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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00856856




Registration number
NCT00856856
Ethics application status
Date submitted
27/02/2009
Date registered
6/03/2009
Date last updated
7/02/2019

Titles & IDs
Public title
ABSORB Clinical Investigation, Cohort B
Scientific title
A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
Secondary ID [1] 0 0
05-370 Cohort B
Universal Trial Number (UTN)
Trial acronym
ABSORB B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Bioabsorbable Everolimus Eluting Coronary Stent

Experimental: Absorb stent - Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)


Treatment: Devices: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hierarchical Major Adverse Cardiac Event (MACE)
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Hierarchical Major Adverse Cardiac Event (MACE)
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days
Timepoint [3] 0 0
180 days
Primary outcome [4] 0 0
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year
Timepoint [4] 0 0
1 year
Secondary outcome [1] 0 0
Clinical Device Success (Per Lesion)
Timepoint [1] 0 0
On day 0 (the day of procedure)
Secondary outcome [2] 0 0
Clinical Procedure Success (Per Patient)
Timepoint [2] 0 0
On day 0 (the day of procedure)
Secondary outcome [3] 0 0
Hierarchical Major Adverse Cardiac Event (MACE)
Timepoint [3] 0 0
180 days
Secondary outcome [4] 0 0
Hierarchical Major Adverse Cardiac Event (MACE)
Timepoint [4] 0 0
270 days
Secondary outcome [5] 0 0
Hierarchical Major Adverse Cardiac Event (MACE)
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Hierarchical Major Adverse Cardiac Event (MACE)
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Hierarchical Major Adverse Cardiac Event (MACE)
Timepoint [7] 0 0
4 years
Secondary outcome [8] 0 0
Hierarchical Major Adverse Cardiac Event (MACE)
Timepoint [8] 0 0
5 years
Secondary outcome [9] 0 0
Hierarchical Target Vessel Failure (TVF)
Timepoint [9] 0 0
30 days
Secondary outcome [10] 0 0
Hierarchical Target Vessel Failure (TVF)
Timepoint [10] 0 0
180 days
Secondary outcome [11] 0 0
Hierarchical Target Vessel Failure (TVF)
Timepoint [11] 0 0
270 days
Secondary outcome [12] 0 0
Hierarchical Target Vessel Failure (TVF)
Timepoint [12] 0 0
1 year
Secondary outcome [13] 0 0
Hierarchical Target Vessel Failure (TVF)
Timepoint [13] 0 0
2 years
Secondary outcome [14] 0 0
Hierarchical Target Vessel Failure (TVF)
Timepoint [14] 0 0
3 years
Secondary outcome [15] 0 0
Hierarchical Target Vessel Failure (TVF)
Timepoint [15] 0 0
4 years
Secondary outcome [16] 0 0
Hierarchical Target Vessel Failure (TVF)
Timepoint [16] 0 0
5 years
Secondary outcome [17] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [17] 0 0
30 days
Secondary outcome [18] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [18] 0 0
180 days
Secondary outcome [19] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [19] 0 0
270 days
Secondary outcome [20] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [20] 0 0
1 year
Secondary outcome [21] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [21] 0 0
2 years
Secondary outcome [22] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [22] 0 0
3 years
Secondary outcome [23] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [23] 0 0
4 years
Secondary outcome [24] 0 0
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Timepoint [24] 0 0
5 years
Secondary outcome [25] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [25] 0 0
30 days
Secondary outcome [26] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [26] 0 0
180 days
Secondary outcome [27] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [27] 0 0
270 days
Secondary outcome [28] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [28] 0 0
1 year
Secondary outcome [29] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [29] 0 0
2 years
Secondary outcome [30] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [30] 0 0
3 years
Secondary outcome [31] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [31] 0 0
4 years
Secondary outcome [32] 0 0
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Timepoint [32] 0 0
5 years
Secondary outcome [33] 0 0
Cardiac Death
Timepoint [33] 0 0
30 days
Secondary outcome [34] 0 0
Cardiac Death
Timepoint [34] 0 0
1 year
Secondary outcome [35] 0 0
Cardiac Death
Timepoint [35] 0 0
2 years
Secondary outcome [36] 0 0
Cardiac Death
Timepoint [36] 0 0
3 years
Secondary outcome [37] 0 0
Cardiac Death
Timepoint [37] 0 0
4 years
Secondary outcome [38] 0 0
Cardiac Death
Timepoint [38] 0 0
5 years
Secondary outcome [39] 0 0
Myocardial Infarction
Timepoint [39] 0 0
30 days
Secondary outcome [40] 0 0
Myocardial Infarction
Timepoint [40] 0 0
1 year
Secondary outcome [41] 0 0
Myocardial Infarction
Timepoint [41] 0 0
2 years
Secondary outcome [42] 0 0
Myocardial Infarction
Timepoint [42] 0 0
3 years
Secondary outcome [43] 0 0
Myocardial Infarction
Timepoint [43] 0 0
4 years
Secondary outcome [44] 0 0
