Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation (NCT03214900) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation
20 participantsStarted 2012-07-01
Plain-language summary
This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent implantation with everolimus eluting stent will be include. The primary endpoint was the correlation between the change (baseline vs. 1 week) in the number of circulating endothelial progenitor cells and in cell functionality following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence tomography
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.
Inclusion Criteria:
* Patients who present stable angina, silent ischemia or unstable angina whenever there is no elevation of markers of myocardial damage above the limit of normality
* Presence of at least one severe coronary stenosis (\> 70% by visual analysis), susceptible of percutaneous treatment with stent implantation and an optical coherence Tomography study
* All patients should be taking statins at least 2 months prior to their inclusion in the study.
Exclusion Criteria:
* Age under 18 years and pregnant or fertile age,
* Patients with ST-elevation myocardial infarction or non-ST-elevation acute coronary syndrome with markers of recent myocardial damage (\<3 months),
* Patients in whom a drug-eluting stent and a bare stent have been implanted in the same procedure.
* Percutaneous treatment of restenotic lesions or total chronic occlusions.
* The use of stent pre-implantation ablation techniques (rotablator, directional atherectomy).
* Chronic renal insufficiency with serum creatinine greater than or equal to 2.5.
* Coronary revascularization in previous 3 months.
* Severe ventricular dysfunction (\<25%).
* Major trauma or surgery in the previous 3 months.
* Previous organ transplantation, active neoplastic process or inflammatory disease, treatment with immunosuppressors.
* Contraindication or allergy to thienopyridines.
* Life expectancy less than one year.
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.
What they're measuring
1
The correlation between the change (baseline vs 1 week) of circulating with neointimal hyperplasia endothelial progenitor cells and in cell functionality following an Everolimus eluting stent implantation with the grade of neointimal hyperplasia