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

Last updated: January 22, 2025
Sponsor: Minneapolis Heart Institute Foundation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Open Heart Surgery

Treatment

Percutaneous coronary intervention of the native coronary artery with Synergy

Clinical Study ID

NCT05187351
NASA
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years or older

  2. Presentation with a 50-100% de novo SVG lesion that is considered to cause clinicalsymptoms and is treated with percutaneous coronary intervention of the correspondingnative coronary artery using a SYNERGY stent.

  3. Has provided informed consent and agrees to participate

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 99
Treatment Group(s): 1
Primary Treatment: Percutaneous coronary intervention of the native coronary artery with Synergy
Phase:
Study Start date:
November 21, 2021
Estimated Completion Date:
January 31, 2030

Study 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.

Connect with a study center

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    MInneapolis, Minnesota 55407
    United States

    Site Not Available

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