Thoraflex Hybrid and Relay Extension Post-Approval Study

(EXTEND Trial)

Recruiting at 26 trial locations

Overseen By Donna McDougall

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vascutek Ltd.

Disqualifiers: Medical, social, psychological problems

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate

200 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Joseph E Bavaria

Principal Investigator

Jefferson Health and Sidney Kimmel Medical College

Martin Czerny

Principal Investigator

University of Freiburg

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient will undergo treatment with a Thoraflex Hybrid device. If a patient requires an extension procedure due to the extent of aortic disease, a RelayPro NBS Stent-graft should be placed inside the distal end of the previously placed Thoraflex Hybrid device via a retrograde approach. This may be part of the same or a two-stage procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft

Immediate

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• RelayPro NBS stent-graft
• Thoraflex Hybrid device

Who Is Running the Clinical Trial?

Vascutek Ltd.

Lead Sponsor

Trials

18

Recruited

5,900+

Bolton Medical

Industry Sponsor

Trials

17

Recruited

2,900+