ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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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 Eluting CSS containing 98 microgramme per cm² of surface area. Lesion length will be expanded to≥ 14 mm in length by visual estimation when 3.0 x 18 mm stent is available.
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Angiographic, Intravascular Ultrasound (IVUS), Intravascular Ultrasound- virtual histology (IVUS-VH) and Palpography follow-up will be carried out in all patients at 180 days and 2 years following the index procedure
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Optical Coherence Tomography (OCT) follow-up at 180 days and 2 years will be carried out in a subset of up to 10 patients in Cohorts A and B respectively who are enrolled in pre-determined clinical site(s)
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Multi-slice Spiral Computed Tomography (MSCT) is an optional procedure which may be carried out at 18 months post procedure and again between 4 and 5 year follow up.
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Additionally, coronary vasomotion test may be done at 2 years post procedure
Single patient Cohort of 30.
Pipeline products. Currently in development at Abbott Vascular. Not available for sale.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System |
Device: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease
Other Names:
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Outcome Measures
Primary Outcome Measures
- Ischemia Driven MACE [at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;]
- Ischemia driven Target Vessel Failure (TVF) [at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;]
- Acute success (clinical device and clinical procedure) [Acute]
- Ischemia Driven Target Lesion Revascularization (TLR) [at 30, 180, 270 days and 1, 2, 3, 4, 5 years;]
- Ischemia Driven Target Vessel Revascularization (TVR) [at 30, 180, 270 days and 1, 2, 3, 4, 5 years]
Secondary Outcome Measures
- In-stent Late Loss(LL) [at 180 days and 2 years]
- In-segment LL [at 180 days and 2 years]
- Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement) [at 180 days and 2 years]
- Distal LL (distal defined as within 5 mm of tissue distal to stent placement) [at 180 days and 2 years]
- In-stent and in-segment Angiographic Binary Restenosis (ABR) rate [at 180 days and 2 years]
- In-stent % Volume Obstruction (VO) [at 180 days and 2 years]
- Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection [at 180 days and 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
Target lesion must be located in a native epicardial vessel with visually estimated nominal vessel diameter of 3.0 mm
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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
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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
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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
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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 Criteria:
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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
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Lesion involving a bifurcation greater/equal 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
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Total occlusion (TIMI flow 0), prior to wire passing
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The target vessel contains visible thrombus
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Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion
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Patient has received brachytherapy in any epicardial vessel (including side branches)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Skejby Sygehus | Aarhus | Denmark | ||
| 2 | Erasmus University Thorax Center | Rotterdam | Netherlands | ||
| 3 | Auckland City Hospital | Auckland | New Zealand | ||
| 4 | University Hospital | Krakow | Poland |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: John Ormiston, MD, Auckland City Hospital
- Principal Investigator: Patrick Serruys, MD, Erasmus University Thorax Center
Study Documents (Full-Text)
None provided.More Information
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.
- TCT Daily: ABSORB: bioabsorbable coronary stents successfully and safely deployed. J Interv Cardiol. 2007 Feb;20(1):36-7.
- 05-370