P030 clinical trial
- Conditions
- Ischemic heart disease
- Registration Number
- JPRN-jRCT2080224719
- Lead Sponsor
- IPRO CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 312
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method