Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients
Spain112 participantsStarted 2012-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Rotablato…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.