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

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05187351
• Other study ID #: NASA
• Status: Recruiting
• Start date: November 21, 2021
• Est. completion date: January 2030

Study information

• Verified date: December 2021
• Source: Minneapolis Heart Institute Foundation
• Contact: Emmanouil Brilakis, MD, PhD
• Phone: 612-863-3852
• Email: emmanouil.brilakis[@]allina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older

2. Presentation with a 50-99% de novo SVG lesion 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

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

Procedure:
• Percutaneous coronary intervention of the native coronary artery with Synergy
This is a registry study that will enroll patients with a 50-99% de novo SVG lesion SVG lesion and treated with percutaneous coronary intervention of the corresponding native coronary artery using a SYNERGY stent.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of TVF in patients who present with SVG lesions and undergo PCI	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.	12 months
Secondary	Evaluate the incidence of various endpoints of patients undergoing PCI of the native coronary artery after SVG lesion development	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.	12 months