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NCT Number: NCT05195905

PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.

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Key information

Conditions

Pararenal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Diseases Cardiovascular Diseases Thoracoabdominal Aortic Aneurysm Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital, Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Male or female, aged ≥18 years
  • Expected survival beyond 1 year following successful aneurysm repair
  • Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length
  • Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection
  • Adequate proximal zone of fixation
  • Adequate distal zone of fixation
  • No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
  • Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary

Exclusion criteria

  • Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
  • Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
  • Proximal landing within zone 0 or 1
  • Inability to maintain at least one patent hypogastric artery
  • Freely ruptured aneurysm with hemodynamic instability
  • Non-ambulatory status
  • Severe CHF
  • Baseline eGFR < 30ml/min, unless currently on or to be initiating dialysis
  • Unstable angina
  • Stroke or MI within 3 months of planned treatment date
  • Active systemic infection and/or mycotic aneurysm
  • Uncorrectable coagulopathy or other bleeding diathesis
  • Known allergy to device material or contrast material that cannot be adequately pre-medicated
  • Body habitus that would preclude adequate fluoroscopic visualization of aorta
  • Pregnancy or lactation (confirmed per standard of care surgical practice)
  • Major, unrelated surgical procedure planned ≤30 days from endovascular repair
  • Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial
  • Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study
  • Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
  • Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution

Treatment and study plan

PMEG

Device

All devices that will be modified in this study protocol are commercially available in the United States. The commercially available endografts will be used to construct a fenestrated/branched device for this intervention.

Primary outcomes

  1. Number of subjects with 30-day major adverse events from primary procedure

    Time frame: Day 30

    Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation >72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc

  2. Number of subjects with treatment success

    Time frame: Month 12

    Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality.

Secondary outcomes

  1. Number of subjects with mortality, major adverse events, spinal cord ischemia

    Time frame: Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60

    Mortality includes all-cause mortality. Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation >72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc. Spinal cord ischemia data will include all incidence and degree of spinal cord ischemia.

  2. Number of subjects with treatment success and freedom from secondary intervention

    Time frame: Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60

    Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality. Freedom from secondary interventions includes interventions to treat malperfusion, rupture, aneurysm formation, aortic expansion, endoleak, device stenosis/occlusion, or access site complication.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Montera

CONTACT

[email protected]

8138447948

Konstantinos Arnaoutakis, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Konstantinos Dean Arnaoutakis, MD

Other

Registry information

Official study title

Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jan 19, 2022
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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