JPRN-jRCT2080224719CompletedPhase 3
Multicenter trial of new coronary artery stenosis with Paclitaxel coated balloon catheter
IPRO CORPORATIO0 sites312 target enrollmentStarted: June 10, 2019Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 312
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
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
- •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
Investigators
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