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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial

Conditions
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Coronary Artery Disease, Diabetes Mellitus

Intervention / Treatment
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* Device: Polymer-Based Everolimus-Eluting Stent
* Device: Polymer-Free Amphilimus-Eluting Stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polymer-Based Everolimus-Eluting Stent<br>Polymer-Based Everolimus-Eluting Stent | Device: Polymer-Based Everolimus-Eluting Stent<br>* Polymer-Based Everolimus-Eluting Stent<br>* Other names: Xience Coronary Stent System;|
| Experimental: Polymer-Free Amphilimus-Eluting Stent<br>Reservoir-Based Polymer-Free Amphilimus-Eluting Stent | Device: Polymer-Free Amphilimus-Eluting Stent<br>* Reservoir-Based Polymer-Free Amphilimus-Eluting Stent<br>* Other names: Cre8 Coronary Stent System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal hyperplasia volume obstruction | The primary endpoint is assessed by Optical Coherence Tomography. It is defined as neointimal hyperplasia volume (mm3) divided by the stent volume multiplied by 100. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of uncovered struts | This endpoint is assessed by Optical Coherence Tomography. Struts are classified as uncovered if any part of the strut is visibly exposed to the lumen, or covered if a layer of tissue is visible over all the reflecting surfaces. | 9 months | 
| Percentage of malapposed struts | This endpoint is assessed by Optical Coherence Tomography. Apposition is assessed strut by strut by measuring the distance between the strut marker and the lumen contour. Struts with distance to lumen contour larger than the sum of strut + polymer thickness are considered malapposed. This results in incomplete strut apposition thresholds of 89 µm for the Xience Prime and 80 µm for the Cre8 stent. Struts located at the ostium of side branches, with no vessel wall behind, are excluded from the analysis of apposition. | 9 months | 
| Maximum percentage of NIH cross-sectional obstruction | This endpoint is assessed by Optical Coherence Tomography. Percentage of NIH cross-sectional obstruction is defined as the NIH area (mm2) divided by the stent area multiplied by 100. | 9 months | 
| Cardiac death | Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac. | 12 months | 
| Probable or definite stent thrombosis | Stent thrombosis is considered according to the Academic Research Consortium definitions | 12 months | 
| Target vessel failure | Target vessel failure is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated revascularization of the target vessel. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Drug eluting stent, Neointimal hyperplasia, Diabetes Mellitus