Ischemic heart disease
Conditions
Interventions
investigational material(s)
Generic name etc : Paclitaxel coated balloon catheter
INN of investigational material :
Therapeutic category code :
Dosage and Administration for Investigational material
Sponsors
NIPRO CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical inclusion criteria - Patient with stable or unstable angina pectoris or documented silent ischemia - Patient is eligible for percutaneous coronary intervention - Patient is acceptable candidate for CABG Angiographic inclusion criteria (by visual estimation) - Native coronary artery - The lesions in the main coronary artery or in a branch of it - De novo lesion - Stenotic lesion - The stenosis of target lesion is 50% or more to less than 100% - Target vessel diameter is 3.00 mm to 4.25 mm - Lesion length is 32 mm or less
Exclusion criteria
Exclusion criteria: Clinical exclusion criteria - Patients who have serious illness and may not be able to follow up as defined in the protocol - Patients who have a history of allergy or contraindications to Paclitaxel and the raw materials for clinical trial equipment (polyamide and Iopromide) - Not a suitable candidate for DAPT - Known allergy to contrast media - Low cardiac function or suspected, LVEF less than 30% - Patients with hepatitis or cirrhosis or their suspicion - Renal dialysis or with renal dysfunction (Cre > 2.0 mg / dL) - Patients with active peptic ulcer or gastrointestinal bleeding - Patients with a history of coronary artery spasm - Cerebral infarction or transient ischemic attack within 3 months before the clinical trial procedure - AMI within 72 hours before the clinical trial procedure - PCI within 24 hours before the clinical trial procedure - Patients who are planning to PCI or CABG within 3 months after the clinical trial procedure - Patients scheduled for invasive or surgical procedure that must be discontinued for DAPT drugs in 3 months after the clinical trial procedure - Pregnant or may be pregnant - Currently participating in an investigational drug or device study - In cases where the Investigator determines that the patient's participation in the trial is inappropriate Angiographic exclusion criteria - Within 9 months after implementing PCI on the target vessel -A vessel where there is an untreated intravascular thrombus - Treat with a high-speed rotational coronary atherectomy device, laser catheter for angioplasty, absorbable coronary stents, or devices that are not approved for use during a clinical trial procedure. - Lesion in left main coronary trunk - Lesion within 3 mm from the ostium right coronary artery - Lesion within 2 mm from the ostium left anterior descending/the ostium left circumflex branch - A lesion that needs to be treated using a PTCA balloon catheter with a special function in the balloon before using the trial device - Total occlusion - A lesion in which a stent has been placed within 5 mm proximal or distal in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy confirmatory TLF incidence rate for 9 months after the trial procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy confirmatory Efficacy - Device success rate - Procedure success rate - Residual stenosis(in segment) - Acute gain(in segment) - %diameter stenosis at 11 months(in segment) - Late lumen loss at 11months(in segment) - Late Lumen Enlargement at 11 months(in segment) - Incidence rate from restenosis at 11months(in segment) - Incidence rate from TLR at 9months Safety (in hospital, 30 days, 6 months, 9 months, 12 months, 2 years, 3 years, 4 years and 5 years) - TLR, TLF, TVR, TVF - Target vessel-induced myocardial infarction(QMI, NQMI) - Myocardial Infarction (QMI, NQMI) - Cardiac death - Cardiac death, non-cardiac death - Cardiac death, Myocardial Infarction (QMI, NQMI) - Thrombosis (per Academic Research Consortium [ARC] definition) Incidence rate of adverse events that can't be denied for causality with clinical trial equipment from hospitalization to 9 months after clinical trial procedure | — |
Countries
Japan
Outcome results
None listed