Coronary artery disease
Conditions
Interventions
None listed
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Stent coverage at 9+/-3 months after stent placement as observed by angioscopy | — |
Secondary
| Measure | Time 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
Osaka University Graduate School of Medicine Department of Cardiovascular Medicine