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Sponsor study identifier
observational
90
1 country
1
Study Start
February 1, 2015
Actual (reported)Primary Completion
January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Based on the large population of patients, in-stent restenosis (ISR) is still an important problem in the field of cardiovascular disease. How to reduce the incidence of ISR and the treatment of ISR has become the focus and hot spot. The 2018 ESC Guidelines for Cardiovascular Intervention recommends treatment of ISR under the guidance of intravascular ultrasound (IVUS), or optical coherent tomography (OCT). Circulation published a new Waksman ISR classification based on mechanisms and components of the restenosis tissue, which provides guidance for treatment strategy. Because of its good resolution, OCT makes it more accurate to distinguish the components of vascular tissue, thus providing a decision-making basis for interventional therapy. OCT examination can obtain the characteristics of the ISR more precisely. Neoatherosclerosis (NA), is one of the ISR types and accounts for more stent failure and target lesion failure than other types. Identification NA is important for decision-making of interventional therapy. However, the acquisition and analysis of OCT images not only need the digital angiography machine (DSA) equipped with the majority of hospitals, but also need professional OCT imaging equipment and technicians. Patients with severely CKD cannot bear OCT examination because of the large amount of contrast agent. OCT catheter is more than ten times the price of the CAG catheter. Therefore, identification of NA by the use of artificial intelligence (AI) is of significance to set therapeutic strategy for ISR patients, especially in patients with CKD. Our study retrospectively analyzed CAG images and OCT images of ISR patients obtained from Jan 1st,2015 to Oct 31st,2020. Identify NA by analyzing OCT images, build up U-net and V-net to analyze the CAG and OCT images, and finally build up an identification system of NA based on CAG images by AI. This study has been approved by Ethics Committee of Chinese PLA General Hospital (S2018-033-01)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2015
Actual (reported)December 21, 2019
Actual (reported)January 7, 2020
Actual (reported)January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The identification of NA
a neointima containing a diffuse border and a signal-poor region, with the struts underneath invisible because of the marked signal attenuation
through the study completion, an average of 3 years
neovascularizaion
diameter 50-300um, cavity in the stent area, not connected with the vasular
through the study completion, an average of 3 years
ISR segment in the CAG images
the segement in the stent area or within 5mm beside the stent,diameter stenosis rate\>50%
through the study completion, an average of 3 years
Images of CAG and OCT patients obtained from ISR patients were retrospectively collected and analyzed.
Our stusy analysed the images obtained from ISR patients, no extra intervention was given based on this study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
100 patients were enrolled
The General Hospital of PLA
Beijing, 100853, China
Yundai Chen, M.D
Chinese PLA General Hospital
First Submitted
December 21, 2019
First Posted
January 7, 2020
Study Start
February 1, 2015
Actual (reported)Primary Completion
January 31, 2021
Estimated (date passed)lipid-core arc
To quantify the circumferential extent of NA, the lipid-core arc was measured at a 0.2-mm interval throughout the segments showing NA.
through the study completion, an average of 3 years
Thin-cap fibroatheroma-like neointima
defined as a neointima characterized by a fibrous cap thickness at the thinnest part of \<65 μm and an angle of lipid-laden neointima of \>180 degrees
through the study completion, an average of 3 years
macrophage arc
measured at 0.2-mm intervals and divided into 5 groups: grade 0, no macrophages; grade 1, localized macrophage accumulation, \<30 degrees; grade 2, clustered accumulation, ≥30 and \<90 degrees; grade 3, clustered accumulation, ≥90 and \<270 degrees; and grade 4, clustered accumulation, ≥270 degrees.
through the study completion, an average of 3 years
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 15, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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