The primary study objective of the NASA registry is to evaluate the 12-month incidence of target vessel failure (TVF) in patients who present with saphenous vein graft (SVG) lesions and undergo percutaneous coronary intervention (PCI) of the corresponding native coronary artery.
This is a phase IV, multi-center, single-arm, observational study evaluating the outcomes of native coronary artery PCI in patients presenting with severe SVG lesions. Subjects will undergo clinically-indicated PCI of the native coronary artery that supplies the territory subtended by the diseased SVG at the discretion of the treating physicians. The study team will screen and enroll patients after completion of index procedure.
Study Type
OBSERVATIONAL
Enrollment
99
This is a registry study that will enroll patients with a 50-100% de novo SVG lesion and treated with percutaneous coronary intervention of the corresponding native coronary artery using a SYNERGY stent.
Henry Ford Health System
Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Incidence of TVF in patients who present with SVG lesions and undergo PCI
Investigating the incidence of target vessel failure in patients with saphenous vein graft lesions who undergo PCI of the native coronary artery. or coronary bypass surgery, and tamponade requiring pericardiocentesis or surgery.
Time frame: 12 months
Evaluate the incidence of various endpoints of patients undergoing PCI of the native coronary artery after SVG lesion development
The following endpoints will be measured: procedural success and complications, all cause death and cardiac death, myocardial infarction during follow up, stent thrombosis, target lesion revascularization, target vessel revascularization, non-target vessel revascularization, the composite endpoint of any death, and myocardial infarction and target vessel revascularization (patient-oriented composite endpoint), the composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularization (device-oriented composite endpoint for target lesion failure), and stroke.
Time frame: 12 months
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