AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population

Not Applicable

Completed

Conditions: Myocardial Ischemia
Coronary Artery Disease

Interventions: Device: Absorb™ BVS
Device: XIENCE PRIME®/XIENCE Xpedition™

Registration Number: NCT01844284

Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description: Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 400

Inclusion Criteria

Subject must be at least 20 years of age.
Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
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.
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.

* Except for non-pregnancy is apparent, negative pregnancy result within 7 days prior to the index procedure is required.
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.
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

Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
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.
Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure
- The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes
- Creatine Kinase (CK) and Creatine Kinase - Muscle and Brain (CK-MB) have not returned to within normal limits at the time of index procedure.
Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
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).
The target vessel was treated by PCI within 12 months.
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.
Subject requires future staged PCI either in target or non target vessels.
Subject has a malignancy that is not in remission.
Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.,). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease.
Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin or any other agent for any reason).
Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
Subject has a documented or suspected cirrhosis of Child-Pugh ≥ Class B.
Subject has known renal insufficiency;
- Dialysis at the time of screening.
- An estimated Glomerular filtration rate (GFR) < 30 ml/min/1.73m2
Subject is high risk of bleeding, or difficult to have appropriate treatment;
- Has a history of bleeding diathesis or coagulopathy
- Has had a significant gastro-intestinal or significant urinary bleed within the past six months
- Has prior intracranial bleed
- Has prior intracranial bleed (including severe permanent neurologic deficit that seem to be caused by previous intracranial bleeding)
- Has known intracranial pathology that may cause intracranial bleeding per an investigator assessment (e.g. untreated aneurysm > 5 mm, arteriovenous malformation)
- Subject will refuse blood transfusions
Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
Subject has life expectancy < 3 year.
Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g. subordinate hospital staff or sponsor staff) or subject is unable to read or write.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorb™ BVS	Absorb™ BVS	Subjects receiving Absorb™ BVS
XIENCE PRIME®/XIENCE Xpedition™	XIENCE PRIME®/XIENCE Xpedition™	Subjects receiving XIENCE PRIME®/XIENCE Xpedition™

Primary Outcome Measures

Name	Time	Method
Number of Participants With Target Lesion Failure (TLF)	1 year	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Any Death/Any MI/Revascularization (DMR)	5 years	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Number of Participants With Target Vessel Failure (TVF)	5 years	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants With Target Lesion Failure (TLF)	5 years	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Cardiac Death/All MI	5 years	Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Number of Participants With All Target Vessel Revascularization (TVR)	5 years	Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With Ischemia-driven TVR (ID-TVR)	5 years	Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With All Target Lesion Revascularization (TLR)	5 years	Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Number of Participants With Ischemia-driven Revascularization (ID-TLR)	5 years	A revascularization is considered ischemia-driven if associated with any of the following: * Positive functional ischemia study including positive FFR * Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA * Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Number of Participants With Target Vessel MI (TV-MI)	5 years
Number of Participants With Stent/Scaffold Thrombosis	Very Late (1461 - 1825 days)	ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: * Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation * Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation * Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation * Very late scaffold/stent thrombosis: \>1 year post stent implantation
In-segment Late Loss (Non-inferiority)	13 months
Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG)	2 years	Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.
Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation	2 years	Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure. Absolute Vaso dilatation = Post Nitroglycerin (NTG) - Pre Nitroglycerin (NTG)
Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG)	2 years	Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.
Number of Participants With Cardiac Death, All MI, ID-TLR (MACE)	5 years
Number of Participants With Not Ischemia-driven TLR (NID-TLR)	5 years
Number of Participants With Non-Target Vessel MI (NTV-MI)	5 years
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)	5 years	Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))	5 years	- Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

Trial Locations

Locations (39): Fujita Health University
🇯🇵
Toyoake-shi, Aichi, Japan
Dokkyo University
🇯🇵
Tochigi, Utsunomiya, Japan
ShinTokyo
🇯🇵
Matsudo-shi, Chiba, Japan
Kokura Memorial Hospital
🇯🇵
Kitakyushu-shi, Fukuoka, Japan
Saiseikai Yokohamashi Tobu Hospital
🇯🇵
Yokohama-shi, Kanagawa, Japan
Kurume University
🇯🇵
Kurume-shi, Fukuoka, Japan
Hanaoka Seishu Memorial Cardiovascular Clinic
🇯🇵
Sapporo-shi, Hokkaido, Japan
Tokai University
🇯🇵
Isehara-shi, Kanagawa, Japan
Shonankamakura General Hospital
🇯🇵
Kamakura-shi, Kanagawa, Japan
Shinkoga Hospital
🇯🇵
Kurume-shi, Fukuoka, Japan
Kyoto University
🇯🇵
Kyoto, Honshu, Japan
Saitama Medical Center Jichi Medical University
🇯🇵
Saitama-shi, Saitama, Japan
Juntendo University
🇯🇵
Bunkyo-ku, Tokyo, Japan
Iwate Medical University
🇯🇵
Morioka-shi, Iwate, Japan
Saiseikai Kumamoto Hospital
🇯🇵
Kumamoto-shi, Kumamoto, Japan
Sakurabashi Watanabe Hospital
🇯🇵
Osaka-shi, Osaka, Japan
Teikyo University
🇯🇵
Itabashi-Ku, Tokyo, Japan
Showa University Hospital
🇯🇵
Shinagawa-ku, Tokyo, Japan
Yamaguchi University
🇯🇵
Ube-shi, Yamaguchi, Japan
Abbott Vascular Japan Co., Ltd.
🇯🇵
Tokyo, Japan
Nagoya Daini Red Cross Hospital
🇯🇵
Nagoya-shi, Aichi, Japan
Kobe University
🇯🇵
Kobe-shi, Hyogo, Japan
Miyazak Medical Association Hospital
🇯🇵
Miyazaki-shi, Miyazaki, Japan
Kanto Rosai Hospital
🇯🇵
Kawasaki-shi, Kanagawa, Japan
Tenri Hospital
🇯🇵
Tenri-shi, Nara, Japan
The National Cerebral and Cardiovascular Center
🇯🇵
Suita-shi, Osaka, Japan
Kurashiki Central Hospital
🇯🇵
Kurashiki-shi, Okayama, Japan
Saitama Sekishinkai
🇯🇵
Sayama-shi, Saitama, Japan
University of Tokyo
🇯🇵
Bunkyo-ku, Tokyo, Japan
Toho University Ohashi Medical Center
🇯🇵
Meguro-ku, Tokyo, Japan
Tokyo Women's Medical University
🇯🇵
Shinjuku-ku, Tokyo, Japan
Kansairosai Hospital
🇯🇵
Amagasaki-shi, Hyogo, Japan
Tsukuba Medical Center
🇯🇵
Tsukuba-shi, Ibaraki, Japan
Osaka University
🇯🇵
Suita-shi, Osaka, Japan
The Cardiovascular Institute Hospital
🇯🇵
Minato-Ku, Tokyo, Japan
Sakakibara Memorial Hospital
🇯🇵
Fuchu-shi, Tokyo, Japan
Mitsui Memorial Museum
🇯🇵
Chiyoda-ku, Tokyo, Japan
Wakayama Medical University Hospital
🇯🇵
Kimiidera, Wakayama, Japan
Tokushima Red Cross Hospital
🇯🇵
Tokushima, Japan