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Physician Modified Endograft For Complex Aortic Aneurysm Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05339061
Recruitment Status : Not yet recruiting
First Posted : April 21, 2022
Last Update Posted : October 13, 2022
Sponsor:
Information provided by (Responsible Party):
Andrew Barleben, University of California, San Diego

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.


Condition or disease Intervention/treatment Phase
Complex Abdominal Aortic Aneurysm Juxtarenal Aortic Aneurysm Pararenal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm Device: Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA). Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a prospective, single-center, non-randomized, single-arm study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physician-Modified Endograft
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).

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




Primary Outcome Measures :
  1. The Primary Safety Endpoint (Freedom from major adverse events [MAE]) [ Time Frame: At 30 days or during hospitalization if this exceeds 30 days. ]
    Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.

  2. Primary effectiveness endpoint [ Time Frame: The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year. ]

    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)


Secondary Outcome Measures :
  1. Technical success [ Time Frame: Procedural ]

    Technical success and the individual components of technical success:

    • Successful delivery
    • Deployment at the intended implantation site
    • Patency of all endovascular graft and stent components
    • Absence of device deformations requiring unplanned placement of an additional device
    • Absence of inadvertent occlusion of aorta or aortic branch vessels
    • Successful withdrawal of delivery systems

  2. The individual components of the primary safety endpoint at 30 days or during hospitalization if this exceeds 30 days [ Time Frame: At 30 days or during hospitalization if this exceeds 30 days. ]
    • All-cause mortality
    • Myocardial infarction
    • Respiratory failure requiring prolonged (>24 hours from anticipated) mechanical ventilation or reintubation
    • Renal function decline resulting in >50% reduction in baseline eGFR or new-onset dialysis
    • Bowel ischemia requiring surgical resection or not resolving with medical therapy
    • Major stroke
    • Paraplegia

  3. Follow-up outcomes [ Time Frame: The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. ]

    The following at each follow-up interval:

    o Treatment success and the individual components of treatment success including freedom from the following:

    • Aneurysm sac changes (i.e enlargement, shrinkage, no change)
    • Aneurysm-related mortality
    • Aneurysm rupture
    • Conversion to open repair
    • Secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e., fracture), and patency-related events (i.e., device stenosis or occlusion and embolic events).
    • Renal failure
    • All-cause mortality
    • Endoleaks
    • Device integrity failure (e.g., fracture)
    • Patency-related events (i.e., device stenosis or occlusion and embolic events)
    • Other device-related events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

---Inclusion criteria---

  1. Patient is > 18 years of age
  2. 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)
  3. Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
  4. 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
  5. Cannot be treated with a currently available non-modified approved device
  6. High risk for open surgical repair based on any of the factors below:

    1. 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
    2. 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
  7. 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
  8. Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm
  9. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.
  10. The resultant repair should preserve patency in at least one hypogastric artery.
  11. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm
  12. Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm.

---Exclusion Criteria---

-General Exclusion Criteria-

  1. Patient has a mycotic aneurysm
  2. Patient has a ruptured aneurysm requiring urgent or emergent repair
  3. Patient has a systemic or local infection that may increase the risk of graft infection
  4. Patient has a body habitus that would inhibit X-ray visualization of the aorta.
  5. Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution
  6. Patient has a major surgical or interventional procedure planned within +/- 30 days of the (T)AAA repair.
  7. Patient is currently participating in another investigational device or drug clinical trial.

-Medical Exclusion Criteria-

  1. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
  2. Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold.
  3. Patient has uncorrectable coagulopathy
  4. 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)
  5. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
  6. Patient has active malignancy with life expectancy of less than 2 years
  7. Patient has a limited life expectancy of less than 2 years.
  8. 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.

-Anatomic Exclusion Criteria-

  1. Significant occlusive disease, tortuosity or calcification that would prevent endovascular access
  2. Proximal seal site with a circumferential thrombus/atheroma
  3. Inability to maintain at least one patent hypogastric artery
  4. Shaggy aorta
  5. Patient is not amenable to a temporary or permanent open surgical or endovascular conduit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05339061


Contacts
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Contact: Sina Zarrintan, MD 8582463003 szarrintan@health.ucsd.edu
Contact: Kathleen Groh, BS 8582463003 kagroh@health.ucsd.edu

Sponsors and Collaborators
University of California, San Diego
Publications:

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Responsible Party: Andrew Barleben, Associate Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05339061    
Other Study ID Numbers: 803596
First Posted: April 21, 2022    Key Record Dates
Last Update Posted: October 13, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases