Overview

This trial is active, not recruiting.

Conditions coronary artery disease, diabetes mellitus
Treatments polymer-based everolimus-eluting stent, polymer-free amphilimus-eluting stent
Phase phase 3
Sponsor Spanish Society of Cardiology
Start date October 2012
End date July 2014
Trial size 112 participants
Trial identifier NCT01710748, SEC-RES-2012-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Polymer-Based Everolimus-Eluting Stent
polymer-based everolimus-eluting stent Xience Coronary Stent System
Polymer-Based Everolimus-Eluting Stent
(Experimental)
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
polymer-free amphilimus-eluting stent Cre8 Coronary Stent System
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent

Primary Outcomes

Measure
Neointimal hyperplasia volume obstruction
time frame: 9 months

Secondary Outcomes

Measure
Percentage of uncovered struts
time frame: 9 months
Percentage of malapposed struts
time frame: 9 months
Maximum percentage of NIH cross-sectional obstruction
time frame: 9 months
Cardiac death
time frame: 12 months
Probable or definite stent thrombosis
time frame: 12 months
Target vessel failure
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial
Principal investigator Rafael Romaguera, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Spanish Society of Cardiology.