Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients

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.

Clinical Inclusion Criteria:

• Subject is eligible for PCI.
• Subject has symptomatic coronary artery disease (stable/unstable angina or Non-ST elevation myocardial infarction).
• Subject has known DM.

Angiographic Inclusion Criteria:

• Presence of 1 or 2 de novo native coronary artery lesions (maximum 1 lesion per epicardial coronary artery), with a visual estimation stenosis ≥ 50%.
• Target lesion length 12-25mm, reference diameter 2.5-3.5mm.

Clinical Exclusion Criteria:

• ST-segment elevation myocardial infarction <48h
• Presence of cardiogenic shock pre-procedure
• Contra-indications to dual antiplatelet therapy for 12 months
• Left Ventricular Ejection Fraction ≤30%
• GFR<30 ml/min/m2
• Target vessel has been treated previously
• Platelet count <75000/mm3 or >700000/mm3
• Immunosuppressive therapy
• Has received or waiting list for any transplant
• Life-threatening disease with a life expectancy of < 12 months
• Pregnant or breast feeding patient
• Inability to provide informed consent

Angiographic Exclusion Criteria:

• TIMI flow ≤ 1 prior to guide wire crossing
• There is an additional lesion within the target vessel planned to be treated within the next 12 months
• Target vessel is a saphenous vein graft
• Target vessel is the left main, ostial LAD and/or ostial LCX.
• Prior PCI of the target lesion (restenosis)
• Lesion cannot be covered by a single stent (unplanned bailout stenting is allowed)
• Involved side branch ≥2.5mm by visual estimation
• Rotablator, ELCA or brachytherapy
• Severe calcification of target lesion