Coronary Artery Disease Clinical Trial
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
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)
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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