Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV) (NCT04058990) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
Japan180 participantsStarted 2019-12-12
Plain-language summary
A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject must be at least 20 years of age.
✓. Subject understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
✓. Subject is eligible for percutaneous coronary intervention (PCI).
✓. Subject has documented stable angina pectoris or unstable angina pectoris. If subject has documented stable angina pectoris, one of the following criteria meet.
✓. Subject is an acceptable candidate for coronary artery bypass grafting (CABG).
✓. Subject is willing to comply with all protocol-required follow-up evaluation.
✓. Patients undergoing first or second treatment for ISR lesions for the non-randomized ISR substudy.
✓. The target lesion meets all following criteria.
Exclusion criteria
✕. Subject has had an acute myocardial infarction within 72 hours prior to the index procedure.
✕. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina.
✕. Subject has severe left ventricular dysfunction with ejection fraction \<30%.
✕. Subject has received an organ transplant or is on a waiting list for an organ transplant.
What they're measuring
1
Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)