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

Coronary Artery Disease Clinical Trial

— RESERVOIR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01710748
• Other study ID #: SEC-RES-2012-01
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 17, 2012
• Last updated: November 5, 2013
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: November 2013
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Device:
• Polymer-Based Everolimus-Eluting Stent
Polymer-Based Everolimus-Eluting Stent
• Polymer-Free Amphilimus-Eluting Stent
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Virgen de la Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of uncovered struts	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	Yes
Secondary	Percentage of malapposed struts	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	Yes
Secondary	Maximum percentage of NIH cross-sectional obstruction	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	No
Secondary	Cardiac death	Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac.	12 months	Yes
Secondary	Probable or definite stent thrombosis	Stent thrombosis is considered according to the Academic Research Consortium definitions	12 months	Yes
Secondary	Target vessel failure	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	No