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

NCT01844284 | Completed Results DMC

• 1 other identifier: 12-301
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 39

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Keywords

Absorb™ BVS; Angioplasty; Bioabsorbable; Bioreabsorbable; BVS; Coronary Artery Disease; Coronary Artery Endothelial Responsiveness; Coronary artery restenosis; Coronary artery stenosis; Coronary scaffold; Coronary Stent; Drug eluting stents; Everolimus; Myocardial ischemia; Stent thrombosis; Stents

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Target Lesion Failure (TLF)

  Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  1 year

Secondary Outcomes (101)

• Number of Participants With Any Death/Any MI/Revascularization (DMR)

  ≤ 7 days post index procedure (In-hospital )

• Number of Participants With Any Death/Any MI/Revascularization (DMR)

  1 month

• Number of Participants With Any Death/Any MI/Revascularization (DMR)

  6 months

• Number of Participants With Any Death/Any MI/Revascularization (DMR)

  1 year

• Number of Participants With Any Death/Any MI/Revascularization (DMR)

  2 years

Study Arms (2)

Absorb™ BVS

EXPERIMENTAL

Subjects receiving Absorb™ BVS

Device: Absorb™ BVS

XIENCE PRIME®/XIENCE Xpedition™

ACTIVE COMPARATOR

Subjects receiving XIENCE PRIME®/XIENCE Xpedition™

Device: XIENCE PRIME®/XIENCE Xpedition™

Interventions

XIENCE PRIME®/XIENCE Xpedition™ DEVICE

Subjects receiving XIENCE PRIME®/XIENCE Xpedition™

XIENCE PRIME®/XIENCE Xpedition™

Absorb™ BVS DEVICE

Subjects receiving Absorb™ BVS

Absorb™ BVS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (39)

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

Fujita Health University

Toyoake-shi, Aichi-ken, 470-1192, Japan

Location

ShinTokyo

Matsudo-shi, Chiba, 270-2232, Japan

Location

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, 802-8555, Japan

Location

Kurume University

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Shinkoga Hospital

Kurume-shi, Fukuoka, 830-8577, Japan

Location

Hanaoka Seishu Memorial Cardiovascular Clinic

Sapporo, Hokkaido, 062-0003, Japan

Location

Kyoto University

Kyoto, Honshu, 606-8507, Japan

Location

Kansairosai Hospital

Amagasaki-shi, Hyōgo, 660-8511, Japan

Location

Kobe University

Kobe, Hyōgo, 650-0017, Japan

Location

Tsukuba Medical Center

Tsukuba, Ibaraki, 305-8558, Japan

Location

Iwate Medical University

Morioka, Iwate, 020-8505, Japan

Location

Tokai University

Isehara-shi, Kanagawa, 259-1193, Japan

Location

Shonankamakura General Hospital

Kamakura-shi, Kanagawa, 247-8533, Japan

Location

Kanto Rosai Hospital

Kawasaki-shi, Kanagawa, 211-8510, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, 230-8765, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, 861-4193, Japan

Location

Miyazak Medical Association Hospital

Miyazaki, Miyazaki, 880-0834, Japan

Location

Tenri Hospital

Tenri-shi, Nara, 632-8552, Japan

Location

Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken, 710-8602, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, Osaka, 530-0001, Japan

Location

Osaka University

Suita-shi, Osaka, 565-0871, Japan

Location

The National Cerebral and Cardiovascular Center

Suita-shi, Osaka, 565-8565, Japan

Location

Saitama Medical Center Jichi Medical University

Saitama-shi, Saitama, 330-8503, Japan

Location

Saitama Sekishinkai

Sayama-shi, Saitama, 350-1323, Japan

Location

Juntendo University

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

University of Tokyo

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Mitsui Memorial Museum

Chiyoda-ku, Tokyo, 101-8643, Japan

Location

Sakakibara Memorial Hospital

Fuchu-shi, Tokyo, 183-0003, Japan

Location

Teikyo University

Itabashi-Ku, Tokyo, 173-8606, Japan

Location

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, 153-8515, Japan

Location

The Cardiovascular Institute Hospital

Minato-Ku, Tokyo, 106-0031, Japan

Location

Showa University Hospital

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Tokyo Women's Medical University

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Dokkyo University

Tochigi, Utsunomiya, 321-0293, Japan

Location

Wakayama Medical University Hospital

Kimiidera, Wakayama, 641-8509, Japan

Location

Yamaguchi University

Ube-shi, Yamaguchi, 755-8505, Japan

Location

Tokushima Red Cross Hospital

Tokushima, 773-8502, Japan

Location

Abbott Vascular Japan Co., Ltd.

Tokyo, 108-6304, Japan

Location

Related Publications (8)

• 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.

  PMID: 33893022 DERIVED

• 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.

  PMID: 32213737 DERIVED

• 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.

  PMID: 31918929 DERIVED

• 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.

  PMID: 31561250 DERIVED

• 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.

  PMID: 29622143 DERIVED

• 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.

  PMID: 29089314 DERIVED

• 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.

  PMID: 26825231 DERIVED

• 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.

  PMID: 26330419 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Coronary Restenosis; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Hajime Kusano
• Organization: Abbott Vascular

hajime.kusano@av.abbott.com

408-845-1626

Study Officials

• Takeshi Kimura, MD

  Kyoto University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 16, 2019
• Last Updated: October 8, 2020
• Results First Posted: February 6, 2019

Record last verified: 2019-07

Locations

JP (39)