Status:
COMPLETED
ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Disease
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 conta...
Detailed Description
* Prospective, open-labeled Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm and lesion length ≥ 8 mm receiving a single 3.0 x 12 mm BVS Everolimus E...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00300131
Start Date
March 1 2006
End Date
July 1 2011
Last Update
September 13 2011
Active Locations (4)
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1
Skejby Sygehus
Aarhus, Denmark
2
Erasmus University Thorax Center
Rotterdam, Netherlands
3
Auckland City Hospital
Auckland, New Zealand
4
University Hospital
Krakow, Poland