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Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

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ClinicalTrials.gov Identifier: NCT04746677
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Marc L. Schermerhorn, MD, Beth Israel Deaconess Medical Center

Brief Summary:
The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm Aortic Dissection Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG) Not Applicable

Detailed Description:

Complex aortic pathology, comprised of aneurysmal disease and aortic dissection involving the visceral aortic segment, presents a technical challenge for repair due to involvement of the renal and/or mesenteric arteries. Traditionally, the gold standard for repair has been open repair. However, open repair of these diseases is associated with high perioperative morbidity and mortality. Therefore, for patients with significant medical comorbidities or complex surgical/anatomical features, the risk of open surgery may be prohibitive.

As endovascular techniques have become increasingly advanced, options for the endovascular treatment of complex aortic pathology involving the visceral segment have been developed. The predominant approach is fenestrated or branched endovascular aortic repair (F/B-EVAR) with fenestrated or branched endovascular grafts. Currently, there is only one device FDA-approved for commercial use in the United States, the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, IN). However, its use is limited by the design specifications of the device and the required manufacturing time in patients requiring more urgent repair. Therefore, many patients with complex aortic pathology are not eligible for repair with this device, and there are currently no other FDA-approved options for definitive repair.

One option for definitive repair of complex aortic pathology in patients ineligible for the Zenith fenestrated device is endovascular repair with a physician-modified endovascular graft (PMEG). For this procedure, the operating surgeon modifies an FDA-approved endovascular graft to incorporate fenestrations or branches based on the patient's anatomy. Numerous reports have been published demonstrating that this procedure can be performed with high technical success, and acceptable perioperative and mid-term results in high-risk patients.

The primary objective of the study is to evaluate safety and effectiveness of PMEGs for the endovascular repair of complex aortic pathology in high-risk patients. The safety outcomes include perioperative mortality (defined as death <30 days postoperative or during the index hospitalization) and major adverse events, along with mortality and adverse events during follow-up. Effectiveness outcomes include initial technical success, endoleak rate, target vessel patency, and rate of reintervention. Patients will be followed for five years. Patients will be evaluated preoperatively, at the time of the procedure, at the time of discharge from the index hospitalization, 1-month post-procedure, 6-months post-procedure, and 1-year post-procedure, and annually for five-years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Complex abdominal aortic aneurysm (AAA)
Includes juxtarenal AAA, suprarenal AAA, and type IV thoracoabdominal aortic aneurysm
Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)

Experimental: Thoracoabdominal aortic aneurysm (TAAA)
Includes Type I, Type II, and Type III TAAA
Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)

Experimental: Type B aortic dissection Device: Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
Endovascular aortic repair with a physician-modified endovascular graft (PMEG)




Primary Outcome Measures :
  1. Perioperative mortality [ Time Frame: Up to 30-days after surgery ]
    Rate of death

  2. Perioperative major adverse events [ Time Frame: Up to 30-days after surgery ]

    Rates of:

    • Stroke
    • Respiratory failure (defined as postoperative intubation >48 hours or reintubation)
    • Myocardial infarction
    • Bowel ischemia requiring treatment
    • Renal failure requiring dialysis
    • Acute limb ischemia
    • Paraplegia

  3. All-cause mortality [ Time Frame: 30-days to 5-years ]
    Rate of death due to any cause at: 30-days, 6-months, 1-year, and annually to 5-years

  4. Aneurysm-related mortality [ Time Frame: 30-days to 5-years ]
    Rate of aneurysm-related death at: 30-days, 6-months, 1-year, and annually to 5-years

  5. Long-term major adverse events [ Time Frame: 6-months to 5-years ]

    Rate of major adverse events at: 6-months, 1-year, and annually to 5-years

    Long-term major adverse event is defined as having at least one of the following:

    • Death
    • Stroke (deemed related to the device, the procedure, or a reintervention)
    • Bowel ischemia requiring treatment (deemed related to the device, the procedure, or a reintervention)
    • Renal failure requiring dialysis (deemed related to the device, the procedure, reintervention, or follow-up imaging)
    • Acute limb ischemia (deemed related to the device, the procedure, or a reintervention)

  6. Technical success [ Time Frame: 24 hours ]
    Defined as successful delivery of the physician-modified graft in the planned location with patency of all intended target vessels and without unintentional coverage of any aortic branches, along with successful removal of the delivery system

  7. Device-related reintervention [ Time Frame: 30-days to 5-years ]
    Rate of device-related reintervention at: 30-days, 6-months, 1-year, and annually to 5-years

  8. Aneurysm rupture [ Time Frame: 30-days to 5-years ]
    Rate of aneurysm rupture at: 30-days, 6-months, 1-year, and annually to 5-years

  9. Conversion to open repair [ Time Frame: 30-days to 5-years ]
    Rate of conversion to open repair at: 30-days, 6-months, 1-year, and annually to 5-years

  10. Endoleaks [ Time Frame: 30-days to 5-years ]
    Rate of Type I, II, III, IV, and V endoleaks at: 30-days, 6-months, 1-year, and annually to 5-years

  11. Main device occlusion [ Time Frame: 30-days to 5-years ]
    Rate of main device occlusion at: 30-days, 6-months, 1-year, and annually to 5-years

