NCT05195905

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
39mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jun 2023Aug 2029

First Submitted

Initial submission to the registry

January 4, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

5.7 years

First QC Date

January 4, 2022

Last Update Submit

April 14, 2025

Conditions

Pararenal Aortic AneurysmThoracoabdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

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

    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

    Day 30

  • Number of subjects with treatment success

    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.

    Month 12

Secondary Outcomes (2)

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

    Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60

  • Number of subjects with treatment success and freedom from secondary intervention

    Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60

Study Arms (1)

Physician-modified endografts

EXPERIMENTAL

For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room.

Device: PMEG

Interventions

PMEGDEVICE

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.

Physician-modified endografts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

University of South Florida - South Tampa Campus

Tampa, Florida, 33606, United States

RECRUITING

Related Publications (10)

  • Dossabhoy SS, Simons JP, Flahive JM, Aiello FA, Sheth P, Arous EJ, Messina LM, Schanzer A. Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. J Vasc Surg. 2018 Jun;67(6):1673-1683. doi: 10.1016/j.jvs.2017.10.055. Epub 2017 Dec 8.

    PMID: 29224942BACKGROUND

  • Oderich GS, Ribeiro MS, Sandri GA, Tenorio ER, Hofer JM, Mendes BC, Chini J, Cha S. Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Jul;70(1):31-42.e7. doi: 10.1016/j.jvs.2018.09.063. Epub 2018 Dec 21.

    PMID: 30583902BACKGROUND

  • Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.

    PMID: 26792544BACKGROUND

  • Schanzer A, Simons JP, Flahive J, Durgin J, Aiello FA, Doucet D, Steppacher R, Messina LM. Outcomes of fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2017 Sep;66(3):687-694. doi: 10.1016/j.jvs.2016.12.111. Epub 2017 Mar 1.

    PMID: 28259577BACKGROUND

  • Oderich GS, Ribeiro M, Hofer J, Wigham J, Cha S, Chini J, Macedo TA, Gloviczki P. Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones. J Vasc Surg. 2017 May;65(5):1249-1259.e10. doi: 10.1016/j.jvs.2016.09.038. Epub 2016 Dec 13.

    PMID: 27986479BACKGROUND

  • Conrad MF, Crawford RS, Davison JK, Cambria RP. Thoracoabdominal aneurysm repair: a 20-year perspective. Ann Thorac Surg. 2007 Feb;83(2):S856-61; discussion S890-2. doi: 10.1016/j.athoracsur.2006.10.096.

    PMID: 17257941BACKGROUND

  • Coselli JS, Bozinovski J, LeMaire SA. Open surgical repair of 2286 thoracoabdominal aortic aneurysms. Ann Thorac Surg. 2007 Feb;83(2):S862-4; discussion S890-2. doi: 10.1016/j.athoracsur.2006.10.088.

    PMID: 17257942BACKGROUND

  • Schepens MA, Heijmen RH, Ranschaert W, Sonker U, Morshuis WJ. Thoracoabdominal aortic aneurysm repair: results of conventional open surgery. Eur J Vasc Endovasc Surg. 2009 Jun;37(6):640-5. doi: 10.1016/j.ejvs.2009.03.011. Epub 2009 Apr 11.

    PMID: 19362499BACKGROUND

  • Arnaoutakis DJ, Scali ST, Beck AW, Kubilis P, Huber TS, Martin AJ, Laquian L, Back M, Giles KA, Fatima J, Beaver TM, Upchurch GR Jr. Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 May;71(5):1503-1514. doi: 10.1016/j.jvs.2019.08.236. Epub 2019 Nov 11.

    PMID: 31727462BACKGROUND

  • Scali ST, Kim M, Kubilis P, Feezor RJ, Giles KA, Miller B, Fatima J, Huber TS, Berceli SA, Back M, Beck AW. Implementation of a bundled protocol significantly reduces risk of spinal cord ischemia after branched or fenestrated endovascular aortic repair. J Vasc Surg. 2018 Feb;67(2):409-423.e4. doi: 10.1016/j.jvs.2017.05.136. Epub 2017 Oct 7.

    PMID: 29017806BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, AbdominalAortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Konstantinos Arnaoutakis, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Montera

CONTACT

8138447948bmontera@usf.edu

Konstantinos Arnaoutakis, MD

CONTACT

arnaoutakis@usf.edu

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
Assistant Professor of Surgery

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 19, 2022

Study Start

June 6, 2023

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)