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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00300131




Registration number
NCT00300131
Ethics application status
Date submitted
7/03/2006
Date registered
8/03/2006
Date last updated
13/09/2011

Titles & IDs
Public title
ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
Scientific title
Bioabsorbable Vascular Solutions First in Man Clinical Investigation: A Clinical Evaluation of the Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With Single de Novo Native Coronary Artery Lesions
Secondary ID [1] 0 0
05-370
Universal Trial Number (UTN)
Trial acronym
ABSORB A
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Bioabsorbable Everolimus Eluting Coronary Stent

1 - Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System


Treatment: Devices: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation stent 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
Ischemia Driven MACE
Timepoint [1] 0 0
at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Primary outcome [2] 0 0
Ischemia driven Target Vessel Failure (TVF)
Timepoint [2] 0 0
at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Primary outcome [3] 0 0
Acute success (clinical device and clinical procedure)
Timepoint [3] 0 0
Acute
Primary outcome [4] 0 0
Ischemia Driven Target Lesion Revascularization (TLR)
Timepoint [4] 0 0
at 30, 180, 270 days and 1, 2, 3, 4, 5 years;
Primary outcome [5] 0 0
Ischemia Driven Target Vessel Revascularization (TVR)
Timepoint [5] 0 0
at 30, 180, 270 days and 1, 2, 3, 4, 5 years
Secondary outcome [1] 0 0
In-stent Late Loss(LL)
Timepoint [1] 0 0
at 180 days and 2 years
Secondary outcome [2] 0 0
In-segment LL
Timepoint [2] 0 0
at 180 days and 2 years
Secondary outcome [3] 0 0
Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement)
Timepoint [3] 0 0
at 180 days and 2 years
Secondary outcome [4] 0 0
Distal LL (distal defined as within 5 mm of tissue distal to stent placement)
Timepoint [4] 0 0
at 180 days and 2 years
Secondary outcome [5] 0 0
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
Timepoint [5] 0 0
at 180 days and 2 years
Secondary outcome [6] 0 0
In-stent % Volume Obstruction (VO)
Timepoint [6] 0 0
at 180 days and 2 years
Secondary outcome [7] 0 0
Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection
Timepoint [7] 0 0
at 180 days and 2 years

Eligibility
Key inclusion criteria
Target lesion must be located in a native epicardial vessel with visually estimated nominal
vessel diameter of 3.0 mm

- Target lesion must measure less/equal 8 mm in length by visual estimation for 3.0 x 12
mm, expanded to less/equal 14 mm in length by visual estimation when 3.0 x 18 mm stent
is available

- The 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 greater/equal 1

- Non-Clinical Investigation, percutaneous intervention for lesions in a non-target
vessel is allowed if done more/equal 90 days prior to or if planned to be done 6
months after the index procedure

- Non-Clinical Investigation, percutaneous intervention for lesions in the target vessel
is 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
- 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 involving a bifurcation greater/equal 2 mm in diameter and ostial lesion > 40%
stenosed by visual estimation or side branch requiring predilatation

- Total occlusion (TIMI flow 0), prior to wire passing

- The target vessel contains visible thrombus

- Another clinically significant lesion is located in the same epicardial vessel
(including side branch) as the target lesion

- Patient has received brachytherapy in any epicardial vessel (including side branches)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aarhus
Country [2] 0 0
Netherlands
State/province [2] 0 0
Rotterdam
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Poland
State/province [4] 0 0
Krakow

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

Ethics approval
Ethics application status

Summary
Brief summary
Prospective, open-labeled First in Man Clinical Investigation enrolling patients with
visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x
18 mm BVS EECSS containing 98 microgramme per cm² of surface area.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00300131
Trial related presentations / publications
Ormiston JA, Webster MW, Armstrong G. First-in-human implantation of a fully bioabsorbable drug-eluting stent: the BVS poly-L-lactic acid everolimus-eluting coronary stent. Catheter Cardiovasc Interv. 2007 Jan;69(1):128-31. doi: 10.1002/ccd.20895.
TCT Daily: ABSORB: bioabsorbable coronary stents successfully and safely deployed. J Interv Cardiol. 2007 Feb;20(1):36-7. doi: 10.1111/j.1540-8183.2007.00235.x. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
John Ormiston, MD
Address 0 0
Auckland City Hospital
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