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OpenTrials
Completed

NCT Number: NCT03214900

Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation

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

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Key information

About this study

For the purpose of the study, flow cytometry analyses will be performed before intervention, at 1 week, 1 month and 9 months. In addition, cell functionality analyses will be performed by quantification of colony forming units, aldehidrodehidrogenase activity, cell proliferation by WST-1 and senescence by !-galactosidase enzyme. At 9 months the degree of neointimal proliferation will be measured by optical coherence tomography . A clinical follow-up will be performed at 1 year. Secondary endpoints include: 1. to correlate the change in the number and cell functionality of circulation progenitor cells following everolimus eluting stent and the injury score analyses measured by optical coherence tomography, and the percentage of non covered struts by optical coherence tomography at 9 months.

2.-. To evaluate the role of other subtypes of cells CD 133+/Kinase Insert Domain Receptor (KDR+), CD 14+, mesenchymal stem cells, endothelial cell markers (VE cadherina, P1H12), integrin expression of Macrophage-1 antigen (MAC-1) and the development of neointimal hyperplasia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

    Time frame: 9 months

    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

Secondary outcomes

  1. to correlate number of cell and functionality of progenitor cells and injury score following everolimus eluting stent

    Time frame: baseline

    to correlate the number and cell functionality of progenitor cells following everolimus eluting stent and the injury score analyses measured by optical coherence tomography

  2. to evaluate other subtypes of cells with neointimal hyperplasia

    Time frame: 9 months

    To evaluate the role of other subtypes of cells CD 133+/KDR+, following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography

  3. to evaluate other subtypes of cells with neointimal hyperplasia

    Time frame: 9 months

    the role of other subtypes of cells CD 14+ following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography

  4. to evaluate endothelial cell markers with neointimal hyperplasia

    Time frame: 9 months

    the role of endothelial cell markers (VE cadherin, P1H12) following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography

  5. to evaluate integrin expression of MAC-1 (Macrophage-1 antigen) with neointimal hyperplasia

    Time frame: 9 months

    the role of integrin expression of MAC-1(Macrophage-1 antigen) following an everolimus eluting stent implantation with the grade of neointimal hyperplasia measured by optical coherence Tomography

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation and the Development of Neointimal Hyperplasia and Stent Restenosis (REVER Trial).

Acronym: REVER

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Jul 12, 2017
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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