- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03214900
Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation (REVER)
Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation and the Development of Neointimal Hyperplasia and Stent Restenosis (REVER Trial).
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline
|
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
|
9 months
|
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
|
9 months
|
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
|
9 months
|
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
|
9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI11/00299
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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