Neointimal Features in Patients With Restenosis of Calcified Lesions

Last updated: July 14, 2022
Sponsor: Shenyang Northern Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scleroderma

Treatment

N/A

Clinical Study ID

NCT05451368
plz333333
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient is older than 18 years.
  2. The patient had undergone coronary angiography at our hospital for PCI and had firstISR with drug-eluting stent implantation.
  3. Calcified lesion greater than 5 mm in length.
  4. Stent implantation time greater than 30 days.

Exclusion

Exclusion Criteria:

  1. Bridge vessel lesions following coronary artery bypass grafting.
  2. Planned modification of the DAPT regimen for medical reasons or other surgicalprocedures 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 deliveryand 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., extremelycurved, 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, orpancreatic disease with a life expectancy of less than 18 months or which may resultin protocol non-compliance).

Study Design

Total Participants: 120
Study Start date:
March 17, 2022
Estimated Completion Date:
March 31, 2023

Study 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.

Connect with a study center

  • ShenyangNH

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.