The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.
This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 months, and 48 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Erasmus Centrum Thoraxcentrum
Rotterdam, Netherlands
Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.
Time frame: post procedure and 6 months
Assessment of lesion morphology by intravascular ultrasound (IVUS).
Time frame: post procedure and 6 months
Target vessel failure (TVF).
Time frame: 6 months
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