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

Primary Purpose

Coronary Artery Disease, Diabetes Mellitus

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Polymer-Based Everolimus-Eluting Stent
Polymer-Free Amphilimus-Eluting Stent
Sponsored by
Spanish Society of Cardiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous coronary intervention, Drug eluting stent, Neointimal hyperplasia, Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínic i Provincial
  • Hospital Universitari de Bellvitge
  • Hospital Clínico San Carlos
  • Hospital Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Polymer-Based Everolimus-Eluting Stent

Polymer-Free Amphilimus-Eluting Stent

Arm Description

Polymer-Based Everolimus-Eluting Stent

Reservoir-Based Polymer-Free Amphilimus-Eluting Stent

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Cardiac death
Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac.
Probable or definite stent thrombosis
Stent thrombosis is considered according to the Academic Research Consortium definitions
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.

Full Information

First Posted
October 17, 2012
Last Updated
November 5, 2013
Sponsor
Spanish Society of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT01710748
Brief Title
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients
Acronym
RESERVOIR
Official Title
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spanish Society of Cardiology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes Mellitus
Keywords
Percutaneous coronary intervention, Drug eluting stent, Neointimal hyperplasia, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polymer-Based Everolimus-Eluting Stent
Arm Type
Active Comparator
Arm Description
Polymer-Based Everolimus-Eluting Stent
Arm Title
Polymer-Free Amphilimus-Eluting Stent
Arm Type
Experimental
Arm Description
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Intervention Type
Device
Intervention Name(s)
Polymer-Based Everolimus-Eluting Stent
Other Intervention Name(s)
Xience Coronary Stent System
Intervention Description
Polymer-Based Everolimus-Eluting Stent
Intervention Type
Device
Intervention Name(s)
Polymer-Free Amphilimus-Eluting Stent
Other Intervention Name(s)
Cre8 Coronary Stent System
Intervention Description
Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
Primary Outcome Measure Information:
Title
Neointimal hyperplasia volume obstruction
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Percentage of uncovered struts
Description
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.
Time Frame
9 months
Title
Percentage of malapposed struts
Description
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.
Time Frame
9 months
Title
Maximum percentage of NIH cross-sectional obstruction
Description
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.
Time Frame
9 months
Title
Cardiac death
Description
Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac.
Time Frame
12 months
Title
Probable or definite stent thrombosis
Description
Stent thrombosis is considered according to the Academic Research Consortium definitions
Time Frame
12 months
Title
Target vessel failure
Description
Target vessel failure is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated revascularization of the target vessel.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Romaguera, MD
Organizational Affiliation
Spanish Society of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic i Provincial
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26762910
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.
Results Reference
derived
PubMed Identifier
25380051
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.
Results Reference
derived

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

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