Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients
NCT ID: NCT01710748
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
112 participants
INTERVENTIONAL
2012-10-31
2014-10-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Polymer-Based Everolimus-Eluting Stent
Polymer-Based Everolimus-Eluting Stent
Polymer-Based Everolimus-Eluting Stent
Polymer-Based Everolimus-Eluting Stent
Polymer-Free Amphilimus-Eluting Stent
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Polymer-Free Amphilimus-Eluting Stent
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Interventions
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Polymer-Based Everolimus-Eluting Stent
Polymer-Based Everolimus-Eluting Stent
Polymer-Free Amphilimus-Eluting Stent
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has symptomatic coronary artery disease (stable/unstable angina or Non-ST elevation myocardial infarction).
* Subject has known DM.
* 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.
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Spanish Society of Cardiology
OTHER
Responsible Party
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Dr Rafael Romaguera
Dr. Rafael Romaguera
Principal Investigators
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Rafael Romaguera, MD
Role: PRINCIPAL_INVESTIGATOR
Spanish Society of Cardiology
Locations
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Hospital Clínic i Provincial
Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Barcelona, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Virgen de la Arrixaca
Murcia, Murcia, Spain
Countries
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References
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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.
Other Identifiers
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SEC-RES-2012-01
Identifier Type: -
Identifier Source: org_study_id