Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients
- Conditions
- Coronary Artery DiseaseDiabetes Mellitus
- Interventions
- Device: Polymer-Based Everolimus-Eluting StentDevice: Polymer-Free Amphilimus-Eluting Stent
- Registration Number
- NCT01710748
- Lead Sponsor
- Spanish Society of Cardiology
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polymer-Based Everolimus-Eluting Stent Polymer-Based Everolimus-Eluting Stent Polymer-Based Everolimus-Eluting Stent Polymer-Free Amphilimus-Eluting Stent Polymer-Free Amphilimus-Eluting Stent Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
- Primary Outcome Measures
Name Time Method Neointimal hyperplasia volume obstruction 9 months 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
Name Time Method Percentage of uncovered struts 9 months 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.
Cardiac death 12 months 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 12 months Stent thrombosis is considered according to the Academic Research Consortium definitions
Target vessel failure 12 months Target vessel failure is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated revascularization of the target vessel.
Percentage of malapposed struts 9 months 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 9 months 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.
Trial Locations
- Locations (4)
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Clínic i Provincial
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital Virgen de la Arrixaca
🇪🇸Murcia, Spain