Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
Status
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Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Subject must be at least 20 years of age.
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Subject understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
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Subject is eligible for percutaneous coronary intervention (PCI).
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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.
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Subject is an acceptable candidate for coronary artery bypass grafting (CABG).
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Subject is willing to comply with all protocol-required follow-up evaluation.
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Patients undergoing first or second treatment for ISR lesions for the non-randomized ISR substudy.
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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.
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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
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Subject has had an acute myocardial infarction within 72 hours prior to the index procedure.
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Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina.
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Subject has severe left ventricular dysfunction with ejection fraction <30%.
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Subject has received an organ transplant or is on a waiting list for an organ transplant.
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Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure.
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Subject has renal failure with a serum creatinine of > 2.0mg/dL or who is receiving dialysis or chronic immunosuppressant therapy.
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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.
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Planned PCI (including staged procedures) or CABG after the index procedure.
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Subject previously treated at any time with intravascular brachytherapy.
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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).
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Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
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Subject has a white blood cell (WBC) count < 3,000 cells/mm3.
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Subject has documented or suspected liver disease, including laboratory evidence of hepatitis.
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Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
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Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
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Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
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Target vessel has been treated with Paclitaxel Eluting Stent or Balloon prior to the index procedure.
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Target vessel has been treated with any type of PCI within 6 months prior to the index procedure.
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Target vessel requires the use of adjunctive primary treatment modalities immediately prior to investigational device's treatment.
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Non-target vessel has been treated with any type of PCI within 24 hours prior to the index procedure.
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Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint.
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Subject intends to participate in another investigational drug or device clinical trial within 6 months after the index procedure.
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Subject with known intention to procreate within 6 months after the index procedure.
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Subject is a woman who is pregnant or nursing.
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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.).
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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.
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Subject has unprotected left main coronary artery disease (>50% diameter stenosis).
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Thrombus, or possible thrombus, present in the target vessel.
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Subject with known coronary artery spasm.
Trial design
Primary purpose
Allocation
Interventional model
Masking
180 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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