The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.
This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions \<23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
CYPHER™ Sirolimus-eluting Coronary Stent
Cardiothoracic Center Liverpool
Liverpool, United Kingdom
Angiographic in-stent late loss
Time frame: 6 months
In-stent mean percent diameter stenosis
Time frame: anytime post-procedure
In-target vessel segment MLD
Time frame: 6 months
In-stent MLD
Time frame: 6 months
Target Lesion Revascularization (TLR)
Time frame: 6 months
Target Vessel Revascularization (TVR)
Time frame: 6 months
Major Adverse Cardiac Events (MACE)
Time frame: 30 days, 6 and 12 months
In-stent volume of restenosis determined by IVUS
Time frame: 6 months
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