- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01710748
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR)
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
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Barcelona, Spain
- Hospital Clinic I Provincial
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Barcelona, Spain
- Hospital Universitari de Bellvitge
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Madrid, Spain
- Hospital Clínico San Carlos
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Murcia, Spain
- Hospital Virgen de la Arrixaca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Polymer-Based Everolimus-Eluting Stent
Other Names:
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Experimental: Polymer-Free Amphilimus-Eluting Stent
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
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Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Other Names:
|
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
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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.
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9 months
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Cardiac death
Time Frame: 12 months
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Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac.
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12 months
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Probable or definite stent thrombosis
Time Frame: 12 months
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Stent thrombosis is considered according to the Academic Research Consortium definitions
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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.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rafael Romaguera, MD, Spanish Society of Cardiology
Publications and helpful links
General Publications
- Romaguera R, Gomez-Hospital JA, Gomez-Lara J, Brugaletta S, Pinar E, Jimenez-Quevedo P, Gracida M, Roura G, Ferreiro JL, Teruel L, Montanya E, Fernandez-Ortiz A, Alfonso F, Valgimigli M, Sabate M, Cequier A. A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus: The RESERVOIR Clinical Trial. JACC Cardiovasc Interv. 2016 Jan 11;9(1):42-50. doi: 10.1016/j.jcin.2015.09.020.
- Romaguera R, Brugaletta S, Gomez-Lara J, Pinar E, Jimenez-Quevedo P, Gracida M, Roura G, Ferreiro JL, Teruel L, Gomez-Hospital JA, Montanya E, Alfonso F, Valgimigli M, Sabate M, Cequier A. Rationale and study design of the RESERVOIR trial: a randomized trial comparing reservoir-based polymer-free amphilimus-eluting stents versus everolimus-eluting stents with durable polymer in patients with diabetes mellitus. Catheter Cardiovasc Interv. 2015 Mar;85(4):E116-22. doi: 10.1002/ccd.25728. Epub 2014 Nov 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Coronary Disease
- Coronary Artery Disease
- Diabetes Mellitus
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Everolimus
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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