Multicenter trial of new coronary artery stenosis with Paclitaxel coated balloon catheter
NP030 clinical trial
NIPRO CORPORATION
+81-77-564-9467
NIPRO CORPORATION
+81-77-564-9467
completed
July. 29, 2019
312
Interventional
Multicenter, Single-arm study
treatment purpose
3
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
20age old over
No limit
Both
Ischemic heart disease
investigational material(s)
Generic name etc : Paclitaxel coated balloon catheter
INN of investigational material :
Therapeutic category code :
Dosage and Administration for Investigational material : NP030 is expanded at the target lesion by standard PTCA.
control material(s)
Generic name etc : -
INN of investigational material :
Therapeutic category code :
Dosage and Administration for Investigational material : -
safety
efficacy
confirmatory
TLF incidence rate for 9 months after the trial procedure
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
NIPRO CORPORATION
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The institutional review board at Sakurabashi Watanabe Hospital
