Clinical trial NCT01710748: Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients
Official title: Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Diabetes Mellitus
Keywords: Percutaneous coronary intervention
Drug eluting stent
Neointimal hyperplasia
Diabetes Mellitus
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neointimal hyperplasia volume obstruction
timeFrame: 9 months
Secondary outcomes:
measure: Percentage of uncovered struts
timeFrame: 9 months
measure: Percentage of malapposed struts
timeFrame: 9 months
measure: Maximum percentage of NIH cross-sectional obstruction
timeFrame: 9 months
measure: Cardiac death
timeFrame: 12 months
measure: Probable or definite stent thrombosis
timeFrame: 12 months
measure: Target vessel failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
Study officials:
affiliation: Spanish Society of Cardiology
name: Rafael Romaguera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.