Modified Stent Grafts for Aortic Aneurysm

Overseen By Jessica Schneider

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Life expectancy < 2 years, Others

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

Compensation: Varies

Number of Visits: 30

Duration: 12 months

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 Modified Stent Grafts for Aortic Aneurysm?

Research shows that fenestrated and branched stent grafts, which are similar to the modified stent grafts, have been effective in treating complex aortic aneurysms by maintaining blood flow to important arteries and providing a less invasive alternative to open surgery. These grafts have shown good results in experienced centers, with high success rates in keeping the targeted arteries open. ^{1 2 3 4 5}

Is the use of modified stent grafts for aortic aneurysm generally safe in humans?

Studies show that fenestrated and branched stent grafts, used for complex aortic aneurysms, have been refined over the years and are generally safe with good outcomes in experienced centers. However, there can be intraoperative adverse events, but early experiences have been encouraging, and short-term results compare favorably with open surgery. ^{1 3 6 7 8}

How is the treatment of modified stent grafts for aortic aneurysm different from other treatments?

Modified stent grafts for aortic aneurysms are unique because they use customized fenestrations (small openings) to maintain blood flow to vital side branches like the renal arteries, allowing for a completely endovascular (inside the blood vessel) approach to treat complex aneurysms that are not suitable for traditional surgery. ^{1 2 3 9 10}

What is the purpose of this trial?

The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and/or branches.

Research Team

Bernardo Mendes, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients with specific types of aortic aneurysms, including juxtarenal, pararenal, and thoracoabdominal. Participants should require endovascular treatment but the exact eligibility criteria are not provided in the information given.

Inclusion Criteria

I am considered high risk for standard surgery.

I have had previous surgeries or treatments in my abdomen or pelvis, or a history of severe abdominal infections.

I am over 75 or have serious health issues like heart or lung disease, kidney problems, or a high ASA score.

Exclusion Criteria

My blood vessels are not suitable for certain types of stent graft surgery.

I haven't had surgery or an interventional procedure in the last 30 days.

I don't have allergies to specific materials, severe reactions to contrast dye, bleeding disorders, fungal aneurysms, ongoing infections, certain connective tissue diseases, or a body shape that limits X-ray use.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular treatment of aortic aneurysms using physician-modified stent grafts

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at 30 days, 6 months, and annually up to 5 years

Treatment Details

Interventions

• Physician-Modified Fenestrated and Branched Stent Grafts

Trial Overview The study is testing the safety and effectiveness of modified stent grafts (Cook Alpha TX2 Stent Graft, Cook Zenith TX2, Cook Zenith Fenestrated) in treating complex aortic aneurysms that may involve iliac arteries.

Participant Groups

Group I: Subjects with urgent or emergent aneurysms Experimental Treatment 1 Intervention

Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Group II: Subjects with thoracoabdominal aortic aneurysms Experimental Treatment 1 Intervention

Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Group III: Subjects with short neck infrarenal, juxtarenal, suprarenal and extent IV TAA Experimental Treatment 1 Intervention

Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Fenestrated and branched stent grafts have been developed to treat abdominal aortic aneurysms in patients who are not suitable for traditional endovascular repair due to unfavorable anatomy, allowing for a completely endovascular approach.

These advanced stent grafts have shown promising short-term results that are comparable to open surgery, providing a viable option for patients with complex aneurysms and limited surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated and branched stent grafts. Ricotta, JJ., Oderich, GS.[2016]

Fenestrated stent-grafts are effective for treating short-necked aneurysms, allowing for the preservation of important side branches like renal arteries, with excellent patency rates reported in experienced centers.

The report summarizes a 5-year experience with these grafts, highlighting their technical principles and the feasibility of using either covered stents or fully branched grafts, each with its own advantages and limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated and branched stent-grafting: a 5-years experience. Verhoeven, EL., Tielliu, IF., Muhs, BE., et al.[2019]

Approximately 40% of patients with infrarenal aortic aneurysms face limitations in endovascular therapy due to anatomical constraints, highlighting the need for more adaptable treatment options.

Modified stent grafts with reinforced fenestrations or side branches may provide a promising solution for high-risk patients requiring urgent treatment for complex aneurysms, potentially allowing for immediate intervention in cases of impending or contained ruptures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urgent endovascular treatment of symptomatic or contained ruptured aneurysms with modified stent grafts. Oderich, GS., Farber, MA., Sanchez, LA.[2016]

In a study of 113 patients undergoing fenestrated and branched stent grafting for complex aortic diseases, intraoperative adverse events (IOAEs) occurred in 30.1% of patients, leading to significant complications in many cases.

Patients who experienced IOAEs had a higher rate of death or moderate to severe complications compared to those without IOAEs, highlighting the need for careful monitoring during these complex procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of intraoperative adverse events during branched and fenestrated aortic stent grafting on postoperative outcome. Cochennec, F., Kobeiter, H., Gohel, MS., et al.[2021]

The study reviewed over 100 cases of branched and fenestrated stent-graft repairs for complex aortic aneurysms, highlighting the technical challenges and complications associated with this endovascular approach, such as stent-graft dislocation and vessel occlusion.

Based on their experience, the authors propose several modifications to the technique that could enhance the outcomes of these complex endovascular repairs, aiming to reduce the need for secondary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pararenal and thoracoabdominal aortic aneurysm repair with fenestrated and branched endografts: lessons learned and future directions. Austermann, M., Donas, KP., Panuccio, G., et al.[2016]

References

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

Fenestrated and branched stent grafts. [2016]

2. Italy pubmed.ncbi.nlm.nih.gov

Fenestrated and branched endovascular techniques for thoraco-abdominal aneurysm repair. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Fenestrated and branched stent-grafting: a 5-years experience. [2019]

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

Outcome of Surgeon-Modified Fenestrated/Branched Stent-Grafts for Symptomatic Complex Aortic Pathologies or Contained Rupture. [2019]

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

Urgent endovascular treatment of symptomatic or contained ruptured aneurysms with modified stent grafts. [2016]

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

Systematic Review of Off-the-Shelf or Physician-Modified Fenestrated and Branched Endografts. [2018]

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

Impact of intraoperative adverse events during branched and fenestrated aortic stent grafting on postoperative outcome. [2021]

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

Increasing Role of Fenestrated and Branched Endoluminal Techniques in the Thoracoabdominal Segment Including Supra- and Pararenal AAA. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Diameter-reducing wire to facilitate deployment of a modified Zenith fenestrated stent graft. [2016]

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

Pararenal and thoracoabdominal aortic aneurysm repair with fenestrated and branched endografts: lessons learned and future directions. [2016]