None listed
Conditions
Brief summary
The primary objective of the ABSORB EXTEND trial is to continue the assessment of the safety and performance of the Bioresorbable Vascular Solutions Everolimus Eluting Coronary Scaffold System.
Interventions
Bioresorbable Vascular Solutions Everolimus Eluting Coronary Scaffold System (BVS EECSS). Percutaneous Coronary Intervention (PCI) is commonly known as coronary angioplasty. Typically, PCI is performed by threading a slender balloon-tipped tube, a catheter, from an artery in the groin to a trouble spot in an artery of the heart. The balloon is then inflated, compressing the plaque and dilating (widening) the narrowed coronary artery so that blood can flow more easily. During PCI for this study,
Bioresorbable Vascular Solutions Everolimus Eluting Coronary Scaffold System (BVS EECSS). Percutaneous Coronary Intervention (PCI) is commonly known as coronary angioplasty. Typically, PCI is performed by threading a slender balloon-tipped tube, a catheter, from an artery in the groin to a trouble spot in an artery of the heart. The balloon is then inflated, compressing the plaque and dilating (widening) the narrowed coronary artery so that blood can flow more easily. During PCI for this study, the BVS EECSS is then placed in the coronary artery to support the previously narrowed area. The BVS EECSS will remain in place until the bioresorbtion process is complete, your physician will discuss this process with you. The duration of the PCI procedure will depend on many factors, and is typically less than 2 hours. Your physician will discuss those factors and the length of your procedure with you. Optical Coherence Tomography (OCT) subgroup definition: - A subgroup of up to 50 subjects who: - Have their procedures performed at selected investigational sites with OCT capability; and - Receive planned overlapping BVS treatment of the target lesion. - The need for planned overlapping of BVS will be determined by the investigator up to the time of the index procedure. - Angiography, Intravascular Ultrasound (IVUS) and OCT are required for all subjects in the OCT subgroup post-procedure and at 2-year follow-up Multi-Slice Computed Tomography subgroup definition: - A subgroup of up to 100 subjects who: - Have their procedures performed at selected investigational sites having both OCT and MSCT capability; and - Receive at least one BVS EECSS in the target lesion. MSCT imaging and clinical follow-up at 18 months is required for all subjects in the MSCT subgroup.
Sponsors
Abbott Vascular
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Up to two de novo lesions can be treated, each located in a separate native epicardial vessel. Target lesion(s) must measure <= 28 mm in length by Qualitative Coronary Angiography (QCA), or by visual estimation if on line QCA is not available. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a Thrombolysis in Myocardial Infarction (TIMI) flow of >= 1. If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels. Percutaneous interventions for lesions in a non-target vessel are allowed if done >= 30 days prior to or if planned to be done > 6 months after the index procedure. Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.
Exclusion criteria
Lesion(s) 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(s) involving a bifurcation with side branch vessel >= 2 mm in diameter, ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation. Total occlusion (TIMI flow 0), prior to wire passing. Target vessel(s) contains visible thrombus. Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s). Subject has received brachytherapy in any epicardial vessel (including side branches).
Outcome results
None listed