Neointimal Features in Patients With Restenosis of Calcified Lesions
NCT ID: NCT05451368
Last Updated: 2022-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2022-03-17
2023-03-31
Brief Summary
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Detailed Description
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Firstly, the presence of calcification makes the neointima heal slowly. In addition DES has an anti-proliferative effect, which further diminishes the healing ability of the neointima of calcified lesions and impairs the barrier function of the endothelium. This may have a similar pathway to the formation of neointimal atherosclerosis or heterogeneous endothelium within the neointima.
Secondly, stents with calcified lesions can be accompanied by incomplete stent expansion, stent fracture and stent misalignment. These conditions may accelerate the occurrence of restenosis within the stent.
Thirdly, there are different types of calcified lesions. Different types of calcified lesions may heal and restenosis in different ways.
It is therefore understood that calcified lesion healing has a number of pathways that exist in contradiction. These are issues that need to be explored in depth.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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calcified group
A calcified coronary culprit lesion was defined as "readily apparent densities noted within the apparent vascular wall at the site of the stenosis". target lesions were classified as severe ("radio opacities noted without cardiac motion prior to contrast injection generally involving both sides of the arterial wall"),moderate ("densities noted only during the cardiac cycle prior to contrast injection").Severe and moderate calcification is classified as a calcified group.
Coronary artery calcification lesions
Calcification of atherosclerosis, a complex, organic, regulated and active process, is one of the manifestations of atherosclerosis. The progression of coronary atherosclerosis is a strong independent predictor of future coronary events. It has been shown that coronary artery calcification affects the healing of the neointima and the function of the endothelium after stenting. This may lead to changes in neointimal morphology and the development of neoatherosclerosis after stent implantation.
non-calcified group
none/mild(lesions other than severe and moderate calcified lesions). none/mild calcification is classified as a non-calcified group.
No interventions assigned to this group
Interventions
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Coronary artery calcification lesions
Calcification of atherosclerosis, a complex, organic, regulated and active process, is one of the manifestations of atherosclerosis. The progression of coronary atherosclerosis is a strong independent predictor of future coronary events. It has been shown that coronary artery calcification affects the healing of the neointima and the function of the endothelium after stenting. This may lead to changes in neointimal morphology and the development of neoatherosclerosis after stent implantation.
Eligibility Criteria
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Inclusion Criteria
2. The patient had undergone coronary angiography at our hospital for PCI and had first ISR with drug-eluting stent implantation.
3. Calcified lesion greater than 5 mm in length.
4. Stent implantation time greater than 30 days.
Exclusion Criteria
2. Planned modification of the DAPT regimen for medical reasons or other surgical procedures requiring modification within 3 months of the index procedure.
3. Patients undergoing heart transplantation.
4. Significant angiogenic lesions in the target vessel that may prevent stent delivery and deployment.
5. Bifurcation disease lesions involving collateral branches ≥ 2.5 mm in diameter.
6. Lesions deemed by the investigator to be unsuitable for OCT imaging (e.g., extremely curved, very distal lesions).
7. Serum creatinine \> 2.0 mg/dl at the time of treatment.
8. Greater than three types of stent implantation.
9. Subjects with malignancy or other co-morbidities (i.e., severe liver, kidney, lung, or pancreatic disease with a life expectancy of less than 18 months or which may result in protocol non-compliance).
18 Years
ALL
No
Sponsors
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Shenyang Northern Hospital
OTHER
Responsible Party
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Zhen Fang
clinical doctor
Principal Investigators
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geng wang, M.D.
Role: STUDY_CHAIR
The General Hospital of Northern Theater Command
Locations
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ShenyangNH
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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plz333333
Identifier Type: -
Identifier Source: org_study_id
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