Myocardial Infarction
Timepoint [44] 0 0
5 years
Secondary outcome [45] 0 0
Scaffold Thrombosis
Timepoint [45] 0 0
30 days
Secondary outcome [46] 0 0
Scaffold Thrombosis
Timepoint [46] 0 0
1 year
Secondary outcome [47] 0 0
Scaffold Thrombosis
Timepoint [47] 0 0
2 years
Secondary outcome [48] 0 0
Scaffold Thrombosis
Timepoint [48] 0 0
3 years
Secondary outcome [49] 0 0
Scaffold Thrombosis
Timepoint [49] 0 0
4 years
Secondary outcome [50] 0 0
Scaffold Thrombosis
Timepoint [50] 0 0
5 years
Secondary outcome [51] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years
Timepoint [51] 0 0
2 years
Secondary outcome [52] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years
Timepoint [52] 0 0
3 years
Secondary outcome [53] 0 0
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years
Timepoint [53] 0 0
5 years
Secondary outcome [54] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days
Timepoint [54] 0 0
180 days
Secondary outcome [55] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year
Timepoint [55] 0 0
1 year
Secondary outcome [56] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years
Timepoint [56] 0 0
2 years
Secondary outcome [57] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years
Timepoint [57] 0 0
3 years
Secondary outcome [58] 0 0
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years
Timepoint [58] 0 0
5 years
Secondary outcome [59] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days
Timepoint [59] 0 0
180 days
Secondary outcome [60] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year
Timepoint [60] 0 0
1 year
Secondary outcome [61] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years
Timepoint [61] 0 0
2 years
Secondary outcome [62] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years
Timepoint [62] 0 0
3 years
Secondary outcome [63] 0 0
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years
Timepoint [63] 0 0
5 years
Secondary outcome [64] 0 0
In-scaffold Angiographic Binary Restenosis (ABR)
Timepoint [64] 0 0
180 days
Secondary outcome [65] 0 0
In-scaffold Angiographic Binary Restenosis (ABR)
Timepoint [65] 0 0
1 year
Secondary outcome [66] 0 0
In-scaffold Angiographic Binary Restenosis (ABR)
Timepoint [66] 0 0
2 years
Secondary outcome [67] 0 0
In-scaffold Angiographic Binary Restenosis (ABR)
Timepoint [67] 0 0
3 years
Secondary outcome [68] 0 0
In-scaffold Angiographic Binary Restenosis (ABR)
Timepoint [68] 0 0
5 years
Secondary outcome [69] 0 0
Persisting Dissection
Timepoint [69] 0 0
180 days
Secondary outcome [70] 0 0
Persisting Dissection
Timepoint [70] 0 0
1 year
Secondary outcome [71] 0 0
Persisting Dissection
Timepoint [71] 0 0
2 years
Secondary outcome [72] 0 0
Persisting Dissection
Timepoint [72] 0 0
3 years
Secondary outcome [73] 0 0
Persisting Dissection
Timepoint [73] 0 0
5 years
Secondary outcome [74] 0 0
In-scaffold Percent Diameter Stenosis (%DS)
Timepoint [74] 0 0
180 days
Secondary outcome [75] 0 0
In-scaffold Percent Diameter Stenosis (%DS)
Timepoint [75] 0 0
1 year
Secondary outcome [76] 0 0
In-scaffold Percent Diameter Stenosis (%DS)
Timepoint [76] 0 0
2 years
Secondary outcome [77] 0 0
In-scaffold Percent Diameter Stenosis (%DS)
Timepoint [77] 0 0
3 years
Secondary outcome [78] 0 0
In-scaffold Percent Diameter Stenosis (%DS)
Timepoint [78] 0 0
5 years
Secondary outcome [79] 0 0
Aneurysm
Timepoint [79] 0 0
180 days
Secondary outcome [80] 0 0
Aneurysm
Timepoint [80] 0 0
1 year
Secondary outcome [81] 0 0
Aneurysm
Timepoint [81] 0 0
2 years
Secondary outcome [82] 0 0
Aneurysm
Timepoint [82] 0 0
3 years
Secondary outcome [83] 0 0
Aneurysm
Timepoint [83] 0 0
5 years
Secondary outcome [84] 0 0
Thrombus
Timepoint [84] 0 0
180 days
Secondary outcome [85] 0 0
Thrombus
Timepoint [85] 0 0
1 year
Secondary outcome [86] 0 0
Thrombus
Timepoint [86] 0 0
2 years
Secondary outcome [87] 0 0
Thrombus
Timepoint [87] 0 0
3 years
Secondary outcome [88] 0 0
Thrombus
Timepoint [88] 0 0
5 years
Secondary outcome [89] 0 0
Vasomotion Analysis: In-scaffold Mean Luminal Diameter
Timepoint [89] 0 0
5 years
Secondary outcome [90] 0 0
Volume Obstruction (VO)
Timepoint [90] 0 0
180 days
Secondary outcome [91] 0 0
Volume Obstruction (VO)
Timepoint [91] 0 0
1 year
Secondary outcome [92] 0 0
Volume Obstruction (VO)
Timepoint [92] 0 0
2 year
Secondary outcome [93] 0 0
Volume Obstruction (VO)
Timepoint [93] 0 0
3 year
Secondary outcome [94] 0 0
Persisting Incomplete Apposition
Timepoint [94] 0 0
180 days
Secondary outcome [95] 0 0
Persisting Incomplete Apposition
Timepoint [95] 0 0
1 year
Secondary outcome [96] 0 0
Persisting Incomplete Apposition
Timepoint [96] 0 0
2 year
Secondary outcome [97] 0 0
Persisting Incomplete Apposition
Timepoint [97] 0 0
3 year
Secondary outcome [98] 0 0
Late Incomplete Apposition
Timepoint [98] 0 0
180 days
Secondary outcome [99] 0 0
Late Incomplete Apposition
Timepoint [99] 0 0
1 year
Secondary outcome [100] 0 0
Late Incomplete Apposition
Timepoint [100] 0 0
2 year
Secondary outcome [101] 0 0
Late Incomplete Apposition
Timepoint [101] 0 0
3 year

