JPRN-jRCT2080224719
Completed
Phase 3
Multicenter trial of new coronary artery stenosis with Paclitaxel coated balloon catheter
IPRO CORPORATIO0 sites312 target enrollmentJune 10, 2019
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IPRO CORPORATIO
- Enrollment
- 312
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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%
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
Outcomes
Primary Outcomes
Not specified
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