PMEGs for Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Anticoagulants, Contrast media

Disqualifiers: Pregnancy, Ruptured aneurysm, Connective tissue disorders, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.

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 data supports the effectiveness of the treatment Physician-modified Endovascular Graft (PMEG) for Aortic Aneurysm?

Research shows that PMEGs are effective for treating complex aortic aneurysms, especially in patients who cannot undergo open surgery. Studies indicate that PMEGs provide a survival benefit over other techniques like parallel grafting for certain types of aortic aneurysms. ^{1 2 3 4 5}

Is the physician-modified endovascular graft (PMEG) safe for humans?

Research shows that PMEGs have been used safely in patients with complex aortic aneurysms who are not suitable for open surgery, indicating they are generally safe for human use. ^{1 2 3 5 6}

How is the treatment PMEG different from other treatments for aortic aneurysms?

The Physician-modified Endovascular Graft (PMEG) is unique because it is customized by doctors to fit the specific needs of patients who cannot undergo open surgery for aortic aneurysms. This approach allows for a more personalized treatment compared to standard off-the-shelf devices. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 21 with complex aortic problems like certain aneurysms or dissections, who are at high risk from traditional surgery. They should have specific measurements in their non-aneurysmal aorta and be able to undergo endovascular repair. Pregnant women, those with allergies to device materials, connective tissue disorders, or conditions preventing informed consent are excluded.

Inclusion Criteria

The part of my aorta closest to my heart is the right size and doesn't have an aneurysm.

My doctor expects me to live for at least 2 more years.

I have a type B aortic dissection, had surgery for type A, or have an aortic intramural hematoma.

Exclusion Criteria

Known sensitivities or allergies to the materials of construction of the devices

Subject is pregnant or breastfeeding

Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants are evaluated preoperatively to assess their suitability for the procedure

1 week

1 visit (in-person)

Treatment

Participants undergo endovascular repair with physician-modified endovascular grafts (PMEGs)

During hospitalization

Procedure and hospitalization

Postoperative Monitoring

Participants are monitored for perioperative mortality and major adverse events

Up to 30 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including technical success, endoleak rate, and target vessel patency

5 years

1-month, 6-months, 1-year, and annually for 5 years

Treatment Details

Interventions

• Physician-modified Endovascular Graft (PMEG) (Endovascular Graft)

Trial Overview The study tests the safety and effectiveness of custom-tailored grafts (PMEGs) used in minimally invasive procedures for repairing complex aortic pathologies. Participants will be grouped based on their specific aortic condition: abdominal aneurysm, thoracoabdominal aneurysm, or dissection.

Participant Groups

Group I: Type B aortic dissection Experimental Treatment 1 Intervention

Includes all Type B dissections

Group II: Thoracoabdominal aortic aneurysm (TAAA) Experimental Treatment 1 Intervention

Includes Type I, Type II, and Type III TAAA

Group III: Expanded Selection Arm Experimental Treatment 1 Intervention

Includes high risk subjects who do not meet inclusion criteria for Arms !-3

Group IV: Complex abdominal aortic aneurysm (AAA) Experimental Treatment 1 Intervention

Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm

Physician-modified Endovascular Graft (PMEG) is already approved in United States for the following indications:

🇺🇸 Approved in United States as PMEG for:

• Complex abdominal aortic aneurysm (AAA)
• Thoracoabdominal aortic aneurysm
• Aortic dissection

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Beth Israel Deaconess Medical Center Boston, MA

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center Lead Sponsor

References

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

Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. [2022] To determine if a physician-modified endovascular graft (PMEG) is a safe and effective method of treating juxtarenal aortic aneurysms in patients considered to be unsuitable for open surgical repair.

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

Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. [2013] To determine whether a physician-modified endovascular graft (PMEG) is a safe and effective method for treating patients with juxtarenal aortic aneurysms who are deemed unsuitable for open repair.

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

Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms. [2017] The objective of this study was to report midterm results of an ongoing physician-sponsored investigational device exemption pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for treatment of patients with juxtarenal aortic aneurysms who are deemed unfit for open repair.

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

Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies. [2022] To describe the use of physician-modified endograft (PMEG) with the exclusive use of inner branches or in combination with fenestrations for the urgent treatment of complex aortic aneurysms.

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

Physician-modified endografts are associated with a survival benefit over parallel grafting in thoracoabdominal aneurysms. [2022] Physician-modified endografts (PMEG) and parallel grafting (PG) are important techniques for endovascular repair of complex aortic aneurysms using off-the-shelf devices. However, there are few data regarding the relative efficacy and outcomes of these techniques in thoracoabdominal extent aneurysms. This study sought to compare the outcomes of PG and PMEG across different extents of thoracoabdominal aneurysms (TAAAs) for which they can be used.

6. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of physician-modified endografts for the treatment of thoraco-abdominal and pararenal aortic pathologies at a single institution. [2022] This study aimed to describe the outcomes of high-risk patients with symptomatic or impending ruptured pararenal aneurysm and thoraco-abdominal aortic aneurysm with comorbidities unsuitable for conventional open surgery, using physician-modified endografts (PMEGs).