Pararenal Aortic AneurysmNCT05195905
PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
A study testing PMEG in people with Pararenal Aortic Aneurysm and Thoracoabdominal Aortic Aneurysm, run by Konstantinos Arnaoutakis, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
- What is being tested?
- PMEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to Feb 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Konstantinos Dean Arnaoutakis, MD contact
United States1 site, 1 recruiting
- Recruiting
Orlando Health Wiregrass Ranch Hospital
Wesley Chapel, Florida, 33543
TIna Henderson, 727-893-6392, tina.henderson@orlandohealth.com
Konstantinos Arnaoutakis, MD
About this study
Official title: Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts
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.
- Being tested
- PMEG
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PMEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Month 12
Secondary outcomes (2)
Number of subjects with mortality, major adverse events, spinal cord ischemia
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.
Measured: 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
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.
Measured: Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start6 Jun 2023
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pararenal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konstantinos Arnaoutakis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Orlando Health, Inc.
- Responsible party
- Sponsor-investigator, Konstantinos Arnaoutakis, MD, Orlando Health, Inc.
- Investigators
- Konstantinos Dean Arnaoutakis, MD, Principal investigator, Orlando Health - Florida Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195905
- Sponsor's protocol ID
- 2419542-1
- Status last verified
- Oct 2026
- First submitted
- 4 Jan 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29224942Oderich 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.
PubMed 30583902Eagleton 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.
PubMed 26792544Schanzer 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.
PubMed 28259577Oderich 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.
PubMed 27986479Conrad 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.
PubMed 17257941Coselli 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.
PubMed 17257942Schepens 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.
PubMed 19362499Arnaoutakis 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.
PubMed 31727462Scali 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.
PubMed 29017806Nguyen T, Gittinger M, Gryzbowski C, Patel S, Asirwatham M, Grundy S, Zwiebel B, Shames M, Arnaoutakis DJ. One-hundred Consecutive Physician-Modified Fenestrated Endovascular Aneurysm Repair of Pararenal and Thoracoabdominal Aortic Aneurysms Using the Terumo TREO Stent Graft. Ann Vasc Surg. 2024 Sep;106:369-376. doi: 10.1016/j.avsg.2024.04.009. Epub 2024 May 31.
PubMed 38823478Asirwatham M, Konanki V, Lucas SJ, Grundy S, Zwiebel B, Shames M, Arnaoutakis DJ. Comparative outcomes of physician-modified fenestrated/branched endovascular aortic aneurysm repair in the setting of prior failed endovascular aneurysm repair. J Vasc Surg. 2023 Nov;78(5):1153-1161. doi: 10.1016/j.jvs.2023.07.002. Epub 2023 Jul 13.
PubMed 37451371