  12. Target vessel patency [ Time Frame: 30-days to 5-years ]
    Rate of target vessel patency at: 30-days, 6-months, 1-year, and annually to 5-years

  13. Residual aneurysm sac status [ Time Frame: 6-months, 1-year, and annually to 5-years ]

    Rate of residual sac status (stable, regressing, expanding) at 6-months, 1-year, and annually to 5-years, defined as the following:

    • Stable: maximum diameter within 5 mm of the diameter at 30-day follow-up
    • Regressing: maximum diameter ≥5 mm less than the diameter at 30-day follow-up
    • Expanding: maximum diameter ≥5 mm greater than the diameter at 30-day follow-up



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

INCLUSION CRITERIA:

General inclusion criteria (applicable to all 3 study arms):

  • Aortic pathology that fits one of the study arms (see below for detailed description)
  • Aortic pathology that cannot be treated within the Instructions for Use of an FDA- approved, commercially-available device
  • Aortic aneurysm that can be treated within the Instructions for Use of an FDA-approved, commercially-available custom-manufactured device but deemed unsafe to wait the required time for device manufacturing
  • Subject is at high-risk of morbidity and mortality with open surgical repair based on cardiopulmonary function, extent of comorbid disease, and anatomic complexity
  • Iliac and/or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical or endovascular conduit
  • Non-aneurysmal aortic segment proximal to the aortic pathology with a:

    • Minimum neck length of 20 mm
    • Diameter between 20 - 42 mm
  • Non-aneurysmal aortic or iliac segment distal to the aortic pathology with:

    • Aortic distal fixation site greater than 20 mm in length and diameter between 20-42 mm
    • Iliac artery distal fixation site greater than 10 mm in length and diameter range 8- 25 mm
  • Age ≥21 years old
  • Life expectancy: ≥2 years

Arm1:

  • Complex abdominal aortic aneurysm, specifically juxtarenal or suprarenal abdominal aortic aneurysm or type IV thoracoabdominal aortic aneurysm, with maximum diameter of ≥5.5 cm for men or ≥5.0 cm for women, growth ≥0.5 cm in 6 months, or concomitant iliac aneurysm ≥3 cm
  • Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease extending above the diaphragmatic hiatus
  • Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, without aneurysmal disease above the diaphragmatic hiatus
  • Saccular complex abdominal aortic aneurysm deemed at significant risk for rupture
  • Symptomatic complex aortic aneurysm
  • Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus
  • Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, without involvement of the aorta above the diaphragmatic hiatus

Arm2:

  • Type I, II, or III thoracoabdominal aortic aneurysm with maximum diameter of ≥5.5 cm, or growth ≥0.5 cm in 6 months
  • Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair with aneurysmal disease extending above the diaphragmatic hiatus
  • Prior thoracic endovascular aneurysm repair with loss of distal seal requiring incorporation of the renal arteries, SMA, and/or CA for repair
  • Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and/or CA for repair, with aneurysmal disease above the diaphragmatic hiatus
  • Saccular type I, II, or III thoracoabdominal aortic aneurysm deemed at significant risk for rupture
  • Symptomatic type I, II, or III thoracoabdominal aortic aneurysm
  • Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus
  • Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and/or CA, with involvement of the aorta above the diaphragmatic hiatus

Arm 3:

  • Acute or chronic type B aortic dissection with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or persistence of symptoms despite optimal medical therapy
  • Prior repair of type A dissection and development of acute or chronic type B dissection component with indication for repair (listed above)
  • Aortic intramural hematoma (IMH) with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or more typically, persistence of symptoms despite optimal medical therapy

EXCLUSION CRITERIA:

General Exclusion Criteria

  • Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
  • Subject is unwilling to comply with the follow-up schedule
  • Inability or refusal to give informed consent by subject or legal representative
  • Subject is pregnant or breastfeeding
  • Subject has a ruptured aneurysm

Medical Exclusion Criteria

  • Known sensitivities or allergies to the materials of construction of the devices
  • Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
  • Uncorrectable coagulopathy
  • Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
  • Systemic or local infection that may increase the risk of endovascular graft infection
  • Diagnosis of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)

Anatomic Exclusion Criteria

  • Inability to perform open or endovascular iliac conduit in patients with inadequate femoral/iliac access
  • Excessive thrombus or calcification within the neck of the aneurysm
  • Visceral vessel anatomy not compatible with placement of a physician-modified endovascular graft due to occlusive disease or small size

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): NCT04746677


Contacts
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Contact: Theresa Bishop, BSN 617-632-9975 tbishop@bidmc.harvard.edu
Contact: Mary Trovato 617-632-7488 mtrovato@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Theresa Bishop    617-632-9975    tbishop@bidmc.harvard.edu   
Contact: Mary Trovato    617-632-7488    mtrovato@bidmc.harvard.edu   
Principal Investigator: Marc L Schermerhorn, MD         
Sub-Investigator: Nicholas J Swerdlow, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Layout table for additonal information
Responsible Party: Marc L. Schermerhorn, MD, Chief, Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04746677    
Other Study ID Numbers: G200288
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 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
Keywords provided by Marc L. Schermerhorn, MD, Beth Israel Deaconess Medical Center:
Fenestrated endovascular aortic repair
Branched endovascular aortic repair
Complex aortic aneurysm repair
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aneurysm, Dissecting
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases