Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies

NCT04524247 | Recruiting DMC FDA Device

• 1 other identifier: APP-20-04282
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.

Conditions

Thoracoabdominal Aortic Aneurysm; Thoracoabdominal; Aortic, Aneurysm, Dissecting; Pararenal Aneurysm; Frailty Syndrome

Outcome Measures

Primary Outcomes (1)

• Rate of Major Adverse Events

  1. Aortic rupture within 30 days 2. Lesion-related mortality within 30 days 3. All-cause mortality within 30 days 4. Permanent paraplegia, defined by lack of resolution at 1 month follow-up 5. Permanent paraparesis, defined by lack of resolution at 1 month follow-up 6. Renal function decline resulting in \> 50% of estimated Glomerular Filtration Rate or New onset renal failure requiring dialysis, defined by ongoing dialysis at 1 month follow-up 7. Severe bowel ischemia, requiring laparotomy 8. Disabling stroke, reported within 30 days of the procedure, without resolution at 90 days post-procedure 9. Myocardial infarction 10. Respiratory failure requiring prolonged (\> 24 hours from anticipated) mechanical ventilation or reintubation

  Immediately after the surgery up to 30 days. If the hospital stay exceeds 30 days, major adverse events that occur prior to discharge from hospital will be included.

Secondary Outcomes (2)

• Rate of Technical Success

  Immediately after the surgery

• Rate of Treatment Success

  30-days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years

Study Arms (1)

PMEG FEVAR

EXPERIMENTAL

The only arm of this study will be enrolled subjects who undergo physician modified endografting as a treatment of their thoracoabdominal aortic aneurysms or complex abdominal aortic aneurysms.

Device: Physician Modified Endografts

Interventions

Physician Modified Endografts DEVICE

Modification procedure Description of modified device is detailed in Section 3.5 of IDE. In summary, the steps involved in modification of the Zenith Alpha thoracic stent grafts are; 1. Unsheathing of the stent graft 2. Retrieval of a trigger wire from the inner cannula of the delivery system 3. Rerouting of the trigger wire along the stent graft 4. Removal of proximal barbs. 5. Creation of fenestrations and/or branch cuffs 6. Placement of radiopaque markers around the fenestrations/ branch cuffs 7. Placement of temporary and/or permanent diameter constraining ties 8. (Optional) Placement of preloaded wires through the fenestrations/branch cuffs

Also known as: Fenestrated, Branched Endografts

PMEG FEVAR

Eligibility Criteria

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

You may qualify if:

• Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated/branched stent grafts.
• Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter.
• Aneurysm with a history of growth ≥ 0.5cm per year.
• Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.
• Symptomatic aneurysm without hemodynamic instability
• Aneurysms meeting any of the above criteria 1\~4, above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.

You may not qualify if:

• Patients must be excluded from the study if any of the following conditions is true:
• Less than 18 years of age.
• Unwilling to comply with the follow-up schedule.
• Inability or refusal to give informed consent by the patient or a legally authorized representative.
• Pregnant or breastfeeding.
• Life-expectancy less than 2 years.
• Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol and performed remotely from the fenestrated procedure (\>30 days). Examples include remote (\>30days) participation in a thoracic, or abdominal branch device trial.
• Eligible for treatment with FDA-approved marketed device.
• Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Hospital of University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (13)

• Uflacker R, Robison JD, Schonholz C, Ivancev K. Clinical experience with a customized fenestrated endograft for juxtarenal abdominal aortic aneurysm repair. J Vasc Interv Radiol. 2006 Dec;17(12):1935-42. doi: 10.1097/01.RVI.0000248828.92093.1A.

  PMID: 17185689 BACKGROUND

• Amiot S, Haulon S, Becquemin JP, Magnan PE, Lermusiaux P, Goueffic Y, Jean-Baptiste E, Cochennec F, Favre JP; Association Universitaire de Recherche en Chirurgie Vasculaire. Fenestrated endovascular grafting: the French multicentre experience. Eur J Vasc Endovasc Surg. 2010 May;39(5):537-44. doi: 10.1016/j.ejvs.2009.12.008. Epub 2010 Jan 25.

  PMID: 20093051 BACKGROUND

• Verhoeven EL, Katsargyris A, Bekkema F, Oikonomou K, Zeebregts CJ, Ritter W, Tielliu IF. Editor's Choice - Ten-year Experience with Endovascular Repair of Thoracoabdominal Aortic Aneurysms: Results from 166 Consecutive Patients. Eur J Vasc Endovasc Surg. 2015 May;49(5):524-31. doi: 10.1016/j.ejvs.2014.11.018. Epub 2015 Jan 17.