Eligibility
Key inclusion criteria
General inclusion criteria

1. Patient must be at least 18 years of age.
2. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
5. Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)
6. Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure

Angiographic Inclusion Criteria

1. Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
2. Target lesion(s) must measure = 14 mm in length by visual estimation
3. 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
4. If two target lesions meet the inclusion criteria they must be in different major epicardial vessels left anterior descending artery (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
5. If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/exclusion criteria
6. Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done = 90 days prior to or if planned to be done 6 months after the index procedure
7. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure

General
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
2. The patient is currently experiencing clinical symptoms consistent with AMI
3. Patient has current unstable arrhythmias
4. Patient has a known left ventricular ejection fraction (LVEF) < 30%
5. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
7. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
8. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
9. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated
10. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
11. Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell count of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
15. Patient has had a significant GI or urinary bleed within the past six months
16. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
17. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
18. Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
19. Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)
20. Patient has received brachytherapy in any epicardial vessel (including side branches)

Angiographic Exclusion Criteria

1. Target lesion(s) meets any of the following criteria:

1. Aorto-ostial location (within 3 mm)
2. Left main location
3. Located within 2 mm of the origin of the LAD or LCX
4. 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
5. Lesion involving a bifurcation = 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
6. Total occlusion (TIMI flow 0), prior to wire crossing
7. Excessive tortuosity proximal to or within the lesion
8. Extreme angulation (= 90%) proximal to or within the lesion
9. Heavy calcification
10. Restenotic from previous intervention
2. The target vessel contains visible thrombus
3. Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
4. Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)

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
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [2] 0 0
Monash Heart - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Denmark
State/province [2] 0 0
Aarhus
Country [3] 0 0
France
State/province [3] 0 0
Massy
Country [4] 0 0
Netherlands
State/province [4] 0 0
Eindhoven
Country [5] 0 0
Netherlands
State/province [5] 0 0
Rotterdam
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
New Zealand
State/province [7] 0 0
Christchurch
Country [8] 0 0
Poland
State/province [8] 0 0
Krakow
Country [9] 0 0
Switzerland
State/province [9] 0 0
Bern

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
Patrick Serruys, MD
Address 0 0
Erasmus Heart Center, Thorax Centrum
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/NCT00856856