absorb clinical investigation, cohort a (absorb a) everolimus eluting coronary stent system clinical investigation

Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis

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.

* 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. * 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 and again between 4 and 5 year follow up. * 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.

Eligibility criteria:
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)

Keywords: bioabsorbable coronary stent everolimus drug eluting stents stents angioplasty coronary artery disease total coronary occlusion coronary artery restenosis stent thrombosis vascular disease myocardial ischemia coronary artery stenosis