Coronary Artery Disease
Conditions
Interventions
None listed
Sponsors
Department of Internal Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated; 2) Patients aged 20 to less than 85 years at the time of informed consent 3) Patients who have provided informed consent written by themselves 4) Patients who are able to undergo OFDI examinations of the site of stent placement at 1 or 3 months and at 12 months
Exclusion criteria
Exclusion criteria: 1) If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.) 2) Patients with acute myocardial infarction (AMI) 3) Patients in a state of shock 4) Patients with cardiac failure 5) Patients having a culprit lesion in the left main coronary artery trunk 6) Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate 7) Patients having an in-stent restenosis lesion as the culprit lesion 8) Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit 9) Patients on hemodialysis 10) Cancer patients with a life expectancy of less than 2 years 11) Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months 12) Pregnant women or women expected to become pregnant 13) Patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of stent-strut coverage determined by OFDI at 3 months after stent placement (To observe temporal course from the early stage, the rate of stent-strut coverage in the 1-month arm will also be evaluated in a complementary manner, separately from the 3-month arm.) | — |
Countries
Japan
Contacts
Public ContactKanako Omiya
The Academic Research Group for Exploring Undiscovered Mechanisms of Cardiovascular Diseases Department of cardiovascular medicine
Outcome results
None listed