Status:
ACTIVE_NOT_RECRUITING
Native Coronary Artery Instead of SAphenous Vein Graft Intervention for Treatment of Significant Saphenous Vein Graft Lesions
Lead Sponsor:
Minneapolis Heart Institute Foundation
Conditions:
Target Vessel Failure in Saphenous Vein Grafts
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
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 percut...
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 clinicall...
Eligibility Criteria
Inclusion
- 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
- 1\. Known comorbidities/ conditions that, in the opinion of the investigator, limit life expectancy to less than 1 year
Key Trial Info
Start Date :
November 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT05187351
Start Date
November 21 2021
End Date
January 1 2030
Last Update
January 27 2025
Active Locations (2)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202
2
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407