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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01023789




Registration number
NCT01023789
Ethics application status
Date submitted
30/11/2009
Date registered
2/12/2009
Date last updated
14/02/2018

Titles & IDs
Public title
ABSORB EXTEND Clinical Investigation
Scientific 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
Secondary ID [1] 0 0
ACTRN12610000131055
Secondary ID [2] 0 0
09-386
Universal Trial Number (UTN)
Trial acronym
ABSORB EXTEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Ischemia 0 0
Coronary Artery Stenosis 0 0
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ABSORB BVS

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


Treatment: Devices: ABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Timepoint [1] 0 0
= 7 days post index procedure (In hospital)
Primary outcome [2] 0 0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Timepoint [2] 0 0
0 to 30 days
Primary outcome [3] 0 0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Timepoint [3] 0 0
0 to 180 days
Primary outcome [4] 0 0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Timepoint [4] 0 0
0 to 1 year
Secondary outcome [1] 0 0
Clinical Device Success
Timepoint [1] 0 0
On day 0 (immediate post-index procedure)
Secondary outcome [2] 0 0
Clinical Procedure Success
Timepoint [2] 0 0
On day 0 (immediate post-index procedure)
Secondary outcome [3] 0 0
Number of Participants With Cardiac Death
Timepoint [3] 0 0
= 7 days post index procedure (In-hospital )
Secondary outcome [4] 0 0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Timepoint [4] 0 0
= 7 days post index procedure (In-hospital )
Secondary outcome [5] 0 0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [5] 0 0
= 7 days post index procedure (In-hospital )
Secondary outcome [6] 0 0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [6] 0 0
= 7 days post index procedure (In-hospital )
Secondary outcome [7] 0 0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Timepoint [7] 0 0
= 7 days post index procedure (In-hospital )
Secondary outcome [8] 0 0
Number of Participants With Cardiac Death
Timepoint [8] 0 0
0 to 30 days
Secondary outcome [9] 0 0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Timepoint [9] 0 0
0 to 30 days
Secondary outcome [10] 0 0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [10] 0 0
0 to 30 days
Secondary outcome [11] 0 0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [11] 0 0
0 to 30 days
Secondary outcome [12] 0 0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Timepoint [12] 0 0
0 to 30 days
Secondary outcome [13] 0 0
Number of Participants With Cardiac Death
Timepoint [13] 0 0
0 to 180 days
Secondary outcome [14] 0 0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Timepoint [14] 0 0
0 to 180 days
Secondary outcome [15] 0 0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [15] 0 0
0 to 180 days
Secondary outcome [16] 0 0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [16] 0 0
0 to 180 days
Secondary outcome [17] 0 0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Timepoint [17] 0 0
0 to 180 days
Secondary outcome [18] 0 0
Number of Participants With Cardiac Death
Timepoint [18] 0 0
0 to 1 year
Secondary outcome [19] 0 0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Timepoint [19] 0 0
0 to 1 year
Secondary outcome [20] 0 0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [20] 0 0
0 to 1 year
Secondary outcome [21] 0 0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [21] 0 0
0 to 1 year
Secondary outcome [22] 0 0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Timepoint [22] 0 0
0 to 1 year
Secondary outcome [23] 0 0
Number of Participants With Cardiac Death
Timepoint [23] 0 0
0 to 2 year
Secondary outcome [24] 0 0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Timepoint [24] 0 0
0 to 2 year
Secondary outcome [25] 0 0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [25] 0 0
0 to 2 year
Secondary outcome [26] 0 0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [26] 0 0
0 to 2 year
Secondary outcome [27] 0 0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Timepoint [27] 0 0
0 to 2 year
Secondary outcome [28] 0 0
Number of Participants With Cardiac Death
Timepoint [28] 0 0
0 to 3 years
Secondary outcome [29] 0 0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Timepoint [29] 0 0
0 to 3 years
Secondary outcome [30] 0 0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [30] 0 0
0 to 3 years
Secondary outcome [31] 0 0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [31] 0 0
0 to 3 years
Secondary outcome [32] 0 0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Timepoint [32] 0 0
0 to 3 years
Secondary outcome [33] 0 0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Timepoint [33] 0 0
= 7 days post index procedure (In hospital)
Secondary outcome [34] 0 0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Timepoint [34] 0 0
0 to 30 days
Secondary outcome [35] 0 0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Timepoint [35] 0 0
0 to 180 days
