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

Active, not recruiting

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

• Registration Number: NCT05187351
• Lead Sponsor: Minneapolis Heart Institute Foundation

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.

Study Timeline

• Study Start: 2021-11-21
• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2022-01-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Minneapolis Heart Institute Foundation; 🇺🇸 MInneapolis, Minnesota, United States