The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
109
Eastern Heart Clinic - Prince of Wales Hospital
Sydney, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
St. Andrew's Hospital
Adelaide, South Australia, Australia
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
Time frame: 9 months
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Royal Adelaide Hospital
Adelaide, Australia
Wesley Hospital / HeartCare Partners
Auchenflower, Australia
Flinders Medical Center
Bedford Park, Australia
St. Vincent's Hospital
Darlinghurst, Australia
Royal Brisbane & Women's Hospital
Herston, Australia
Monash Medical Center
Melbourne, Australia
Northern Hospital
Melbourne, Australia
...and 5 more locations