New Aortic Repair Device for Aortic Aneurysm

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to fix aortic aneurysms, which are dangerous bulges in the aorta, the large blood vessel that carries blood from the heart. The trial aims to determine if the device, called the Unitary Manifold or Visceral Manifold and Thoracic Bifurcation, is safe and effective, and it evaluates its long-term performance. Individuals with an aortic aneurysm that is large, rapidly growing, or symptomatic might be suitable candidates for this study. As an unphased trial, this study offers a chance to contribute to groundbreaking research that could enhance future treatments for aortic aneurysms.

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 prior data suggests that this new aortic repair device is safe for aortic aneurysm repair?

Research has shown that the Unitary Manifold device performed well in previous studies. It succeeds in surgeries and remains effective over time. One study found it effective even for patients with severe allergies to traditional contrast dyes, indicating good tolerance. Another review showed positive results for patients using this device at both 30 days and 1 year after surgery.

The Visceral Manifold and Thoracic Bifurcation device has received breakthrough status, indicating expected effectiveness and safety. Although specific safety details are not provided, this status suggests confidence in its safety. The device is designed to maintain blood flow during placement, which can help reduce procedural risks.

Overall, data suggests these devices are well-tolerated and have a good safety record for patients with aortic aneurysms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The TAAA Debranching Stent Graft System is unique because it introduces an innovative approach to treating aortic aneurysms using the Thoracic Bifurcation, Visceral Manifold, and Unitary Manifold devices. Unlike traditional open surgery or existing endovascular options, this system is designed to facilitate endovascular stenting while maintaining blood flow to the vital visceral vessels like the renal arteries, celiac artery, and superior mesenteric artery. This method is particularly exciting for patients who are not eligible for conventional treatments due to complex anatomy or other health issues, as it offers a minimally invasive alternative that can potentially expand treatment options for those with limited choices. Researchers are eager to see if this system can effectively address the challenges posed by these complex cases.

What evidence suggests that this device is effective for aortic aneurysm repair?

In this trial, participants will be assigned to one of two arms to evaluate the effectiveness of the Unitary Manifold and the Visceral Manifold with Thoracic Bifurcation for repairing aortic aneurysms. Research has shown that these devices yield promising results, with high success rates in both the surgery and patient recovery. The devices perform well during procedures and aid in better recovery. They have demonstrated good patency rates, meaning they remain open and functional over time. These devices allow blood to flow continuously while the aneurysm is being repaired, which is crucial for patient safety. Early study results suggest these devices are reliable options for patients with complex anatomy or other health issues that make traditional surgery risky. ^{1 6 7 8 9}

Who Is on the Research Team?

Patrick W Kelly, MD

Principal Investigator

Sanford Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03075748

Visceral Manifold Study for the Repair of TAAA | ... The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38552883/

Thoracoabdominal aneurysm repair using the Unitary ... The UM device demonstrated remarkable technical surgical success, treatment success, and device patency rates with very reasonable major ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0741521420305991

A novel physician-assembled endograft for the repair of ... In the present study, we reviewed the 30-day and 1-year clinical results of the use of the investigational unitary manifold (UM) stent graft system (Sanford ...

4. withpower.com withpower.com/trial/phase-aneurysm-1-2015-26ee7

New Aortic Repair Device for Aortic Aneurysm What data supports the effectiveness of the treatment Unitary Manifold, Visceral Manifold, and Thoracic Bifurcation for aortic aneurysm? Research shows that ...

5. annalsofvascularsurgery.com annalsofvascularsurgery.com/article/S0890-5096(23)00002-X/fulltext

Treatment of Thoracoabdominal Aortic Aneurysmal ... This study examines the use of 1 such novel approach in the treatment of aneurysmal degeneration after aortic dissection. Methods. Materials.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772687823000715

CO2 contrast-only thoracoabdominal aortic aneurysm ... We discuss a patient with a severe contrast allergy who underwent successful endovascular repair of a thoracoabdominal aortic aneurysm with the Unitary Device.

7. evtoday.com evtoday.com/articles/2021-mar/modern-complex-stent-graft-designs-a-closer-look

Modern Complex Stent Graft Designs: A Closer Look The 5-year results recently confirmed the safety and efficacy of the device for juxtarenal aortic aneurysms with minimum infrarenal sealing of 4 to 15 mm.10 The ...

8. yalemedicine.org yalemedicine.org/news/endovascular-surgery-thoracoabdominal-aortic-aneurysm

Endovascular Surgery for Aneurysms? A New Approach to ... Aortic aneurysm disease is the 12th leading cause of death in the U.S. An aneurysm can develop anywhere along the aorta—the body's major blood ...

9. jvascsurg.org jvascsurg.org/article/S0741-5214(20)30599-1/fulltext

A novel physician-assembled endograft for the repair of ... In the present study, we reviewed the 30-day and 1-year clinical results of the use of the investigational unitary manifold (UM) stent graft ...