A Prospective Multicenter Non-Blinded Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

Recruiting
99 years or below
All
Phase 3
10 participants needed
1 Location

Brief description of study

The primary safety objective is a composite of the number of Major Adverse Events (MAEs) occurring through 30 days post-procedure compared to the rate in subjects treated with the Relay Thoracic Stent-Graft in the U.S. Pivotal Trial (P110038). The primary effectiveness objective is a composite of the number of effectiveness criteria compared to that of subjects treated with the Relay Thoracic Stent-Graft in the U.S. Pivotal Trial (P110038). Primary Safety Endpoint: Composite of the following MAEs occurring through 30 days post-procedure compared to a Performance Goal (PG) established from the endovascular treatment arm of the U.S. Pivotal Trial (P110038): 1. Death 2. Stroke (excluding transient ischemic attack) 3. Paralysis (excludes paraparesis) Primary Effectiveness Endpoint: Composite of the following criteria whereby the effectiveness rate will be compared to a PG established from the endovascular treatment arm of the U.S. Pivotal Trial (P110038): 1. Technical success through 24 hours, defined as: Successful delivery of the device through the vasculature; Successful deployment of the device at the intended location; Absence of Type I or III endoleaks;a Patent stent-graft without significant stenosis; 2. Stent-graft patency through 12 months; 3. Absence of aneurysm rupture through 12 months; 4. Absence of Type I and III endoleak through 12 months; 5. Absence of stent fractures in the attachment zone through 12 months; 6. Absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months; 7. Absence of aneurysm expansion ( 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study; 8. Absence of stent-graft migration ( 10 mm) through 12 months, compared to the first post-procedural CT. The following will be assessed as secondary endpoints of the study: 1. Loss of stent-graft patency through 1 month and 6 months; 2. Aneurysm rupture through 1 month and 6 months; 3. All Endoleaks, evaluated individually, at 1 month, 6 months, and 12 months; 4. Stent fractures in the attachment zone through 1 month and 6 months; 5. Incidence of open or endovascular secondary interventions related to the device or treated pathology through 1 month and 6 months; 6. Aneurysm expansion ( 5 mm diameter increase) through 6 months compared to the first post-procedural CT; 7. Stent-graft migration ( 10 mm) through 6 months compared to the first post-procedural CT; 8. Individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss 1,000 cc through 6 months and 12 months; 9. Vascular access complications at the index procedure; 10.Clinical utility measures, including duration of procedure, transfusions required, length of hospital stay, and time in Intensive Care Unit (ICU).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 99 years or below
  • Gender: All
Updated on 14 Jun 2023. Study ID: 825909

Find a site

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact
Race
Ethnicity
Other language

Interested in the study

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center