Patients with De Novo SV lesions or ISR lesions
Conditions
Interventions
PCI
PCI,DCB
Sponsors
Nakamura Masato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 20 years or older. Patients who understand the requirements and procedures of the present clinical trial and have provided written informed consent prior to undergoing any study specific examinations or procedures. Patients who are indicated for PCI. Patients diagnosed with either stable angina or unstable angina. In the case of stable angina, patients must meet at least one of the following criteria 1. A stenotic lesion with over 90 percent diameter narrowing. 2. A stenotic lesion considered to be the cause of stable effort angina, provided that no other significant stenotic lesions are present. 3. A stenotic lesion confirmed to be the cause of ischemia based on functional ischemia assessment. Patients who may be eligible for CABG. Note, In addition, angiographic inclusion criteria are also defined.
Exclusion criteria
Exclusion criteria: Patients who have experienced an acute myocardial infarction within 72 hours prior to the study procedure. Patients with cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical circulatory assistance, refractory ventricular arrhythmias, or ongoing refractory angina. Patients with severe left ventricular dysfunction, defined as a left ventricular ejection fraction of less than 30 percent. Patients with a history of organ transplantation or those scheduled to undergo organ transplantation. Patients who have received or are scheduled to receive cancer chemotherapy within 30 days before or after the study procedure. Patients with renal failure, defined as a serum creatinine level exceeding 2.0 mg per dL, or those undergoing dialysis or chronic immunosuppressive therapy. Note, in addition, angiographic exclusion criteria are also defined.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of TLF at 6 months after the index procedure | — |
Countries
Japan, non
Contacts
Public ContactKumiko Sato
Clinical Operation
Outcome results
None listed