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.
Study Type
OBSERVATIONAL
Enrollment
30
Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease
Skejby Sygehus
Aarhus, Denmark
Erasmus University Thorax Center
Rotterdam, Netherlands
Auckland City Hospital
Auckland, New Zealand
University Hospital
Krakow, Poland
Ischemia Driven MACE
Time frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Ischemia driven Target Vessel Failure (TVF)
Time frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;
Acute success (clinical device and clinical procedure)
Time frame: Acute
Ischemia Driven Target Lesion Revascularization (TLR)
Time frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years;
Ischemia Driven Target Vessel Revascularization (TVR)
Time frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years
In-stent Late Loss(LL)
Time frame: at 180 days and 2 years
In-segment LL
Time frame: at 180 days and 2 years
Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement)
Time frame: at 180 days and 2 years
Distal LL (distal defined as within 5 mm of tissue distal to stent placement)
Time frame: at 180 days and 2 years
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate
Time frame: at 180 days and 2 years
In-stent % Volume Obstruction (VO)
Time frame: at 180 days and 2 years
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Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection
Time frame: at 180 days and 2 years