The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the bare metal Bx VELOCITY balloon-expandable stent. Both stents will be mounted on the Raptor Rapid Exchange Delivery Stent System.
This is a multicenter (19 sites), prospective, randomized study. This study has a 2 arm design assessing the safety and effectiveness of the sirolimus coated BxTM VELOCITY stent to the bare metal BxTM VELOCITY stent, both mounted on the Raptorâ Rapid Exchange Stent Delivery System. A total of 220 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be randomized to the coated or uncoated BX VELOCITY stent. Therefore, neither the Investigator nor the patient will know which stent will be implanted. Patients will be followed for twelve months post-procedure, with all patients having a repeat angiography at 6 months. An ancillary study with in-stent IVUS measurements at 6 months follow-up will be performed in all patients of 6 pre-selected clinical sites. It is assumed that these sites will enroll more than 90 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
drug-eluting stent
bare-metal stent
Dr Marie-Claude Morice
Massy, France
Angiographic in-stent late loss as determined by Quantitative Coronary Angiography.
Time frame: 6 months follow-up
In-stent mean %DS by QCA
Time frame: post-procedure
In-target vessel segment MLD
Time frame: 6 months
In-stent MLD
Time frame: 6 months
Target Lesion Revascularization
Time frame: 6 and 12 months; or 2, 3, 4 and 5 years
Target Vessel Revascularization
Time frame: 6 and 12 months; or 2, 3, 4 and 5 years
Major Adverse Cardiac Events
Time frame: 30 days; 6 and 12 months; or 2, 3, 4 and 5 years;
Neo-intimal growth assessed by IVUS
Time frame: 6 months
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