Clinical trial NCT01023789: ABSORB EXTEND Clinical Investigation
Official title: ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Cardiovascular Disease
Keywords: Drug eluting stent
Stents
Angioplasty
Bioabsorbable
Bioresorbable
Scaffold
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.
* If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
* 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).

Primary outcomes:
measure: Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
timeFrame: ≤ 7 days post index procedure (In hospital)
measure: Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
timeFrame: 0 to 30 days
measure: Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
timeFrame: 0 to 180 days
measure: Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
timeFrame: 0 to 1 year
Secondary outcomes:
measure: Clinical Device Success
timeFrame: On day 0 (immediate post-index procedure)
measure: Clinical Procedure Success
timeFrame: On day 0 (immediate post-index procedure)
measure: Number of Participants With Cardiac Death
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Myocardial Infarction (MI) - Per Protocol
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
timeFrame: ≤ 7 days post index procedure (In-hospital )
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 30 days
measure: Number of Participants With Myocardial Infarction (MI) - Per Protocol
timeFrame: 0 to 30 days
measure: Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 0 to 30 days
measure: Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 0 to 30 days
measure: Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
timeFrame: 0 to 30 days
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 180 days
measure: Number of Participants With Myocardial Infarction (MI) - Per Protocol
timeFrame: 0 to 180 days
measure: Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 0 to 180 days
measure: Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 0 to 180 days
measure: Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
timeFrame: 0 to 180 days
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 1 year
measure: Number of Participants With Myocardial Infarction (MI) - Per Protocol
timeFrame: 0 to 1 year
measure: Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 0 to 1 year
measure: Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 0 to 1 year
measure: Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
timeFrame: 0 to 1 year
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 2 year
measure: Number of Participants With Myocardial Infarction (MI) - Per Protocol
timeFrame: 0 to 2 year
measure: Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 0 to 2 year
measure: Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 0 to 2 year
measure: Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
timeFrame: 0 to 2 year
measure: Number of Participants With Cardiac Death
timeFrame: 0 to 3 years
measure: Number of Participants With Myocardial Infarction (MI) - Per Protocol
timeFrame: 0 to 3 years
measure: Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
timeFrame: 0 to 3 years
measure: Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
timeFrame: 0 to 3 years
measure: Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
timeFrame: 0 to 3 years
measure: Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
timeFrame: ≤ 7 days post index procedure (In hospital)
measure: Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
timeFrame: 0 to 30 days
measure: Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
timeFrame: 0 to 180 days
measure: Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
timeFrame: 0 to 1 year
measure: Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
timeFrame: 0 to 2 years
measure: Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
timeFrame: 0 to 3 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
timeFrame: 0 to 2 years
measure: Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
timeFrame: 0 to 3 years
measure: Number of Participants With Scaffold Thrombosis (Early)
timeFrame: 0 to 30 days
measure: Number of Participants With Scaffold Thrombosis
timeFrame: 0 to 180 days
measure: Number of Participants With Scaffold Thrombosis (Late)
timeFrame: 31 - 365 days
measure: Number of Participants With Scaffold Thrombosis
timeFrame: 0 to 1 year
measure: Number of Participants With Scaffold Thrombosis (Very Late)
timeFrame: 366 days to 2 years
measure: Number of Participants With Scaffold Thrombosis
timeFrame: 0 to 2 years
measure: Number of Participants With Scaffold Thrombosis
timeFrame: 0 to 3 years
measure: Area Stenosis (%)
timeFrame: 18 months
measure: Minimum Lumen Area
timeFrame: 18 months
measure: Mean Vessel Area
timeFrame: 18 months
measure: Minimum Vessel Area
timeFrame: 18 months
measure: Maximum Vessel Area
timeFrame: 18 months
measure: Mean Lumen Area
timeFrame: 18 months
measure: Maximum Lumen Area
timeFrame: 18 months
measure: Mean Plaque Area
timeFrame: 18 months
measure: Minimum Plaque Area
timeFrame: 18 months
measure: Maximum Plaque Area
timeFrame: 18 months
measure: Mean Reference Area
timeFrame: 18 months
measure: Calculated Minimum Lumen Diameter
timeFrame: 18 months
measure: Calculated Diameter Stenosis
timeFrame: 18 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires-ICBA
city: Randwick
country: Australia
facility: Eastern Heart Clinic, The Prince of Wales Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Wesley Hospital
state: Queensland
city: Melbourne
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Center
state: Victoria
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz
city: Aalst
country: Belgium
facility: Onze-Lieve VrouweZiekenhuis
city: Sao Paulo
country: Brazil
facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein
city: Uberlandia
country: Brazil
facility: Instituto Coração Triângulo Mineiro
city: Montreal
country: Canada
facility: Montreal Heart Institute
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Århus N
country: Denmark
facility: Århus University Hospital
city: Massy
country: France
facility: Institut Jacques Cartier (ICPS)
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Hopital De Rangueil - CHU
city: Berlin
country: Germany
facility: Charité Berlin Campus Steglitz
city: Heidelberg
country: Germany
facility: Uni.Klinikum Heidelberg
city: Hyderabaad
country: India
facility: Apollo Hospital
state: Andhar Pradesh
city: Hyderabaad
country: India
facility: CARE Hospital
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: SAL Hospital And Medical Institute
city: Ahmedabad
country: India
facility: Care Institute of Medical Sciences
city: Chennai
country: India
facility: Madras Medical Mission
city: Gurgaon
country: India
facility: Medanta -The Medicity
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences
city: New Delhi
country: India
facility: Escorts Heart Institute & Research Centre
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Catanzaro
country: Italy
facility: Catanzaro University Hospital
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Tokyo
country: Japan
facility: Teikyo University
state: Itabashi
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohama City Eastern Hospital
state: Kanagawa
city: Kyoto
country: Japan
facility: Kyoto University Hospital
state: Kansai
city: Chiyoda-ku
country: Japan
facility: Mitsui Memorial Hospital
city: Kuala Lumpur
country: Malaysia
facility: Institute Jantung Negara
city: Eindhoven
country: Netherlands
facility: Catharina ZH Eindhoven
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Auckland
country: New Zealand
facility: Mercy Angiography Unit
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Krakow
country: Poland
facility: University Hospital Krakow
city: Singapore
country: Singapore
facility: National University Hospital
city: Johannesburg
country: South Africa
facility: Sunninghill Hospital
city: Madrid
country: Spain
facility: Clinico San Carlos
city: Madrid
country: Spain
facility: La Paz
city: Pontevedra
country: Spain
facility: Hospital do Meixoeiro
city: Lund
country: Sweden
facility: Lund University Hospital
city: Bern
country: Switzerland
facility: Inselspital Bern, Kardiologie
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
name: Alexandre Abizaid, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thoraxcenter-Erasmus University
name: Patrick Serruys, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.