Endovascular Grafts for Aortic Disorders

Overseen By Ellen R Burkett, MSHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chandler Long, MD

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Pregnancy, Infection, Obesity, others

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

Compensation: Varies

Number of Visits: 8

Duration: During hospitalization

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special kind of endovascular graft, the Physician Modified Endovascular Graft, which surgeons customize to fit a patient's unique anatomy for treating aortic disorders. The goal is to determine if these modified grafts can be used safely and effectively. This trial may suit individuals with serious aortic issues, such as large or fast-growing aneurysms, who face high risks with traditional surgery. Participants must attend regular follow-up visits for five years to monitor the treatment's success. As an unphased trial, it provides patients with a unique opportunity to access innovative treatment options tailored to their specific needs.

Will I have to stop taking my current medications?

The trial information does not specify if 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 physician modified endovascular grafts are safe for treating aortic disorders?

Research has shown that physician-modified endovascular grafts (PMEG) are generally safe for treating aortic problems. One study reported no deaths within the first 30 days or even after one year for a specific type of graft repair, indicating a strong initial safety record. However, another study found that about 7.6% of patients experienced aorta-related deaths over approximately four years.

Overall, the safety results suggest that while some risks exist, many patients respond well to this treatment. Patients receiving these grafts often have other health issues that can affect their outcomes. It is important to discuss potential risks and benefits with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Physician Modified Endovascular Graft is unique because it allows surgeons to customize a commercially available graft to fit the specific anatomy of each patient with aortic disorders. Traditional treatments often rely on pre-manufactured grafts that may not perfectly match every patient's anatomy, potentially leading to less optimal outcomes. This tailored approach aims to improve the precision and effectiveness of the repair, potentially reducing complications and enhancing recovery. Researchers are excited about this treatment because it represents a personalized solution in vascular surgery, which could lead to better patient-specific outcomes.

What evidence suggests that physician modified endovascular grafts are effective for aortic disorders?

Research has shown that custom-made endovascular grafts, known as PMEG, are highly effective in treating aortic problems. One study found that the procedure was completed as planned in 93.7% of cases, and the graft functioned well without major issues in 82.6% of cases. Another study reported that after five years, survival rates ranged from 41% to 69%, depending on the patient's other health conditions. At three years, 97.2% of patients remained alive, with most not experiencing issues like graft instability or needing additional surgeries. These findings suggest PMEG is a promising option for those requiring personalized treatment for aortic conditions. Participants in this trial will receive a Physician Modified Endovascular Graft tailored to their anatomy for surgery. ^{1 5 6 7 8}

Who Is on the Research Team?

Chandler Long, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults with thoracic aortic disease who've had previous surgeries or have heart, lung, or blood vessel conditions. They should have an aortic aneurysm of certain size or growth rate, specific artery sizes and angles suitable for the graft, and be able to undergo follow-up visits for 5 years.

Inclusion Criteria

I am part of the main study group.

a. Anatomic Criteria (Previous abdominal surgery; Previous thoracotomy; Previous aortic surgery) b. Physiologic Criteria (ASA Category III or higher; Age \>70 years; Previous myocardial infarction, coronary artery disease, or coronary artery stent; Coronary stress test with a reversible perfusion defect; Congestive heart failure (CHF); Chronic obstructive pulmonary disease (COPD))

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery with a physician-modified endovascular graft tailored to their anatomy

During hospitalization

1 visit (in-person)

Initial Follow-up

Participants are monitored for major adverse events and technical success

30 days

1 visit (in-person)

Extended Follow-up

Participants are monitored for treatment success and safety outcomes

5 years

Visits at 6 months, 12 months, and annually

What Are the Treatments Tested in This Trial?

Interventions

• Physician Modified Endovascular Graft

Trial Overview

Researchers are testing if customized stent-grafts can safely treat aortic disorders. Surgeons will tailor a commercial graft to fit each patient's anatomy during surgery. Participants' health will be monitored through regular clinic visits involving imaging and blood tests over five years.

How Is the Trial Designed?

Group I: Physician Modified Endovascular Graft Experimental Treatment 1 Intervention

The participant's surgeon will modify a commercially available graft tailored to their anatomy for their surgery.

Who Is Running the Clinical Trial?

Chandler Long, MD

Lead Sponsor

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38920026/

Long-Term Results of Physician-Modified Endografts for ...

Technical success was 93.7%, and overall treatment success was 82.6%. Conclusions: PMEG can be performed with low rates of long-term morbidity ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0890509625007204

Benchmark Results for Physician Modified Endografts

At 5 years, overall survival for PMEG patients ranges from 41%-69%, likely reflecting the underlying comorbidity burden in the high surgical ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.068587

Multicenter Study on Physician-Modified Endografts for ...

Efficacy outcomes included technical success and safety ruptured complex abdominal and thoracoabdominal aortic aneurysms.

4.

jtcvstechniques.org

jtcvstechniques.org/article/S2666-2507(23)00013-5/fulltext

Midterm outcomes of physician-modified endovascular ...

At 3 years, survival, freedom from any branch instability, and freedom from endoleak and reintervention were 97.2%, 97.3%, 86.9%, and 85.8% in the PD-TAAAs ...

5.

jvsvi.org

jvsvi.org/article/S2949-9127(25)00012-1/fulltext

Aortic remodeling and survival for chronic post dissection ...

Perioperative outcomes. Technical success was achieved in 96.8% of cases (60/62). Major adverse events occurred in five patients (6.9%), ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11189729/

Early Financial Outcomes of Physician Modified Endograft ...

There were no deaths in thirty days or one year for ZFEN repair. There was no significant difference in thirty-day and one-year mortality ...

7.

jvascsurg.org

jvascsurg.org/article/S0741-5214(22)02321-7/fulltext

Five-year outcomes of physician-modified endografts for ...

After a mean follow-up of 49 ± 38 months, there were 12 aortic-related deaths (7.6%), including nine early deaths (5.7%) from perioperative ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04746677

Safety and Efficacy of Endovascular Repair of Complex ...

The safety outcomes include perioperative mortality (defined as death <30 days postoperative or during the index hospitalization) and major adverse events, ...