Native Coronary Artery Instead of SAphenous Vein Graft Intervention for Treatment of Significant Saphenous Vein Graft Lesions

Minneapolis Heart Institute Foundation

Status: Active, not recruiting

Conditions: Percutaneous Coronary Intervention; Target Vessel Failure in Saphenous Vein Grafts

Treatments: Procedure: Percutaneous coronary intervention of the native coronary artery with Synergy

Study type: Observational

Funder types: Other

Identifiers

NCT05187351

NASA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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