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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Supralimus-Core™
Sponsored by
Sahajanand Medical Technologies Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Supralimus-Core™, de novo native coronary artery lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%;

Sites / Locations

  • Max Heart and Vascular Institute

Outcomes

Primary Outcome Measures

Primary safety endpoint: Major Adverse Cardiac Events (MACE)
Primary efficacy endpoint: In-stent binary restenosis rate determined by off-line Quantitative Coronary Angiography.

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)
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

Full Information

First Posted
December 18, 2008
Last Updated
May 10, 2010
Sponsor
Sahajanand Medical Technologies Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00811616
Brief Title
A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV Institute
Acronym
Maximus
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sahajanand Medical Technologies Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, Supralimus-Core™, de novo native coronary artery lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Supralimus-Core™
Intervention Description
Sirolimus Eluting Cobalt Chromium based coronary stent system
Primary Outcome Measure Information:
Title
Primary safety endpoint: Major Adverse Cardiac Events (MACE)
Time Frame
30 days
Title
Primary efficacy endpoint: In-stent binary restenosis rate determined by off-line Quantitative Coronary Angiography.
Time Frame
8 Month
Secondary Outcome Measure Information:
Title
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)
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Ashok Seth
Organizational Affiliation
Escorts Heart Institute & Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max Heart and Vascular Institute
City
New Delhi
ZIP/Postal Code
110017
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
23253405
Citation
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.
Results Reference
derived

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

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