• Ischemia Driven MACE [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; ] [ Designated as safety issue: Yes ]
• Ischemia driven Target Vessel Failure (TVF) [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; ] [ Designated as safety issue: Yes ]
• Acute success (clinical device and clinical procedure) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
• Ischemia Driven Target Lesion Revascularization (TLR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years; ] [ Designated as safety issue: Yes ]
• Ischemia Driven Target Vessel Revascularization (TVR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]

• • 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)

• In-stent Late Loss(LL) [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
• In-segment LL [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
• Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement) [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
• Distal LL (distal defined as within 5 mm of tissue distal to stent placement) [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
• In-stent and in-segment Angiographic Binary Restenosis (ABR) rate [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
• In-stent % Volume Obstruction (VO) [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
• Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]

• • 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

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.

• 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 100 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.
• 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
• 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)
• Multi-slice Spiral Computed Tomography (MSCT) is an optional procedure which may be carried out at 18 months post procedure
• 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.

• Coronary Disease
• Coronary Artery Disease
• Coronary Restenosis

• Tanimoto S, Serruys PW, Thuesen L, Dudek D, de Bruyne B, Chevalier B, Ormiston JA. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv. 2007 Oct 1;70(4):515-23.
• Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907.
• 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.
• [No authors listed] TCT Daily: ABSORB: bioabsorbable coronary stents successfully and safely deployed. J Interv Cardiol. 2007 Feb;20(1):36-7. No abstract available.
• Tanimoto S, Bruining N, van Domburg RT, Rotger D, Radeva P, Ligthart JM, Serruys PW. Late stent recoil of the bioabsorbable everolimus-eluting coronary stent and its relationship with plaque morphology. J Am Coll Cardiol. 2008 Nov 11;52(20):1616-20.

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

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)