ABSORB EXTEND Clinical Investigation

NCT ID: NCT01023789

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 812 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2016-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABSORB BVS

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

Group Type: EXPERIMENTAL

ABSORB BVS

Intervention Type: DEVICE

Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

Interventions

ABSORB BVS

Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Abizaid, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

Patrick Serruys, MD

Role: STUDY_CHAIR

Thoraxcenter-Erasmus University

Locations

Instituto Cardiovascular de Buenos Aires-ICBA

Buenos Aires, , Argentina

Eastern Heart Clinic, The Prince of Wales Hospital

Randwick, New South Wales, Australia

Wesley Hospital

Auchenflower, Queensland, Australia

St. Vincent's Hospital

Melbourne, Victoria, Australia

Monash Medical Center

Melbourne, Victoria, Australia

Allgemeines Krankenhaus Linz

Linz, , Austria

Onze-Lieve VrouweZiekenhuis

Aalst, , Belgium

Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

São Paulo, , Brazil

Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein

São Paulo, , Brazil

Instituto Coração Triângulo Mineiro

Uberlândia, , Brazil

Montreal Heart Institute

Montreal, , Canada

University of Ottawa Heart Institute

Ottawa, , Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, , Canada

St. Michael's Hospital

Toronto, , Canada

Prince of Wales Hospital

Hong Kong, , China

Queen Mary Hospital

Hong Kong, , China

Århus University Hospital

Århus N, , Denmark

Institut Jacques Cartier (ICPS)

Massy, , France

Clinique Pasteur

Toulouse, , France

Hopital De Rangueil - CHU

Toulouse, , France

Charité Berlin Campus Steglitz

Berlin, , Germany

Uni.Klinikum Heidelberg

Heidelberg, , Germany

Apollo Hospital

Hyderabaad, Andhar Pradesh, India

CARE Hospital

Hyderabaad, Andhra Pradesh, India

SAL Hospital And Medical Institute

Ahmedabad, , India

Care Institute of Medical Sciences

Ahmedabad, , India

Madras Medical Mission

Chennai, , India

Medanta -The Medicity

Gurgaon, , India

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, , India

Escorts Heart Institute & Research Centre

New Delhi, , India

Rabin Medical Center

Petah Tikva, , Israel

Catanzaro University Hospital

Catanzaro, , Italy

Centro Cardiologico Monzino

Milan, , Italy

Teikyo University

Tokyo, Itabashi, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Saiseikai Yokohama City Eastern Hospital

Yokohama, Kanagawa, Japan

Kyoto University Hospital

Kyoto, Kansai, Japan

Mitsui Memorial Hospital

Chiyoda-ku, , Japan

Institute Jantung Negara

Kuala Lumpur, , Malaysia

Catharina ZH Eindhoven

Eindhoven, , Netherlands

Erasmus Medical Center

Rotterdam, , Netherlands

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Mercy Angiography Unit

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

University Hospital Krakow

Krakow, , Poland

National University Hospital

Singapore, , Singapore

Sunninghill Hospital

Johannesburg, , South Africa

Clinico San Carlos

Madrid, , Spain

La Paz

Madrid, , Spain

Hospital do Meixoeiro

Pontevedra, , Spain

Lund University Hospital

Lund, , Sweden

Inselspital Bern, Kardiologie

Bern, , Switzerland

Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Glenfield Hospital

Leicester, , United Kingdom

King's College Hospital

London, , United Kingdom

Countries

Argentina; Australia; Austria; Belgium; Brazil; Canada; China; Denmark; France; Germany; India; Israel; Italy; Japan; Malaysia; Netherlands; New Zealand; Poland; Singapore; South Africa; Spain; Sweden; Switzerland; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30286520 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29699614 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26585622 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24769555 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24746650 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23866188 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23517836 (View on PubMed)

Other Identifiers

ACTRN12610000131055

Identifier Type: REGISTRY

Identifier Source: secondary_id

REFCTRI000460, 03-05-2010

Identifier Type: REGISTRY

Identifier Source: secondary_id

09-386

Identifier Type: -

Identifier Source: org_study_id