Coronary Artery Disease Clinical Trial
Official title:
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial
This study is a prospective, randomized controlled, single blind, two-arm, multicenter
clinical evaluation.
Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of
the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)
Polymer-Based Everolimus-Eluting Stent.
The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent
implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based
Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as
the primary imaging modality.
In patients with diabetes mellitus (DM), drug eluting stents (DES) have been shown to be
associated with greater neointimal suppression than bare-metal stents. However, there is an
ongoing debate on the optimal drug-eluting stent in diabetic patients.
This study is a prospective, randomized controlled, single blind, two-arm, multicenter
clinical evaluation.
Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of
the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2)
Polymer-Based Everolimus-Eluting Stent.
The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent
implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based
Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as
the primary imaging modality.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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