The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.
Currently in development at Abbott Vascular. Not available for sale in the United States.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient must be at least 18 years of age.
✓. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
✓. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
✓. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
✓. Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)
✓. Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure
✓. Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
✓. Target lesion(s) must measure ≤ 14 mm in length by visual estimation
Exclusion criteria
✕. Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure
What they're measuring
1
Hierarchical Major Adverse Cardiac Event (MACE)
Timeframe: 30 days
2
Hierarchical Major Adverse Cardiac Event (MACE)
Timeframe: 1 year
3
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days
Timeframe: 180 days
4
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year
✕. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure
✕. Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
✕. The patient is currently experiencing clinical symptoms consistent with AMI
✕. Patient has current unstable arrhythmias
✕. Patient has a known left ventricular ejection fraction (LVEF) \< 30%
✕. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
✕. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure