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

NCT05187351 | Active Not Recruiting

• 1 other identifier: NASA
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 2

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.

Conditions

Target Vessel Failure in Saphenous Vein Grafts; Percutaneous Coronary Intervention

Keywords

Target Vessel Failure (TVF); Saphenous Vein Graft (SVG)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  12 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead

Study Sites (2)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 11, 2022
• Study Start: November 21, 2021
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)