Percutaneous Coronary Intervention, Target Vessel Failure in Saphenous Vein Grafts
Conditions
Keywords
Target Vessel Failure (TVF), Saphenous Vein Graft (SVG)
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPercutaneous coronary intervention of the native coronary artery with Synergy
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.
Sponsors
Minneapolis Heart Institute Foundation
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Presentation with a 50-100% de novo SVG lesion that is considered to cause clinical symptoms and is treated with percutaneous coronary intervention of the corresponding native coronary artery using a SYNERGY stent. 3. Has provided informed consent and agrees to participate
Exclusion criteria
1\. Known comorbidities/ conditions that, in the opinion of the investigator, limit life expectancy to less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of TVF in patients who present with SVG lesions and undergo PCI | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the incidence of various endpoints of patients undergoing PCI of the native coronary artery after SVG lesion development | 12 months | 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. |
Countries
United States
Outcome results
None listed