Custom-Made Endograft for Aortic Aneurysm

(CARPE-CMD Trial)

Overseen By Andres Schanzer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andres Schanzer

Disqualifiers: Blood product objection, Allergies, Unstable angina, Active malignancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6-8 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

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.

Is the custom-made endograft for aortic aneurysm generally safe for humans?

Studies show that custom-made endografts, including fenestrated and branched stent grafts, have been used successfully with high technical success and low rates of complications. These devices are designed to fit individual patients and have shown promising safety results in treating complex aortic aneurysms, with low morbidity (complications) and mortality (death) rates. ^{1 2 3 4 5}

How is the Custom Made Endograft treatment for aortic aneurysm different from other treatments?

The Custom Made Endograft treatment for aortic aneurysm is unique because it is specifically tailored to fit the patient's anatomy, allowing it to address complex aneurysms that standard treatments cannot. Unlike off-the-shelf options, these custom-made grafts incorporate fenestrations (small openings) and branches to accommodate the patient's specific vascular structure, although they require a 6- to 8-week customization period. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Custom Made Endograft for Aortic Aneurysm?

Research shows that fenestrated and branched stent grafts, which are similar to custom-made endografts, have been used successfully to treat complex aortic aneurysms with high success rates and low complications. These treatments help maintain blood flow to important arteries and have shown good long-term results in experienced centers. ^{3 4 6 7 10}

Who Is on the Research Team?

Andres Schanzer, MD

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

Adults with complex aortic aneurysms unsuitable for standard endovascular repair, at high risk for open surgery, or with specific connective tissue disorders like Marfan, Ehlers-Danlos, or Loeys-Dietz syndromes. Participants must not be pregnant/breastfeeding and able to follow up for five years.

Inclusion Criteria

Not pregnant or breastfeeding

Willing and able to provide informed consent prior to enrollment

I need immediate treatment and cannot wait for standard devices.

Exclusion Criteria

The length of my neck's upper part is 25 mm or less.

You are allergic to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol.

You are not expected to live more than two years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Endovascular repair of complex aortic aneurysms using custom made devices, Zenith t-Branch devices, or physician modified endografts

6-8 weeks

1 visit (in-person) for procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of treatment success and incidence of major adverse events

12 months

Regular follow-up visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Custom Made Fenestrated or Branched Stent Graft

Trial Overview The trial is testing custom-made stent grafts and modified FDA-approved devices on patients who can't use standard grafts due to their unique anatomy or those who cannot wait for traditional device manufacturing because of the severity of their condition.

How Is the Trial Designed?

Group I: Endovascular repair Experimental Treatment 1 Intervention

Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft. custom made device or arch branch device.

Custom Made Fenestrated or Branched Stent Graft is already approved in United States, European Union for the following indications:

Approved in United States as Zenith t-Branch for:

• Thoracoabdominal aortic aneurysms
• Complex abdominal aneurysms
• Aortoiliac aneurysms
• Aortic arch aneurysms

Approved in European Union as Zenith t-Branch for:

• Thoracoabdominal aortic aneurysms

Who Is Running the Clinical Trial?

Andres Schanzer

Lead Sponsor

Trials

1

Recruited

600+

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Published Research Related to This Trial

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]

Endovascular repair using fenestrated and branched stent grafts for pararenal and thoracoabdominal aortic aneurysms has shown high technical success rates and low complications, with an 89% freedom from branch-related events over 5 years.

Off-the-shelf stent grafts offer advantages like reduced treatment delays and standardized procedures, but they have anatomical limitations that may restrict their use in some patients, highlighting the need for long-term durability studies compared to customized grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-the-shelf fenestrated and branched stent graft designs for abdominal aortic aneurysm repair. Mendes, BC., Rathore, A., Ribeiro, MS., et al.[2017]

Surgeon-modified fenestrated-branched stent grafts (sm-FBSGs) were successfully used in 12 high-risk patients with symptomatic or ruptured complex aortic aneurysms, demonstrating a 100% implantation success rate and no cases of paraplegia or intraoperative death.

Despite the high-risk nature of the patients, with significant comorbidities, the procedure resulted in manageable morbidity and a mean postoperative hospital stay of 8 days, indicating that sm-FBSGs can be a safe and effective alternative for urgent treatment in patients who cannot wait for custom devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgeon-modified fenestrated-branched stent grafts to treat emergently ruptured and symptomatic complex aortic aneurysms in high-risk patients. Ricotta, JJ., Tsilimparis, N.[2012]

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]

Fenestrated endovascular aneurysm repair (FEVAR) offers a standardized treatment option for patients with abdominal aortic aneurysms who may not qualify for traditional endovascular repair, thereby expanding the patient population that can benefit from this intervention.

The use of parallel, branched, and fenestrated grafts improves the quality of the graft landing zone by preserving healthy aortic tissue near critical arteries, which is crucial for the success of the repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated Endovascular Abdominal Aortic Aneurysm Repair. Pena, CS., Schiro, BJ., Benenati, JF.[2018]

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]

In a study of 82 patients undergoing fenestrated endovascular aneurysm repair, no significant differences in overall survival or major complications were found between physician-modified endografts (PMEG) and company-manufactured devices (CMD), suggesting both are safe options for complex aortic aneurysm repair.

However, PMEGs were associated with longer operative times, increased fluoroscopy time, and a higher 1-year reintervention rate (37% for PMEG vs. 13% for CMD), indicating that while both methods are viable, PMEGs may require more postoperative management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. Dossabhoy, SS., Simons, JP., Flahive, JM., et al.[2018]

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]

The Cook Zenith® and Vascutek Fenestrated Anaconda™ endografts have shown good clinical outcomes for treating complex aortic aneurysms, with perioperative mortality rates between 4.1% and 6.7% and a reintervention rate of less than 10% at one year.

Custom-made endografts like the Cook Zenith® allow for tailored treatment of complex aneurysms, while off-the-shelf options were developed due to the long production time of custom grafts, although some off-the-shelf options have been withdrawn due to high reintervention rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fenestrated Endografts for Complex Abdominal Aortic Aneurysm Repair. de Niet, A., Reijnen, MM., Tielliu, IF., et al.[2018]

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]

Citations

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

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

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

Off-the-shelf fenestrated and branched stent graft designs for abdominal aortic aneurysm repair. [2017]

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

Surgeon-modified fenestrated-branched stent grafts to treat emergently ruptured and symptomatic complex aortic aneurysms in high-risk patients. [2012]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Fenestrated Endovascular Abdominal Aortic Aneurysm Repair. [2018]

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

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

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

Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. [2018]

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

Fenestrated and branched stent grafts. [2016]

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

Fenestrated Endografts for Complex Abdominal Aortic Aneurysm Repair. [2018]

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]