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

NCT ID: NCT01844284

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2019-01-16

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Absorb™ BVS

Subjects receiving Absorb™ BVS

Group Type: EXPERIMENTAL

Absorb™ BVS

Intervention Type: DEVICE

Subjects receiving Absorb™ BVS

XIENCE PRIME®/XIENCE Xpedition™

Subjects receiving XIENCE PRIME®/XIENCE Xpedition™

Group Type: ACTIVE_COMPARATOR

XIENCE PRIME®/XIENCE Xpedition™

Intervention Type: DEVICE

Subjects receiving XIENCE PRIME®/XIENCE Xpedition™

Interventions

XIENCE PRIME®/XIENCE Xpedition™

Subjects receiving XIENCE PRIME®/XIENCE Xpedition™

Intervention Type: DEVICE

Absorb™ BVS

Subjects receiving Absorb™ BVS

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject must be at least 20 years of age.

2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.

3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).

4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

5. 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.

6. 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.

7. 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.

8. 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

1. Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.

2. 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.

3. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.

4. 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.

5. Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.

6. 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).

7. The target vessel was treated by PCI within 12 months.

8. 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.

9. Subject requires future staged PCI either in target or non target vessels.

10. Subject has a malignancy that is not in remission.

11. 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.

12. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.

13. Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.

14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin or any other agent for any reason).

15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.

16. Subject has a documented or suspected cirrhosis of Child-Pugh ≥ Class B.

17. Subject has known renal insufficiency;

• Dialysis at the time of screening.
• An estimated Glomerular filtration rate (GFR) < 30 ml/min/1.73m2

18. 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

19. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,

20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.

21. Subject has life expectancy < 3 year.

22. 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.

23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

24. 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takeshi Kimura, MD

Role: PRINCIPAL_INVESTIGATOR

Kyoto University

Locations

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, Japan

Fujita Health University

Toyoake-shi, Aichi-ken, Japan

ShinTokyo

Matsudo-shi, Chiba, Japan

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, Japan

Kurume University

Kurume-shi, Fukuoka, Japan

Shinkoga Hospital

Kurume-shi, Fukuoka, Japan

Hanaoka Seishu Memorial Cardiovascular Clinic

Sapporo, Hokkaido, Japan

Kyoto University

Kyoto, Honshu, Japan

Kansairosai Hospital

Amagasaki-shi, Hyōgo, Japan

Kobe University

Kobe, Hyōgo, Japan

Tsukuba Medical Center

Tsukuba, Ibaraki, Japan

Iwate Medical University

Morioka, Iwate, Japan

Tokai University

Isehara-shi, Kanagawa, Japan

Shonankamakura General Hospital

Kamakura-shi, Kanagawa, Japan

Kanto Rosai Hospital

Kawasaki-shi, Kanagawa, Japan

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Miyazak Medical Association Hospital

Miyazaki, Miyazaki, Japan

Tenri Hospital

Tenri-shi, Nara, Japan

Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken, Japan

Sakurabashi Watanabe Hospital

Osaka, Osaka, Japan

Osaka University

Suita-shi, Osaka, Japan

The National Cerebral and Cardiovascular Center

Suita-shi, Osaka, Japan

Saitama Medical Center Jichi Medical University

Saitama-shi, Saitama, Japan

Saitama Sekishinkai

Sayama-shi, Saitama, Japan

Juntendo University

Bunkyo-ku, Tokyo, Japan

University of Tokyo

Bunkyo-ku, Tokyo, Japan

Mitsui Memorial Museum

Chiyoda-ku, Tokyo, Japan

Sakakibara Memorial Hospital

Fuchu-shi, Tokyo, Japan

Teikyo University

Itabashi-Ku, Tokyo, Japan

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, Japan

The Cardiovascular Institute Hospital

Minato-Ku, Tokyo, Japan

Showa University Hospital

Shinagawa-ku, Tokyo, Japan

Tokyo Women's Medical University

Shinjuku-ku, Tokyo, Japan

Dokkyo University

Tochigi, Utsunomiya, Japan

Wakayama Medical University Hospital

Kimiidera, Wakayama, Japan

Yamaguchi University

Ube-shi, Yamaguchi, Japan

Tokushima Red Cross Hospital

Tokushima, , Japan

Abbott Vascular Japan Co., Ltd.

Tokyo, , Japan

Countries

Japan

References

Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.

Reference Type: DERIVED

PMID: 33893022 (View on PubMed)

Kozuma K, Tanabe K, Hamazaki Y, Okamura T, Ando J, Ikari Y, Nakagawa Y, Kusano H, Ediebah D, Kimura T; ABSORB Japan Investigators. Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent - A Randomized Comparison Through 5 Years in Japan. Circ J. 2020 Apr 24;84(5):733-741. doi: 10.1253/circj.CJ-19-1184. Epub 2020 Mar 26.

Reference Type: DERIVED

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Onuma Y, Honda Y, Asano T, Shiomi H, Kozuma K, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Hanaoka KI, Tanabe K, Okada K, Kitahara H, Ono M, Kusano H, Rapoza R, Simonton C, Popma JJ, Stone GW, Fitzgerald PJ, Serruys PW, Kimura T. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years. JACC Cardiovasc Interv. 2020 Jan 13;13(1):116-127. doi: 10.1016/j.jcin.2019.09.047.

Reference Type: DERIVED

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Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.

Reference Type: DERIVED

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Okada K, Honda Y, Kitahara H, Otagiri K, Tanaka S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Kimura T; ABSORB Japan Investigators. Bioresorbable Scaffold for Treatment of Coronary Artery Lesions: Intravascular Ultrasound Results From the ABSORB Japan Trial. JACC Cardiovasc Interv. 2018 Apr 9;11(7):648-661. doi: 10.1016/j.jcin.2017.11.034.

Reference Type: DERIVED

PMID: 29622143 (View on PubMed)

Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.

Reference Type: DERIVED

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Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.

Reference Type: DERIVED

PMID: 26825231 (View on PubMed)

Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.

Reference Type: DERIVED

PMID: 26330419 (View on PubMed)

Other Identifiers

12-301

Identifier Type: -

Identifier Source: org_study_id