  PMID: 25599593 BACKGROUND

• Mastracci TM, Greenberg RK, Eagleton MJ, Hernandez AV. Durability of branches in branched and fenestrated endografts. J Vasc Surg. 2013 Apr;57(4):926-33; discussion 933. doi: 10.1016/j.jvs.2012.09.071. Epub 2013 Feb 20.

  PMID: 23433817 BACKGROUND

• O'Neill S, Greenberg RK, Haddad F, Resch T, Sereika J, Katz E. A prospective analysis of fenestrated endovascular grafting: intermediate-term outcomes. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):115-23. doi: 10.1016/j.ejvs.2006.01.015. Epub 2006 Mar 31.

  PMID: 16580236 BACKGROUND

• British Society for Endovascular Therapy and the Global Collaborators on Advanced Stent-Graft Techniques for Aneurysm Repair (GLOBALSTAR) Registry. Early results of fenestrated endovascular repair of juxtarenal aortic aneurysms in the United Kingdom. Circulation. 2012 Jun 5;125(22):2707-15. doi: 10.1161/CIRCULATIONAHA.111.070334.

  PMID: 22665884 BACKGROUND

• Reilly LM, Rapp JH, Grenon SM, Hiramoto JS, Sobel J, Chuter TA. Efficacy and durability of endovascular thoracoabdominal aortic aneurysm repair using the caudally directed cuff technique. J Vasc Surg. 2012 Jul;56(1):53-63; discussion 63-4. doi: 10.1016/j.jvs.2012.01.006. Epub 2012 May 3.

  PMID: 22560233 BACKGROUND

• Starnes BW, Heneghan RE, Tatum B. Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms. J Vasc Surg. 2017 Feb;65(2):294-302. doi: 10.1016/j.jvs.2016.07.123. Epub 2016 Sep 26.

  PMID: 27687323 BACKGROUND

• Scali ST, Neal D, Sollanek V, Martin T, Sablik J, Huber TS, Beck AW. Outcomes of surgeon-modified fenestrated-branched endograft repair for acute aortic pathology. J Vasc Surg. 2015 Nov;62(5):1148-59.e2. doi: 10.1016/j.jvs.2015.06.133. Epub 2015 Aug 5.

  PMID: 26254453 BACKGROUND

• Tsilimparis N, Heidemann F, Rohlffs F, Diener H, Wipper S, Debus ES, Kolbel T. Outcome of Surgeon-Modified Fenestrated/Branched Stent-Grafts for Symptomatic Complex Aortic Pathologies or Contained Rupture. J Endovasc Ther. 2017 Dec;24(6):825-832. doi: 10.1177/1526602817729673. Epub 2017 Sep 6.

  PMID: 28874089 BACKGROUND

• Georgiadis GS, van Herwaarden JA, Antoniou GA, Hazenberg CE, Giannoukas AD, Lazarides MK, Moll FL. Systematic Review of Off-the-Shelf or Physician-Modified Fenestrated and Branched Endografts. J Endovasc Ther. 2016 Feb;23(1):98-109. doi: 10.1177/1526602815611887. Epub 2015 Oct 23.

  PMID: 26496957 BACKGROUND

• O'Donnell TFX, Patel VI, Deery SE, Li C, Swerdlow NJ, Liang P, Beck AW, Schermerhorn ML. The state of complex endovascular abdominal aortic aneurysm repairs in the Vascular Quality Initiative. J Vasc Surg. 2019 Aug;70(2):369-380. doi: 10.1016/j.jvs.2018.11.021. Epub 2019 Feb 2.

  PMID: 30718110 BACKGROUND

• Han SM, Tenorio ER, Mirza AK, Zhang L, Weiss S, Oderich GS. Low-profile Zenith Alpha Thoracic Stent Graft Modification Using Preloaded Wires for Urgent Repair of Thoracoabdominal and Pararenal Abdominal Aortic Aneurysms. Ann Vasc Surg. 2020 Aug;67:14-25. doi: 10.1016/j.avsg.2020.02.022. Epub 2020 Mar 20.

  PMID: 32205248 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aneurysm; Frailty

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sukgu M Han, MD, MS

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie O'Donnell, MPH

CONTACT

323-442-6835; Kathleen.O'Donnell@med.usc.edu

Jacquelyn Paige, MSN, RN

CONTACT

323-865-1545; Jacquelyn.Paige@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy, University of Southern California

Model Details: Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated/branched stent grafts. 1. Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter. 2. Aneurysm with a history of growth ≥ 0.5cm per year. 3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation. 4. Symptomatic aneurysm without hemodynamic instability 5. Aneurysms meeting any of the above criteria 1\~4, above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 24, 2020
• Study Start: February 23, 2021
• Primary Completion (Estimated): July 2, 2028
• Study Completion (Estimated): July 2, 2032
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)