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

Spanish Society of Cardiology

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Disease; Diabetes Mellitus

Treatments: Device: Polymer-Based Everolimus-Eluting Stent; Device: Polymer-Free Amphilimus-Eluting Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01710748

SEC-RES-2012-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

Polymer-Based Everolimus-Eluting Stent

Active Comparator group

Description:

Polymer-Based Everolimus-Eluting Stent

Treatment:

Device: Polymer-Based Everolimus-Eluting Stent

Polymer-Free Amphilimus-Eluting Stent

Experimental group

Description:

Reservoir-Based Polymer-Free Amphilimus-Eluting Stent

Treatment:

Device: Polymer-Free Amphilimus-Eluting Stent