Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)

Primary objective is to evaluate the safety and effectiveness of the Agent ™ Paclitaxel-Coated PTCA Balloon Catheter for the treatment of Japanese subjects with a small vessel de novo native atherosclerotic coronary artery lesion or in-stent restenosis (ISR) of a previously treated lesion.

Primary endpoint: Target Lesion Failure (TLF) rate at 6 months post index-procedure. TLF is defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

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.

• ≥90% diameter stenosis.
• Stenosis that is considered a cause of stable effort angina (Only when it's without confirmation of significant stenosis).
• Stenosis that is confirmed a cause of functional ischemia with any test.
• 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.

• Target lesion length must measure (by visual estimate) ≤28 mm.
• Target lesion must be a visually estimated reference vessel diameter (RVD) ≥2.00mm and <3.00 mm (This applys for SV trial. For ISR substudy: RVD ≥2.00mm and ≤4.00 mm.).
• Target lesion must be a de novo lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100% (This applys for SV trial. For ISR substudy: Target lesion for ISR must be in-stent restenosis of a previously-treated lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100%.).
• Coronary anatomy is likely to allow delivery of an investigational device to the lesions.
• Target lesion must be successfully pre-dilated.
• Planned treatment of 2 coronary artery lesions in 2 vessels may be treated (For SV trial, up to two lesions per vessel can be treated. For ISR substudy, single lesion per vessel can be treated.).

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.
• Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure.
• Subject has renal failure with a serum creatinine of > 2.0mg/dL or who is receiving dialysis or chronic immunosuppressant therapy.
• Subjects has one of the following.

• Not expected to live for the duration of the study (1 year) by investigator's discretion due to other serious medical illness.
• Current problems with substance abuse.
• Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
• Planned PCI (including staged procedures) or CABG after the index procedure.
• Subject previously treated at any time with intravascular brachytherapy.
• Subject has a known allergy to contrast and/or the investigational device or protocol-required concomitant medications, iopromide, raw materials of Agent DCB and SeQuent Please DCB, P2Y12 inhibitor or aspirin).
• Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
• Subject has a white blood cell (WBC) count < 3,000 cells/mm3.
• Subject has documented or suspected liver disease, including laboratory evidence of hepatitis.
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
• Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
• Target vessel has been treated with Paclitaxel Eluting Stent or Balloon prior to the index procedure.
• Target vessel has been treated with any type of PCI within 6 months prior to the index procedure.
• Target vessel requires the use of adjunctive primary treatment modalities immediately prior to investigational device's treatment.
• Non-target vessel has been treated with any type of PCI within 24 hours prior to the index procedure.
• Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint.
• Subject intends to participate in another investigational drug or device clinical trial within 6 months after the index procedure.
• Subject with known intention to procreate within 6 months after the index procedure.
• Subject is a woman who is pregnant or nursing.
• Target lesion meets any of the following criteria:

• Left main location.
• Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate.
• > 50% stenosis of an additional lesion proximal or distal to the target lesion (by visual estimate).
• Located within a saphenous vein graft or an arterial graft.
• Will be accessed via a saphenous vein graft or an arterial graft.
• Involves a complex bifurcation (e.g., bifurcations requiring treatment with more than 1 stent).
• TIMI flow 0 (total occlusion) prior to wire crossing.
• Excessive tortuosity proximal to or within the lesion.
• Extreme angulation proximal to or within the lesion.
• Target lesion and/or target vessel proximal to the lesion is severely calcified by visual estimate to expect sub-optimal balloon expansion.
• Target lesion and/or target vessel adjacent to the target lesion presents with dissection or aneurysm by visual estimate.
• Restenosis from previous intervention (This is applicable only to SV trial.).
• PCI within 10 mm proximal or distal to the target lesion (by visual estimate) at any time prior to the index procedure （This is applicable only to SV trial.）.
• Planned treatment of a single lesion with more than 1 investigational device.
• In-stent restenosis due to stent fracture or recoil (This is applicable only to ISR substudy.).
• Non-target lesion to be treated during the index procedure meets any of the following criteria:

• Located in the target vessel (This is applicable only to ISR substudy.).
• Located within a bypass graft (venous or arterial).
• Left main location.
• Chronic total occlusion.
• Involves a complex bifurcation.
• Located within 15 mm of the proximal or distal shoulder of the target lesion by visual estimate in the case of the same vessel with a target lesion for SV trial.
• Subject has unprotected left main coronary artery disease (>50% diameter stenosis).
• Thrombus, or possible thrombus, present in the target vessel.
• Subject with known coronary artery spasm.