Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms

NCT06834607 | Recruiting DMC FDA Device

• 2 other identifiers: Ref #: 040115G250012
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.

Conditions

Juxta Renal Abdominal Aortic Aneurysm Without Rupture; Complex Aortic Aneurysms; Aortic Aneurysm

Keywords

Physician Modified Endograft; PMEG; Complex aortic aneurysms; Juxta renal aortic aneurysm

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Safety of PMEG device will be measured by proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure.

  The Primary Safety Endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure. Major Adverse Events that will be recorded include the following: * All-cause mortality * Myocardial Infarction * Stroke * Renal Failure * Respiratory Failure * Paraplegia * Bowel Ischemia * Procedural Blood Loss (\> 1000cc)

  30 days

• Primary Effectiveness Endpoint: Will be measured by calculating the proportion of patients that achieve Treatment Success

  Effectiveness of the PMEG device will be measured by the calculating the proportion of subjects that achieve Treatment Success. Treatment Success is a will be assessed at 12 months and is define by a combination of following criteria to be met: * Technical Success (at the index procedure). * Freedom from Type I \& III endoleaks at 12 months * Freedom from stent graft migration at 12 months * Freedom from aortic aneurysm enlargement at 12 months * Freedom from aortic aneurysm rupture and conversion to open repair through 12 months Technical Success at the index procedure will be defined by: The physician was able to insert the delivery catheter and deliver the physician modified endovascular graft to the treatment site and preserve blood flow into the vessels intended to have blood flow preserved.

  12 months

Secondary Outcomes (2)

• Secondary Safety Endpoints: Will be assessed by measuring proportion of patients encountering any of the following adverse events

  Through 5 years

• Secondary Effectiveness Endpoints: Defined by proportion of patients experiencing the following events.

  Through 5 years

Study Arms (1)

Treatment arm

EXPERIMENTAL

Device: Physician Modified Aortic Endograft repair for complex aortic aneurysm

Interventions

Physician Modified Aortic Endograft repair for complex aortic aneurysm DEVICE

To assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years of age
• Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
• Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
• Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:
• An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
• Aneurysm with a history of growth \> 0.5 cm in 6 months
• Saccular aneurysm deemed at significant risk for rupture
• Symptomatic aneurysm
• Ruptured aneurysm
• Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.
• Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.
• Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.
• Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
• Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
• Patient has juxtarenal aortic neck angulation ≤ 60°

You may not qualify if:

• Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
• Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
• Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
• Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
• Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
• Patient has known allergy or intolerance to stainless steel, nitiol, or gold (gold-plated tungsten)
• Patient has a body habitus that would inhibit X-ray visualization of the aorta
• Patient has a limited life expectancy of less than 1 year
• Patient is currently participating in another investigational device or drug clinical trial
• Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
• Thrombus or excessive calcification within the neck of the aneurysm
• Branch vessel stenosis ≥ 80 %
• Patients treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.
• Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.

Sponsors & Collaborators

• Akhilesh Jain: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Akhilesh K Jain, MD

CONTACT

860-522-4158; akhilesh.jain@hhchealth.org

Vicky McLeod, BS

CONTACT

860-972-5799; Vicky.MacLeod@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Vascular Surgery, Harford Hospital

Model Details: Prospective, single center, nonrandomized, single arm study.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 19, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2032
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)