Coronary Artery Disease Clinical Trial
Official title:
A Randomized Comparison of Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions: The Gruppo Italiano di Studio Sullo Stent Nelle Occlusioni Coronariche. The GISSOC II Study.
The objective of this study is to compare the Cypher Select-TM Sirolimus Eluting Stent (SES) with the SONIC-TM Bare Metal Stent (BMS) in the treatment of Chronic Total Occlusion lesions (CTO). The primary hypothesis is that, at 8-month follow-up, the minimal luminal diameter (MLD) of the coronary segment treated with stent implantation in CTO lesions is significantly larger with the use of SES compared to BMS. The treated segment is defined as the segment covered by the stent(s) plus 5 mm proximally and distally to the stent(s).
This is a multicenter, prospective, randomized study that will be conducted at up to 22
centers in Italy. All patients who meet the eligibility criteria will be randomized to
Cypher Select-TM Stent or SONIC-TM Stent. Patients will have repeat angiography at 8 months
and clinical follow-up to 2 years. The study population will consist of 150 patients with
single chronic total occlusion in a native coronary artery with a reference diameter between
2.75 mm and 3.75 mm. The occlusion has to be dilatable by balloon angioplasty and can be
fully covered by < 2 stents of ≤33 mm of length each. The CTO is defined as obstruction of a
native coronary artery, at least 30 days old, with no luminal continuity and with
Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 or 1. Following confirmation of
eligibility criteria and successful pre-dilating of the CTO, patients will be randomized in
a 1:1 ratio to receive SES CYPHER SELECT Stent or BMS SONIC Stent.
The coronary angiograms will be assessed at a core laboratory with Quantitative Coronary
Angiography. Quantitative angiographic parameters including minimal luminal diameter, binary
restenosis rate, total reocclusion rate, late luminal loss, will be evaluated at 8 months.
The incidence of clinical events, including death, myocardial infarction, target vessel
revascularization, stent thrombosis, will be evaluated at 8, 12 and 24 months.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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