A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV Institute (Maximus)
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.
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.
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.
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)
|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|
- 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 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 ]
|Study Start Date:||July 2006|
|Study Completion Date:||March 2008|
|Max Heart and Vascular Institute|
|New Delhi, India, 110017|
|Principal Investigator:||Dr. Ashok Seth||Escorts Heart Institute & Research Centre|