New Aortic Repair Device for Aortic Aneurysm

Recruiting at 1 trial location

Overseen By Katie Pohlson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sanford Health

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Pregnancy, Ruptured aneurysm, Dissection, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing special devices to fix a damaged artery in the chest and abdomen. It focuses on patients with a specific type of artery damage. The devices work by providing internal support to the weakened artery, offering a more individualized treatment option.

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 trial coordinators or your doctor.

What data supports the effectiveness of the treatment Unitary Manifold, Visceral Manifold, and Thoracic Bifurcation for aortic aneurysm?

Research shows that modular and branched devices, similar to the new treatment, have been effective in treating complex aortic aneurysms, reducing complications and expanding treatment options for patients with challenging conditions. ^{1 2 3 4 5}

Is the new aortic repair device safe for humans?

Research on similar devices, like the INCRAFT endograft and RELAY NBS PLUS stent-graft, shows they have been tested for safety in humans with aortic aneurysms. These studies generally focus on the safety and performance of these devices in treating complex aortic conditions. ^{3 6 7 8 9}

How is the New Aortic Repair Device treatment different from other treatments for aortic aneurysms?

The New Aortic Repair Device is unique because it uses a modular and branched endovascular stent-graft, which is designed to treat complex aortic aneurysms involving the visceral arteries. This approach allows for a more customized fit to the patient's anatomy, potentially improving outcomes compared to traditional surgical methods. ^{1 2 3 4 10}

Research Team

Patrick W Kelly, MD

Principal Investigator

Sanford Health

Eligibility Criteria

Adults with thoracoabdominal aortic aneurysms that are large, growing, or at risk of rupture can join this trial. They must have specific vessel sizes and access points for the devices used in the study. Those with recent major procedures, infections, certain connective tissue disorders, allergies to device materials, kidney issues (high creatinine levels), or poor overall health cannot participate.

Inclusion Criteria

You are expected to live for more than 1 year.

My aorta fits the size and condition requirements for a specific stent graft.

I have a large aneurysm causing symptoms.

Exclusion Criteria

Urgent or emergent presentation

Patient is pregnant or breastfeeding

I have major issues with two of my body systems like heart, lungs, kidneys, liver, or muscles.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular stenting using the thoracic bifurcation and visceral manifold or unitary device to repair thoracoabdominal aortic aneurysms

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including freedom from major adverse events and treatment success

5 years

Regular visits at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Treatment Details

Interventions

• Unitary Manifold
• Visceral Manifold and Thoracic Bifurcation

Trial Overview The study is testing two different devices: Visceral Manifold and Thoracic Bifurcation versus Unitary Manifold for repairing aortic aneurysms. It aims to evaluate their safety and effectiveness over time by monitoring patients who receive these treatments.

Participant Groups

Group I: Primary Study Arm Experimental Treatment 2 Interventions

The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcation and the Visceral Manifold and the Unitary Manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.

Group II: Expanded Selection Arm Experimental Treatment 2 Interventions

The expanded selection arm is for subjects not eligible for open repair or other endovascular options due to comorbidities or anatomical limitations and do not meet inclusion in the primary study arm. The Thoracic Bifurcation and the Visceral Manifold as well as the Unitary Manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.

Who Is Running the Clinical Trial?

Sanford Health

Lead Sponsor

Trials

53

Recruited

2,067,000+

Dakota Vascular

Collaborator

Trials

2

Recruited

350+

References

1. United States pubmed.ncbi.nlm.nih.gov

Modular bifurcation endoprosthesis for treatment of abdominal aortic aneurysms. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Hemodynamic numerical simulation of aortic arch modular inner branched stent-graft in eight early patients from the first-in-human case series. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Branched Endograft Partial Deployment to Save Space for Vessel Cannulation When Treating Aneurysms with Narrow Aortic Lumen. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Results of endovascular repair of TAAA in the first 50 patients]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Fenestrated and branched endografts. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Editor's Choice - Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED). [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

Clinical experience with the RELAY NBS PLUS stent-graft for aortic arch pathology. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the INNOVATION trial. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Repair of recurrent visceral aortic patch aneurysm after thoracoabdominal aortic aneurysm repair with a branched endovascular stent graft. [2016]