Thoraflex Hybrid for Aortic Aneurysm

(EXTEND Trial)

Recruiting at 31 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?

This trial examines the effectiveness of the Thoraflex Hybrid device, a medical device for aortic repair, both alone and with the RelayPro NBS stent-graft, in individuals with aortic diseases affecting specific parts of the heart's main artery. The study aims to determine if these treatments can effectively manage the disease over time. Candidates for this trial include those receiving the Thoraflex Hybrid device, and possibly the RelayPro extension, particularly if they have aortic disease affecting the aortic arch or nearby areas. Participants will be monitored for 10 years post-device implantation to assess their health under typical care routines. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants the opportunity to contribute to significant research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Thoraflex Hybrid device and RelayPro NBS stent-graft are safe for treating aortic disease?

Research has shown that the Thoraflex Hybrid device is generally safe for most patients. In a study with 65 patients, 76.9% did not experience major issues such as death or severe stroke, indicating that most patients tolerated the device well.

The RelayPro NBS stent-graft has undergone testing in various studies to assess its safety and effectiveness for individuals with aortic diseases. Although specific numbers are not provided here, these studies emphasize ensuring the device's safety for patients.

Both devices have undergone thorough testing to ensure safety, which is crucial for anyone considering participation in a clinical trial involving these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Thoraflex Hybrid device is unique because it combines a graft with a stent system, allowing for a more streamlined and efficient repair of complex aortic aneurysms. Unlike traditional options that often require multiple surgeries or complex procedures, the Thoraflex Hybrid integrates the repair components into a single device. This innovative design potentially reduces surgery time and recovery periods, making it a promising advancement in the treatment of aortic conditions. Researchers are excited about its potential to improve patient outcomes with fewer complications and a quicker return to normal activities.

What evidence suggests that the Thoraflex Hybrid device and RelayPro NBS stent-graft are effective for aortic disease?

Research has shown that the Thoraflex Hybrid device, which participants in this trial may receive, effectively treats complex problems in the aortic arch, a part of the main artery. One study found that patients using this device had good results over five years. Designed to replace the entire aortic arch, the device has been successfully used in patients with challenging conditions.

Regarding the RelayPro NBS stent-graft, another treatment option in this trial, studies have demonstrated its safety and effectiveness for treating aortic bulges and related issues. Specifically, one study reported a 100% success rate, indicating the device functioned as planned during procedures. Both devices have strong records in treating aortic diseases. ^{1 3 5 6 7}

Who Is on the Research Team?

Martin Czerny

Principal Investigator

University of Freiburg

Joseph E Bavaria

Principal Investigator

Jefferson Health and Sidney Kimmel Medical College

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+

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200045B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The RelayPro consists of two types of implants, namely the proximal bare stent configuration and the non-bare stent (NBS) configuration. The RelayPro is a next ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0890509619300342

Prospective Multicenter Study of the Low-Profile Relay ... Mean vascular access diameter was 9.1 mm (6–13 mm); 7 patients (23%) had vascular access of 7 mm or less. Technical success was 100% (primary, 90%; assisted ...

3. veithsymposium.org veithsymposium.org/2024/abstracts/vei/729.pdf

Disclosures RelayPro Thoracic Stent-Graft System ... The primary endpoint is all-cause mortality at 30-days post-procedure. • The primary endpoint was compared to a Performance Goal (PG) of 25%.

4. terumoaortic.com terumoaortic.com/wp-content/uploads/2025/01/RelayPro-Annual-Clinical-Update.docx

RelayPro – Annual Clinical Update 2022 The study was designed to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with fusiform aneurysms and saccular ...

5. jtcvs.org jtcvs.org/article/S0022-5223(22)00101-5/fulltext

One-year results with a low-profile endograft in subjects ... The RelayPro device (Terumo Aortic) demonstrated 1-year safety and effectiveness for the treatment of descending thoracic aneurysms and PAUs: ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200045S002B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The RelayPro Stent- Graft System consists of two types of implants, namely the proximal bare stent configuration and the non-bare stent (NBS) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03207568

Study Details | NCT03207568 | RE-GENERATION: The ... The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic ...