ABSORB EXTEND Clinical Investigation

NCT01023789 | Completed Results DMC

• 3 other identifiers: 09-386ACTRN12610000131055REFCTRI000460, 03-05-2010
• Study Type: interventional
• Target: 812
• Locations: 24 countries
• Sites: 52

Brief Summary

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.

Conditions

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

Keywords

Drug eluting stent; Stents; Angioplasty; Bioabsorbable; Bioresorbable; Scaffold

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

  The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).

  ≤ 7 days post index procedure (In hospital)

• Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

  The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.

  0 to 30 days

• Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

  Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).

  0 to 180 days

• Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)

  Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).

  0 to 1 year

Secondary Outcomes (60)

• Clinical Device Success

  On day 0 (immediate post-index procedure)

• Clinical Procedure Success

  On day 0 (immediate post-index procedure)

• Number of Participants With Cardiac Death

  ≤ 7 days post index procedure (In-hospital )

• Number of Participants With Myocardial Infarction (MI) - Per Protocol

  ≤ 7 days post index procedure (In-hospital )

• Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)

  ≤ 7 days post index procedure (In-hospital )

Study Arms (1)

ABSORB BVS

EXPERIMENTAL

Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease

Device: ABSORB BVS

Interventions

ABSORB BVS DEVICE

Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

ABSORB BVS

Eligibility Criteria

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

You may qualify if:

• Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
• Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
• Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1.
• Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
• Percutaneous intervention for lesions in the target vessel are allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure.

You may not qualify if:

• Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \> 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
• Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion \> 40% stenosed by visual estimation or side branch requiring predilatation.
• Total occlusion (TIMI flow 0), prior to wire passing.
• Target vessel(s) contains visible thrombus.
• Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
• Subject has received brachytherapy in any epicardial vessel (including side branches).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (56)

Instituto Cardiovascular de Buenos Aires-ICBA

Buenos Aires, 1428, Argentina

Location

Eastern Heart Clinic, The Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Wesley Hospital

Auchenflower, Queensland, Australia

Location

St. Vincent's Hospital

Melbourne, Victoria, 3065, Australia

Location

Monash Medical Center

Melbourne, Victoria, 3168, Australia

Location

Allgemeines Krankenhaus Linz

Linz, 4020, Austria

Location

Onze-Lieve VrouweZiekenhuis

Aalst, Belgium

Location

Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

São Paulo, 04012-180, Brazil

Location

Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein

São Paulo, 05652-901, Brazil

Location

Instituto Coração Triângulo Mineiro

Uberlândia, 38400-368, Brazil

Location

Montreal Heart Institute

Montreal, H1T 1C8, Canada

Location

University of Ottawa Heart Institute

Ottawa, K1Y 4W7, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V4G5, Canada

Location

St. Michael's Hospital

Toronto, M5B 1W8, Canada

Location

Prince of Wales Hospital

Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, China

Location

Århus University Hospital

Århus N, 8200, Denmark

Location

Institut Jacques Cartier (ICPS)

Massy, 91300, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Hopital De Rangueil - CHU

Toulouse, 31403, France

Location

Charité Berlin Campus Steglitz

Berlin, 12203, Germany

Location

Uni.Klinikum Heidelberg

Heidelberg, 69115, Germany

Location

Apollo Hospital

Hyderabaad, Andhar Pradesh, 500033, India

Location

CARE Hospital

Hyderabaad, Andhra Pradesh, 500034, India

Location

SAL Hospital And Medical Institute

Ahmedabad, 380054, India

Location

Care Institute of Medical Sciences

Ahmedabad, 380060, India

Location

Madras Medical Mission

Chennai, 600 037, India

Location

Medanta -The Medicity

Gūrgaon, 122001, India

Location

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, 226014, India

Location

Escorts Heart Institute & Research Centre

New Delhi, 110 070, India

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Catanzaro University Hospital

Catanzaro, 88100, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Teikyo University

Tokyo, Itabashi, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Location

Saiseikai Yokohama City Eastern Hospital

Yokohama, Kanagawa, Japan

Location

Kyoto University Hospital

Kyoto, Kansai, Japan

Location

Mitsui Memorial Hospital

Chiyoda-ku, 101-8643, Japan

Location

Institute Jantung Negara

Kuala Lumpur, Malaysia

Location

Catharina ZH Eindhoven

Eindhoven, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Mercy Angiography Unit

Auckland, 1023, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

University Hospital Krakow

Krakow, 31-501, Poland

Location

National University Hospital

Singapore, 119228, Singapore

Location

Sunninghill Hospital

Johannesburg, South Africa

Location

Clinico San Carlos

Madrid, Spain

Location

La Paz

Madrid, Spain

Location

Hospital do Meixoeiro

Pontevedra, 36200, Spain

Location

Lund University Hospital

Lund, 221 85, Sweden

Location

Inselspital Bern, Kardiologie

Bern, 3010, Switzerland

Location

Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Glenfield Hospital

Leicester, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Related Publications (7)

• Costa JR Jr, Abizaid A, Whitbourn R, Serruys PW, Jepson N, Steinwender C, Stuteville M, Ediebah D, Sudhir K, Bartorelli AL; ABSORB EXTEND investigators. Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):E1-E7. doi: 10.1002/ccd.27715. Epub 2018 Oct 4.

  PMID: 30286520 DERIVED

• Moriyama N, Shishido K, Tanaka Y, Yokota S, Hayashi T, Miyashita H, Koike T, Yokoyama H, Takada T, Nishimoto T, Ochiai T, Tobita K, Yamanaka F, Mizuno S, Murakami M, Takahashi S, Saito S. Neoatherosclerosis 5 Years After Bioresorbable Vascular Scaffold Implantation. J Am Coll Cardiol. 2018 May 1;71(17):1882-1893. doi: 10.1016/j.jacc.2018.02.051.

  PMID: 29699614 DERIVED

• Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.

  PMID: 26585622 DERIVED

• Abizaid A, Ribamar Costa J Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2015 Apr;10(12):1396-401. doi: 10.4244/EIJV10I12A243.

  PMID: 24769555 DERIVED

• Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.

  PMID: 24746650 DERIVED

• Gogas BD, King SB 3rd, Timmins LH, Passerini T, Piccinelli M, Veneziani A, Kim S, Molony DS, Giddens DP, Serruys PW, Samady H. Biomechanical assessment of fully bioresorbable devices. JACC Cardiovasc Interv. 2013 Jul;6(7):760-1. doi: 10.1016/j.jcin.2013.04.008. No abstract available.

  PMID: 23866188 DERIVED

• Muramatsu T, Onuma Y, Garcia-Garcia HM, Farooq V, Bourantas CV, Morel MA, Li X, Veldhof S, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW; ABSORB-EXTEND Investigators. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv. 2013 Mar;6(3):247-57. doi: 10.1016/j.jcin.2012.10.013.

  PMID: 23517836 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Susan Veldhof
• Organization: Abbott Vascular International BVBA

susan.veldhof@av.abbott.com

+31653428610

Study Officials

• Alexandre Abizaid, MD

  Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

  PRINCIPAL INVESTIGATOR

• Patrick Serruys, MD

  Thoraxcenter-Erasmus University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 14, 2018
• Results First Posted: December 18, 2017

Record last verified: 2017-12

Locations

AU (1); GB (2); AR (1); BE (1); IT (2); JP (5); CA (4); NZ (2); SG (1); ZA (1); FR (3); IL (1); ES (3); BR (3); IN (8); NL (3); SE (1); CH (1); TW (2); DK (1); PL (1); MY (1); CN (2); DE (2)