Neointimal Features in Patients With Restenosis of Calcified Lesions

Characteristics of Intimal and Neoatherosclerosis in Patients With Restenosis After DES Implantation for Calcified Lesions

Previous studies have suggested that restenosis (RS) after stenting is mainly due to smooth muscle cell proliferation and migration, but recent evidence suggests that in-stent restenosis（ISR） is associated with a number of factors. Coronary artery calcification is an independent predictor of ischaemia-mediated revascularisation 1 year after percutaneous coronary intervention (PCI) following RS.The characteristics of new neointima in patients with in-stent restenosis of calcified lesions are important issues to explore

Study Overview

• Status: Recruiting
• Conditions: Restenosis; Coronary Artery Calcification; Neointima; Neoatherosclerosis
• Intervention / Treatment: Other: Coronary artery calcification lesions

Detailed Description

The characteristics of the endothelium after DES following implantation of calcified lesions have always been of interest to us. Its inherent peculiarities make the new endothelium of calcified lesions different.

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: geng wang, M.D.; Phone Number: 13309886393; Email: wanggeng69@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • ShenyangNH
      • Contact: Zhen Fang; Phone Number: 15804084542; Email: plz333333@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who had previously undergone stenting in our department were first found to have restenosis due to symptomatic admission angiography, and patients with restenosis were divided into calcified and non-calcified groups according to their first coronary angiography images by OCT.

Description

Inclusion Criteria:

1. The patient is older than 18 years.
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:

1. Bridge vessel lesions following coronary artery bypass grafting.
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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean lumen area	Quantitative Indicators，the mean area bounded by the luminal border on OCT（Optical Coherence Tomography）	through study completion, an average of 1 year
Minimum lumen area	Quantitative Indicators，the minimum area bounded by the luminal border on OCT	through study completion, an average of 1 year
Maximum lumen area	Quantitative Indicators，the maximum area bounded by the luminal border on OCT	through study completion, an average of 1 year
Percent area stenosis	Quantitative Indicators，the (reference lumen area minus the minimum lumen area) divided by the reference lumen area, multiplied by 100. The reference segment used should be specified (proximal, distal, largest or average) on OCT	through study completion, an average of 1 year
Mean stent area	Quantitative Indicators，the mean area bounded by the stent border on OCT	through study completion, an average of 1 year
Minimum stent area	Quantitative Indicators，the Minimum area bounded by the stent border on OCT	through study completion, an average of 1 year
Maximum stent area	Quantitative Indicators，the Maximum area bounded by the stent border on OCT	through study completion, an average of 1 year
lipid-laden intima	Qualitative indicators,a diffusely bordered, signal-poor region with overlying signal-rich bands in the intima on OCT.the investigators measured its incidence on OCT.	through study completion, an average of 1 year
Calcification	Qualitative indicators,shows a well-delineated, signal-poor region with sharp borders.the investigators measured its incidence on OCT.	through study completion, an average of 1 year
Thrombi	Qualitative indicators,masses protruding into the lumen and discontinuous from the surface of the vessel wall.the investigators measured its incidence on OCT.	through study completion, an average of 1 year
Intimal rupture	Qualitative indicators,discontinuity of the fibrous cap connecting the lumen.the investigators measured its incidence on OCT.	through study completion, an average of 1 year
Neovascularization	Qualitative indicators,the presence of signal-poor holes or tubular structures with a diameter of 50 to 300 μm that are not connected to the vessel lumen.the investigators measured its incidence on OCT.	through study completion, an average of 1 year
Thin-cap fibroatheroma (TCFA)	containing intima was defined as fibrous cap thickness ≤65 μm at the thinnest segment and an angle of lipid tissue ≥180°.the investigators measured its incidence on OCT.	through study completion, an average of 1 year
Macrophage infiltration	Qualitative indicators,a bright spot with a high signal variance from the surrounding tissue.the investigators measured its incidence on OCT.	through study completion, an average of 1 year
Stent underexpansion	Qualitative indicators,Stent expansion describes the minimum stent cross-sectional area either as an absolute measure (absolute expansion), or compared with the predefined reference area, which can be the proximal, distal, largest, or average reference area (relative expansion).the investigators measured its incidence on OCT.	through study completion, an average of 1 year
stent fracture	Qualitative indicators,the interruption of stent continuity.the investigators measured its incidence on OCT.	through study completion, an average of 1 year
Uncovered struts	the ratio of uncovered-to-total stent struts per section was calculated and expressed as percent on OCT.	through study completion, an average of 1 year
neoatherosclerosis	neoatherosclerosis were defined by the presence of one or more of the following: lipid laden tissue ，thin-cap fibroatheroma (TCFA)，neointimal calcification，Macrophage infiltration.the investigators measured its incidence .	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Shenyang Northern Hospital
• Investigators: Study Chair: Geng Wang, M.D., The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2022
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (ACTUAL): July 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: neoatherosclerosis; coronary artery calcification; ISR
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis; Neointima
• Other Study ID Numbers: plz333333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The provision of individual patient data requires the informed consent of the patient. In addition, basic information about the patient and coronary angiography results may be provided in the form of pictures or videos. OCT results need to be analyzed in specialized offline software, and the investigators provide the most intuitive OCT results possible.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No