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

This study has been completed.
Sponsor:
Information provided by:
Sahajanand Medical Technologies Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT00811616
First received: December 18, 2008
Last updated: May 10, 2010
Last verified: May 2010
  Purpose

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)

Condition Intervention
Coronary Artery Disease
Device: Supralimus-Core™

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety And Efficacy Evaluation of Sirolimus Eluting Supralimus-Core™ Stent at MAX DDHV Institute in the Treatment of de Novo Native Coronary Artery Lesions

Resource links provided by NLM:


Further study details as provided by Sahajanand Medical Technologies Pvt. Ltd.:

Primary Outcome Measures:
  • Primary safety endpoint: Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Primary efficacy endpoint: In-stent binary restenosis rate determined by off-line Quantitative Coronary Angiography. [ Time Frame: 8 Month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: Yes ]

Enrollment: 105
Study Start Date: July 2006
Study Completion Date: March 2008
Intervention Details:
    Device: Supralimus-Core™
    Sirolimus Eluting Cobalt Chromium based coronary stent system
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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%;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811616

Locations
India
Max Heart and Vascular Institute
New Delhi, India, 110017
Sponsors and Collaborators
Sahajanand Medical Technologies Pvt. Ltd.
Investigators
Principal Investigator: Dr. Ashok Seth Escorts Heart Institute & Research Centre
  More Information

No publications provided by Sahajanand Medical Technologies Pvt. Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mr. J.P. Dutta, Sahajanand Medical Technologies Pvt. Ltd
ClinicalTrials.gov Identifier: NCT00811616     History of Changes
Other Study ID Numbers: The MAXIMUS study
Study First Received: December 18, 2008
Last Updated: May 10, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Sahajanand Medical Technologies Pvt. Ltd.:
Coronary artery disease
Supralimus-Core™
de novo native coronary artery lesion

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 23, 2014