Thoraflex Hybrid and Relay Extension Post-Approval Study (EXTEND Trial)
Recruiting in Palo Alto (17 mi)
+26 other locations
Overseen ByMartin Czerny
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vascutek Ltd.
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta.
Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site.
Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.
Eligibility Criteria
Participant Groups
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Baylor College of Medicine - St. Luke'sHouston, TX
Mount Sinai Health SystemNew York, NY
UT Dell Medical / Ascension Texas CardiovascularAustin, TX
Ascension St. Vincent Heart CenterIndianapolis, IN
More Trial Locations
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Who is running the clinical trial?
Vascutek Ltd.Lead Sponsor
Bolton MedicalIndustry Sponsor