Secondary outcome [36] 0 0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Timepoint [36] 0 0
0 to 1 year
Secondary outcome [37] 0 0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Timepoint [37] 0 0
0 to 2 years
Secondary outcome [38] 0 0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Timepoint [38] 0 0
0 to 3 years
Secondary outcome [39] 0 0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Timepoint [39] 0 0
0 to 2 years
Secondary outcome [40] 0 0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Timepoint [40] 0 0
0 to 3 years
Secondary outcome [41] 0 0
Number of Participants With Scaffold Thrombosis (Early)
Timepoint [41] 0 0
0 to 30 days
Secondary outcome [42] 0 0
Number of Participants With Scaffold Thrombosis
Timepoint [42] 0 0
0 to 180 days
Secondary outcome [43] 0 0
Number of Participants With Scaffold Thrombosis (Late)
Timepoint [43] 0 0
31 - 365 days
Secondary outcome [44] 0 0
Number of Participants With Scaffold Thrombosis
Timepoint [44] 0 0
0 to 1 year
Secondary outcome [45] 0 0
Number of Participants With Scaffold Thrombosis (Very Late)
Timepoint [45] 0 0
366 days to 2 years
Secondary outcome [46] 0 0
Number of Participants With Scaffold Thrombosis
Timepoint [46] 0 0
0 to 2 years
Secondary outcome [47] 0 0
Number of Participants With Scaffold Thrombosis
Timepoint [47] 0 0
0 to 3 years
Secondary outcome [48] 0 0
Area Stenosis (%)
Timepoint [48] 0 0
18 months
Secondary outcome [49] 0 0
Minimum Lumen Area
Timepoint [49] 0 0
18 months
Secondary outcome [50] 0 0
Mean Vessel Area
Timepoint [50] 0 0
18 months
Secondary outcome [51] 0 0
Minimum Vessel Area
Timepoint [51] 0 0
18 months
Secondary outcome [52] 0 0
Maximum Vessel Area
Timepoint [52] 0 0
18 months
Secondary outcome [53] 0 0
Mean Lumen Area
Timepoint [53] 0 0
18 months
Secondary outcome [54] 0 0
Maximum Lumen Area
Timepoint [54] 0 0
18 months
Secondary outcome [55] 0 0
Mean Plaque Area
Timepoint [55] 0 0
18 months
Secondary outcome [56] 0 0
Minimum Plaque Area
Timepoint [56] 0 0
18 months
Secondary outcome [57] 0 0
Maximum Plaque Area
Timepoint [57] 0 0
18 months
Secondary outcome [58] 0 0
Mean Reference Area
Timepoint [58] 0 0
18 months
Secondary outcome [59] 0 0
Calculated Minimum Lumen Diameter
Timepoint [59] 0 0
18 months
Secondary outcome [60] 0 0
Calculated Diameter Stenosis
Timepoint [60] 0 0
18 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Eastern Heart Clinic, The Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Wesley Hospital - Auchenflower
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [4] 0 0
Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
- Auchenflower
Recruitment postcode(s) [3] 0 0
3065 - Melbourne
Recruitment postcode(s) [4] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Belgium
State/province [3] 0 0
Aalst
Country [4] 0 0
Brazil
State/province [4] 0 0
Sao Paulo
Country [5] 0 0
Brazil
State/province [5] 0 0
Uberlandia
Country [6] 0 0
Canada
State/province [6] 0 0
Montreal
Country [7] 0 0
Canada
State/province [7] 0 0
Ottawa
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Canada
State/province [9] 0 0
Toronto
Country [10] 0 0
China
State/province [10] 0 0
Hong Kong
Country [11] 0 0
Denmark
State/province [11] 0 0
Århus N
Country [12] 0 0
France
State/province [12] 0 0
Massy
Country [13] 0 0
France
State/province [13] 0 0
Toulouse
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Heidelberg
Country [16] 0 0
India
State/province [16] 0 0
Andhar Pradesh
Country [17] 0 0
India
State/province [17] 0 0
Andhra Pradesh
Country [18] 0 0
India
State/province [18] 0 0
Ahmedabad
Country [19] 0 0
India
State/province [19] 0 0
Chennai
Country [20] 0 0
India
State/province [20] 0 0
Gurgaon
Country [21] 0 0
India
State/province [21] 0 0
Lucknow
Country [22] 0 0
India
State/province [22] 0 0
New Delhi
Country [23] 0 0
Israel
State/province [23] 0 0
Petah Tikva
Country [24] 0 0
Italy
State/province [24] 0 0
Catanzaro
Country [25] 0 0
Italy
State/province [25] 0 0
Milano
Country [26] 0 0
Japan
State/province [26] 0 0
Itabashi
Country [27] 0 0
Japan
State/province [27] 0 0
Kanagawa
Country [28] 0 0
Japan
State/province [28] 0 0
Kansai
Country [29] 0 0
Japan
State/province [29] 0 0
Chiyoda-ku
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuala Lumpur
Country [31] 0 0
Netherlands
State/province [31] 0 0
Eindhoven
Country [32] 0 0
Netherlands
State/province [32] 0 0
Rotterdam
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
Poland
State/province [35] 0 0
Krakow
Country [36] 0 0
Singapore
State/province [36] 0 0
Singapore
Country [37] 0 0
South Africa
State/province [37] 0 0
Johannesburg
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Pontevedra
Country [40] 0 0
Sweden
State/province [40] 0 0
Lund
Country [41] 0 0
Switzerland
State/province [41] 0 0
Bern
Country [42] 0 0
Taiwan
State/province [42] 0 0
Kaohsiung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taipei
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Leicester
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01023789
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Alexandre Abizaid, MD
Address 0 0
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01023789