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Sponsored by: |
Sahajanand Medical Technologies Pvt. Ltd. |
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Information provided by: | Sahajanand Medical Technologies Pvt. Ltd. |
ClinicalTrials.gov Identifier: | NCT00811616 |
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
The following secondary safety endpoints were assessed:
Condition | Intervention |
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Coronary Artery Disease |
Device: Supralimus-Core™ |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 105 |
Study Start Date: | July 2006 |
Study Completion Date: | March 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Angiographic Exclusion criteria:
India | |
Max Heart and Vascular Institute | |
New Delhi, India, 110017 |
Principal Investigator: | Dr. Ashok Seth | Escorts Heart Institute & Research Centre |
Responsible Party: | Sahajanand Medical Technologies Pvt. Ltd ( Mr. J.P. Dutta ) |
Study ID Numbers: | The MAXIMUS study |
Study First Received: | December 18, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00811616 History of Changes |
Health Authority: | India: Institutional Review Board |
Coronary artery disease Supralimus-Core™ de novo native coronary artery lesion |
Arterial Occlusive Diseases Sirolimus Anti-Infective Agents Heart Diseases Immunologic Factors Chromium Myocardial Ischemia Vascular Diseases |
Ischemia Arteriosclerosis Immunosuppressive Agents Coronary Disease Anti-Bacterial Agents Cobalt Antifungal Agents Coronary Artery Disease |
Arterial Occlusive Diseases Sirolimus Anti-Infective Agents Heart Diseases Immunologic Factors Antineoplastic Agents Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Arteriosclerosis |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Coronary Disease Anti-Bacterial Agents Antifungal Agents Therapeutic Uses Cardiovascular Diseases Coronary Artery Disease |