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

July 20, 2022 updated by: Minneapolis Heart Institute Foundation
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.

Study Overview

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 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.

Study Type

Observational

Enrollment (Anticipated)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
          • Khaldoon Alaswad, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2021

Primary Completion (Anticipated)

January 1, 2030

Study Completion (Anticipated)

January 1, 2030

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • NASA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Percutaneous Coronary Intervention

Clinical Trials on Percutaneous coronary intervention of the native coronary artery with Synergy

Subscribe