

    Device: Supralimus-Core™ · Device: Supralimus™ Core™ Sirolimus eluting stent

Interventions

  • DeviceSupralimus-Core™

    Sirolimus Eluting Cobalt Chromium based coronary stent system

  • DeviceSupralimus™ Core™ Sirolimus eluting stent

    Supralimus™ Core™ Sirolimus eluting stent intended to treat coronary artery disease.

06

What researchers measure

Primary outcomes

  1. Primary safety endpoint: Major Adverse Cardiac Events (MACE)

    Time frame: 30 days

  2. Primary efficacy endpoint: In-stent binary restenosis rate determined by off-line Quantitative Coronary Angiography.

    Time frame: 8 Month

Secondary outcomes

  1. Secondary safety endpoints: - MACE until 12 months, Device related SAEs until 12 months, Angiographic stent thrombosis: Subacute (after procedure until 30 days) and Late (after 30 days until 12 months)

    Time frame: 12 months

  2. Secondary efficacy endpoints: Angiographic, Procedure success; acute gain, MLD, % DS, LL, mean diameter; In-stent pre-,post,8-month follow-up; Clinically justified TLR at 12 months

    Time frame: 12 months

07

Study locations

1 site
  • Max Heart and Vascular Institute
    New Delhi, 110017, India
08

References and documents

Publications

  • Seth A, Chandra P, Chouhan NS, Thakkar AS. A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients. Indian Heart J. 2012 Nov-Dec;64(6):547-52. doi: 10.1016/j.ihj.2012.07.011. Epub 2012 Jul 27. PubMed 23253405 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00811616
Lead sponsor
Sahajanand Medical Technologies Limited
Responsible party
Sponsor
First posted
Dec 19, 2008
Start date
Jul 2006
Primary completion
Jul 2007
Completion
Mar 2008
Last update
May 16, 2025

Study contacts

Dr. Ashok Seth
principal investigator · Escorts Heart Institute & Research Centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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