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Procedure

Thoraflex Hybrid and Relay Extension Post-Approval Study (EXTEND Trial)

N/A
Recruiting
Led By Martin Czerny
Research Sponsored by Vascutek Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the primary effectiveness endpoint will be measured at one-year after the index procedure.
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Aortic Dissection
  • Aortic Aneurysm
  • Thoracic Diseases
  • Dissecting Aneurysm
  • Thoracic Aortic Aneurysm
  • Thoracic Aortic Dissection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the primary effectiveness endpoint will be measured at one-year after the index procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the primary effectiveness endpoint will be measured at one-year after the index procedure. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint: Treatment Success
Primary Safety Endpoint is a composite of the following
Secondary study objectives
Secondary Safety Endpoints, Absence of the following
Secondary effectiveness endpoints will be reported

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Who is running the clinical trial?

Vascutek Ltd.Lead Sponsor
16 Previous Clinical Trials
5,545 Total Patients Enrolled
4 Trials studying Aortic Dissection
840 Patients Enrolled for Aortic Dissection
Bolton MedicalIndustry Sponsor
16 Previous Clinical Trials
2,651 Total Patients Enrolled
5 Trials studying Aortic Dissection
240 Patients Enrolled for Aortic Dissection
Martin CzernyPrincipal InvestigatorUniversity of Freiburg
Joseph E BavariaPrincipal InvestigatorJefferson Health and Sidney Kimmel Medical College
~133 spots leftby Dec 2035
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