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

November 5, 2013 updated by: Dr Rafael Romaguera, Spanish Society of Cardiology

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Clinic i Provincial
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Polymer-Based Everolimus-Eluting Stent
Device: Polymer-Based Everolimus-Eluting Stent
Polymer-Based Everolimus-Eluting Stent
Other Names:
  • Xience Coronary Stent System
Experimental: Polymer-Free Amphilimus-Eluting Stent
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Device: Polymer-Free Amphilimus-Eluting Stent
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Other Names:
  • Cre8 Coronary Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neointimal hyperplasia volume obstruction
Time Frame: 9 months
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
Time Frame: 9 months
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
Time Frame: 9 months
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
Time Frame: 9 months
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
Time Frame: 12 months
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
Time Frame: 12 months
Stent thrombosis is considered according to the Academic Research Consortium definitions
12 months
Target vessel failure
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Society of Cardiology

Investigators

  • Principal Investigator: Rafael Romaguera, MD, Spanish Society of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 19, 2012

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEC-RES-2012-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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