Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients
RESERVOIR
1 other identifier
interventional
112
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 coronary-artery-disease
Started Oct 2012
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 17, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 6, 2013
November 1, 2013
1.7 years
October 17, 2012
November 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neointimal hyperplasia volume obstruction
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 Outcomes (6)
Percentage of uncovered struts
9 months
Percentage of malapposed struts
9 months
Maximum percentage of NIH cross-sectional obstruction
9 months
Cardiac death
12 months
Probable or definite stent thrombosis
12 months
- +1 more secondary outcomes
Study Arms (2)
Polymer-Based Everolimus-Eluting Stent
ACTIVE COMPARATORPolymer-Based Everolimus-Eluting Stent
Polymer-Free Amphilimus-Eluting Stent
EXPERIMENTALReservoir-Based Polymer-Free Amphilimus-Eluting Stent
Interventions
Polymer-Based Everolimus-Eluting Stent
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Eligibility Criteria
You may qualify if:
- Subject is eligible for PCI.
- 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.
You may not qualify if:
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
Related Publications (2)
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.
PMID: 26762910DERIVEDRomaguera 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.
PMID: 25380051DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Romaguera, MD
Spanish Society of Cardiology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Rafael Romaguera
Study Record Dates
First Submitted
October 17, 2012
First Posted
October 19, 2012
Study Start
October 1, 2012
Primary Completion
July 1, 2014
Study Completion
October 1, 2014
Last Updated
November 6, 2013
Record last verified: 2013-11