NCT05187351

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 99 (estimated)
• Sponsor: Minneapolis Heart Institute Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Target Vessel Failure in Saphenous Vein Grafts
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
PROCEDURE	Percutaneous 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.

Timeline

• Start date: 2021-11-21
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2022-01-11
• Last updated: 2025-01-27

Locations

2 sites across 1 country: United States