AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population (NCT01844284) | Clinical Trial Compass
CompletedNot Applicable
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Japan400 participantsStarted 2013-04
Plain-language summary
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
âś“. Subject must be at least 20 years of age.
âś“. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
âś“. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
âś“. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
âś“. Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
âś“. Female subject of childbearing potential must not be pregnant\* at the index procedure and does not plan pregnancy for up to 1 year following the index procedure.
âś“. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
âś“. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure
Exclusion criteria
âś•. Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
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What they're measuring
1
Number of Participants With Target Lesion Failure (TLF)
. Subject has known hypersensitivity or contraindication to device material and its degredants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
âś•. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
âś•. Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure
âś•. Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
âś•. Subject has a known left ventricular ejection fraction (LVEF) \< 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary).
âś•. The target vessel was treated by PCI within 12 months.
âś•. Prior PCI within the non-target vessel is acceptable if performed anytime \> 30 days before the index procedure or between 24 hours and 30 days before the index procedure if successful and uncomplicated.