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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000035684
Enrollment
60
Registered
2019-01-28
Start date
2018-12-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

None listed

Sponsors

Department of Cardiology, Nishinomiya Municipal Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: i) Patients aged 20 years or older at the time of informed consent; ii) Cases of significant stenotic lesions in the coronary artery with a vessel diameter of 2.5 mm to 3.5 mm, which are visually confirmed by coronary angiography; iii) Cases where the data on coronary angiography and IVUS before and after stent placement are properly recorded; and iv) With regard to the cases already underwent angioscopy at 9 +/- 3 months after stent placement, cases where the stent placement site was observed with the blood fully removed over the entire length.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Stent coverage at 9+/-3 months after stent placement as observed by angioscopy

Secondary

MeasureTime frame
- In-stent neoatherosclerosis and in-stent thrombosis at 9+/-3 months after stent placement as observed by angioscopy - Follow-up catheterization findings at 9 +/- 3 months after stent placement as observed by angioscopy - In-stent neoatherosclerosis, stent coverage and in-stent thrombosis at 3 +/- 1 months after stent placement as observed by angioscopy - Follow-up catheterization findings at 3 +/- 1 months after stent placement as observed by angioscopy - Other exploratory analyses by means of the data acquired through this study including clinical phenomena

Countries

Japan

Contacts

Public ContactKeita Okayama

Osaka University Graduate School of Medicine Department of Cardiovascular Medicine

okayama@cardiology.med.osaka-u.ac.jp06-6879-3638

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026