Evaluation of Neo-intimal Coverage after Coronary Stent Implantation by High-Resolution Angioscopic Catheter

Not Applicable

• Conditions: Coronary artery disease

• Registration Number: JPRN-UMIN000035684
• Lead Sponsor: Department of Cardiology, Nishinomiya Municipal Central Hospital

Brief Summary

A strong relationship was observed between NIC grade and in-stent thrombus in all stents (p=0.0011), and between the heterogeneity value and stent thrombus (p=0.012). There was no statistical difference in NIC grade between BP CoPt-EES vs. DP CoCr-EES(p=0.17) and neither in the heterogeneity value of neointima (p=0.49). The ratio of stent thrombus did not reach statistical difference(p=0.23).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-28
• Study Completion: 2020-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

i) Cases where the treatment site to be observed is completely obstructed, highly calcified or in the left main trunk; ii) Cases with another stent placed within 10 mm of the stent placement site subject to observation; iii) Patients with cardiogenic shock or significantly decreased cardiac function (EF: 30% or less); iv) Patients undergoing maintenance dialysis; v) Patients who are participating or planning to participate in other clinical trials or in clinical studies that require intervention before this study's follow-up catheterization at 9 +/- 3 months after stent placement finishes; vi) With regard to the cases before follow-up catheterization at 9 +/- 3 months after stent placement, cases in which follow-up catheterization at 9 +/- 3 months seems to be difficult to undergo.; and vii) Patients who are pregnant or breast-feeding.

Study & Design

• Study Type: Observational
• Study Design: Not specified