Physician Modified Endograft For Complex Aortic Aneurysm Repair

NCT05339061 | Recruiting FDA Device

• 1 other identifier: 803596
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.

Conditions

Complex Abdominal Aortic Aneurysm; Juxtarenal Aortic Aneurysm; Pararenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• The Primary Safety Endpoint (Freedom from major adverse events [MAE])

  Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.

  At 30 days or during hospitalization if this exceeds 30 days.

• Primary effectiveness endpoint

  Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement \[i.e., \>5mm as compared to any previous CT measure using orthogonal (i.e, perpendicular to the centerline) measurements\] * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)

  The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.

Secondary Outcomes (3)

• Technical success

  Procedural

• The individual components of the primary safety endpoint at 30 days or during hospitalization if this exceeds 30 days

  At 30 days or during hospitalization if this exceeds 30 days.

• Follow-up outcomes

  The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years.

Study Arms (1)

Physician-Modified Endograft

EXPERIMENTAL

This is a single arm study used to evaluate the safety and effectiveness of fenestrated and branched techniques for the treatment of patients with a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysms (Extent I-V).

Device: Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).

Interventions

Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA). DEVICE

Modification * Deploy the graft on the sterile, surgical table * Mark out on the graft the locations of the fenestrations on the graft adjusting as necessary * Using handheld electrocautery, fashion the fenestration in the appropriate location on the moistened graft material in order to prevent inadvertent progression of the fenestration size * If the fenestration is going to remain as such, then a snare is used to fashion the marker on the fenestration with 5-0 stitch * If the fenestration is going to be made into a branch, then an appropriately sized, self-expanding stent is beveled and fashioned to be 15 mm long and sewn to the fenestration in addition to a snare with the 5-0 stitch * Two orientation markers are placed at the proximal edge and distal edge of the graft consisting of portions of the snare sewn to the anterior portion of the graft in a J fashion with a 5-0 stitch

Physician-Modified Endograft

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 is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
• Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following:
• Aortic aneurysm with diameter ≥ 5.5cm
• Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months
• Symptomatic aortic aneurysm
• Cannot be treated with a currently available non-modified approved device
• High risk for open surgical repair based on any of the factors below:
• Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery
• Physiologic i. ASA Category III or higher ii. Age \>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD
• Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft or is suitable for an iliac conduit
• Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm
• Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.
• The resultant repair should preserve patency in at least one hypogastric artery.

You may not qualify if:

• Patient has a mycotic aneurysm
• Patient has a ruptured aneurysm requiring urgent or emergent repair
• Patient has a systemic or local infection that may increase the risk of graft infection
• Patient has a body habitus that would inhibit X-ray visualization of the aorta.
• Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution
• Patient has a major surgical or interventional procedure planned within +/- 30 days of the (T)AAA repair.
• Patient is currently participating in another investigational device or drug clinical trial.
• Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
• Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold.
• Patient has uncorrectable coagulopathy
• 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 history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
• Patient has active malignancy with life expectancy of less than 2 years
• Patient has a limited life expectancy of less than 2 years.
• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• University of California, San Diego: collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92037, United States

RECRUITING

Related Publications (12)

• 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

• Farber MA, Vallabhaneni R, Marston WA. "Off-the-shelf" devices for complex aortic aneurysm repair. J Vasc Surg. 2014 Sep;60(3):579-84. doi: 10.1016/j.jvs.2014.03.258. Epub 2014 May 3.

  PMID: 24797555 BACKGROUND

• Starnes BW. Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. J Vasc Surg. 2012 Sep;56(3):601-7. doi: 10.1016/j.jvs.2012.02.011. Epub 2012 May 2.

  PMID: 22554425 BACKGROUND

• Sweet MP, Starnes BW, Tatum B. Endovascular treatment of thoracoabdominal aortic aneurysm using physician-modified endografts. J Vasc Surg. 2015 Nov;62(5):1160-7. doi: 10.1016/j.jvs.2015.05.036. Epub 2015 Jul 17.

  PMID: 26194816 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

• 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: 30583902 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

• Ronchey S, Serrao E, Kasemi H, Pecoraro F, Fazzini S, Alberti V, Mangialardi N. Endovascular treatment options for complex abdominal aortic aneurysms. J Vasc Interv Radiol. 2015 Jun;26(6):842-54. doi: 10.1016/j.jvir.2015.02.021. Epub 2015 Apr 14.

  PMID: 25887934 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

• Senemaud JN, Ben Abdallah I, de Boissieu P, Touma J, Kobeiter H, Desgranges P, Becquemin JP, Cochennec F. Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms. J Vasc Surg. 2020 Jun;71(6):1834-1842.e1. doi: 10.1016/j.jvs.2019.07.102. Epub 2019 Nov 7.

  PMID: 31708298 BACKGROUND

• Singh A, Mafeld S, Williams R, McCaslin J. Physician-Modified Fenestrated Endografts for Managing the Ruptured or Symptomatic Aortic Aneurysm: Technique Overview and Clinical Outcomes. Vasc Endovascular Surg. 2018 Nov;52(8):607-612. doi: 10.1177/1538574418789023. Epub 2018 Jul 22.

  PMID: 30033825 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

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Sina Zarrintan, MD

CONTACT

8582463003; szarrintan@health.ucsd.edu

Kathleen Groh

CONTACT

8585348103; kagroh@health.ucsd.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

Model Details: This study is a prospective, single-center, non-randomized, single-arm study.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)