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

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.

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Key information

Conditions

Target Vessel Failure in Saphenous Vein Grafts Percutaneous Coronary Intervention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Health System, Detroit, Michigan, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years or older
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.
Has provided informed consent and agrees to participate

Exclusion criteria

Known comorbidities/ conditions that, in the opinion of the investigator, limit life expectancy to less than 1 year

Treatment and study plan

Percutaneous coronary intervention of the native coronary artery with Synergy

Procedure

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.

Primary outcomes

Incidence of TVF in patients who present with SVG lesions and undergo PCI

Time frame: 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 outcomes

Evaluate the incidence of various endpoints of patients undergoing PCI of the native coronary artery after SVG lesion development

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2030
Study completion: 2030
First posted: Jan 11, 2022
Registry last updated: Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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