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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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
812
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01023789