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?

This trial evaluates new, custom-made stent grafts for treating complex aortic aneurysms, which are dangerous bulges in the main artery. It targets individuals who cannot use standard endografts due to unique anatomy or health risks. The trial also includes participants with connective tissue diseases such as Marfan and Ehlers-Danlos syndromes. Those advised to repair their aneurysm soon but unable to undergo open surgery may be suitable candidates. As an unphased trial, it provides a unique opportunity for patients to access innovative treatments tailored to their specific needs.

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 prior data suggests that these custom-made devices are safe for treating complex aortic aneurysms?

Research has shown that custom-made stent grafts, designed with small openings or branches, are generally safe for treating complex aortic aneurysms. In one study, patients, including those with previous unsuccessful treatments, responded well to these devices. The research found no major safety issues. Few unexpected problems occurred, indicating that most patients did not face serious issues with the treatment. Another study highlighted that these custom devices deliver excellent results for patients with complex aneurysms. This suggests the treatment is reliable and effective for those who need it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about custom-made endografts for aortic aneurysms because they offer a personalized approach to treating complex cases that standard stent grafts might not address effectively. Unlike traditional stent grafts, which are one-size-fits-all, these custom-made devices are tailored to fit the unique anatomy of each patient's aorta, potentially improving outcomes and reducing complications. Additionally, the use of fenestrated or branched designs allows for better blood flow to vital arteries, which can be a limitation with conventional treatments. This innovative approach could lead to safer and more effective repairs of complex aortic aneurysms.

What evidence suggests that custom-made endografts are effective for complex aortic aneurysms?

Research has shown that specially designed stent grafts effectively treat complex aortic aneurysms. In this trial, participants will undergo endovascular repair using custom-made fenestrated or branched stent grafts, tailored to fit each patient's body, aiding in the successful repair of the aneurysm. Studies have found that doctor-modified grafts, with small openings added, can effectively treat aneurysms and improve patient health. This method is especially helpful for patients unable to use standard grafts or at high risk for traditional surgery. Overall, these custom devices hold promise for safely managing complex aneurysms. ^{2 3 4 5 6}

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

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]

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]

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]

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]

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]

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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.068587

Multicenter Study on Physician-Modified Endografts for ... Currently, the gold-standard for CAAA are fenestrated and branched custom-made devices (CMD), showing excellent results. However, CMDs are not ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11278265/

Physician-Modified Endografts for Repair of Complex ... Physicians have proposed modifying standard endografts by manually creating graft fenestrations. This allows for effective aneurysm exclusion and satisfactory ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0741521423015902

Comparative outcomes of physician-modified fenestrated ... Physician-modified fenestrated/branched EVAR is safe and effective treatment option for patients with complex aneurysms who have a prior failed EVAR in place.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02050113?cond=marfan&page=5&rank=49

Complex Aortic Aneurysm Repair Using Physician ... 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 ...

5. annalsofvascularsurgery.com annalsofvascularsurgery.com/article/S0890-5096(25)00127-X/fulltext

Physician-Modified Endografts Achieve Similar Patient ... The purpose of this study was to conduct a real-world comparison of visceral stent branch related outcomes and patient survival in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7126501/

Intraoperative adverse events and early outcomes of custom ... The aim of this study was to describe in-hospital outcomes of custom-made fenestrated stent grafts (CMSGs) and PMSGs for the treatment of CAAAs ...