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Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

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ClinicalTrials.gov Identifier: NCT02989948
Recruitment Status : Not yet recruiting
First Posted : December 12, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
David P. Kuwayama, Dartmouth-Hitchcock Medical Center

Brief Summary:
The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith TX2 aortic endograft as compared to previously published results of open surgical replacement of the aneurysmal aorta.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracoabdominal Device: Physician-modified aortic endograft Not Applicable

Detailed Description:
This study is a prospective, single-arm, traditional feasibility study of a physician-modified fenestrated Cook Zenith TX2 aortic endograft base device in adult patients meeting traditional size criteria for open surgical treatment of thoracoabdominal aortic aneurysms. Patients meriting surgical treatment of their aneurysm that also meet inclusion and exclusion criteria will be eligible for enrollment. Patients will be followed for 5 years post procedure. Major adverse events will also be recorded by the Sponsor-Investigator and will be monitored by a locally appointed Data Monitoring Committee, the Institutional Review Board, and the FDA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physician-modified aortic endograft
Physician-modified fenestrated endografting for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.
Device: Physician-modified aortic endograft
Physician-modified fenestrated endografting for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.




Primary Outcome Measures :
  1. 30 day survival [ Time Frame: 30 Days ]
    Percent of Patients who Survive at 30 days

  2. Adverse Events at 30 days [ Time Frame: 30 Days ]
    Percent of Patients who Development Major Adverse Events

  3. One Year Treatment Success [ Time Frame: 1 Year ]
    Percent of Patients Achieving Treatment Success through 1 year


Secondary Outcome Measures :
  1. Technical Success [ Time Frame: Day of Surgery ]
    Percent of Patients Achieving Technical Success on the day of surgery

  2. Aneurysm rupture [ Time Frame: Day of Surgery ]
    Percent of Patients Developing Aneurysm rupture

  3. Conversion to Open Repair [ Time Frame: Day of Surgery ]
    Percent of Patients Necessitating Conversion to Open Repair. This is assessed intraoperatively. In case of a device deployment failure or intraoperative aneurysm rupture, emergent conversion to open repair via laparotomy, thoracotomy, or thoracoabdominal aortic exposure may become necessary. Patients undergoing such intraoperative conversion will be considered to have met this endpoint.

  4. Access Site Complication (Femoral or Iliac) [ Time Frame: Day of Surgery ]
    Percent of Patients Suffering Access Site Complication (Femoral or Iliac). If femoral or iliac rupture occurs intraoperatively, or if femoral or iliac flow-limiting dissection or occlusion is identified intraoperatively or on the day of surgery, patients will be considered to have met this outcome.

  5. Lower Extremity Ischemia [ Time Frame: Day of Surgery ]
    Percent of Patients Developing Lower Extremity Ischemia. This will be assess intraoperatively and on the day of surgery. If patients have lower extremity pulses either absent or diminished compared to baseline, with associated pain, sensory deficits or motor deficits on clinical evaluation, patients will be considered to have met this outcome.

  6. Lower Extremity Compartment Syndrome [ Time Frame: Day of Surgery ]
    Percent of Patients Developing Lower Extremity Compartment Syndrome. In patients with lower extremity pain to passive motion post-operatively, invasive pressure measurement of the four calf compartments will be performed. If compartment pressures are greater than 30 in any compartment, patients will be considered to have met this outcome.

  7. Stroke [ Time Frame: Day of Surgery ]
    Percent of Patients Developing Stroke - Modified Rankin Score (MRS) of 2 or greater). In patients with altered mental status or lateralizing motor or sensory deficits, MRI of the brain will be performed. If diffusion weighted MRI imaging demonstrates an intracranial lesion, a modified Rankin score will be calculated. If MRS is 2 or greater, patients will be considered to have met this outcome.

  8. Paraplegia [ Time Frame: Day of Surgery ]
    Percent of Patients Developing Paraplegia. Patients with complete absence of lower extremity motor function in one or both legs will be considered to have met this outcome.

  9. Paraparesis [ Time Frame: Day of Surgery ]
    Percent of Patients Developing Paraparesis. Patients will undergo lower extremity motor strength assessment post-operatively on a standard 0 to 5 scale. If greater than 0 but less than 5 in either extremity, patients will be considered to have met this outcome.

  10. Death during surgery [ Time Frame: Day of Surgery ]
    Percent of Patients who die during surgery

  11. Survival rate [ Time Frame: At 90, 183 days; 1, 2, 3, 4 and 5 years ]
    Percent of Patients who Survive

  12. Major Adverse Events Events [ Time Frame: At 90, 183 days; 1, 2, 3, 4 and 5 years ]
    Percent of Patients that Development Major Adverse

  13. Treatment success [ Time Frame: At 30, 90, 183 days; 2, 3, 4 and 5 years ]
    Percent of Patients Achieving Treatment Success



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:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be a man or woman 50 years of age or older by the date of informed consent.
  2. Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
  3. Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta).
  4. Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.
  5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.
  6. Patient or their legal authorized representative (LAR) must be able to provide informed consent.
  7. Must be able to comply with the five year study assessment schedule of events.
  8. Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years.

Exclusion Criteria:

  1. Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.
  2. Ruptured or acutely symptomatic aortic aneurysm.
  3. Known connective tissue disorder.
  4. Imaging demonstrating any of the following:

    • Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition).
    • Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac).
    • Branch vessel target (renal, superior mesenteric, or celiac) < 5 mm or > 10 mm in average diameter.
    • Untreated left subclavian artery stenosis or occlusion.
    • Untreated unilateral or bilateral hypogastric artery occlusion.
    • Signs that the inferior mesenteric artery is indispensable.
    • Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices.
  5. Known allergy to stainless steel or polyester.
  6. History of anaphylaxis to contrast, with inability to prophylax appropriately.
  7. Have uncorrectable coagulopathy.
  8. Have unstable angina.
  9. Have a body habitus that would inhibit X-ray visualization of the aorta.
  10. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.
  11. Known to be participating in any other clinical study which may affect performance of this device.
  12. Known or visible pregnancy.
  13. Contraindication to oral antiplatelet therapy.
  14. Prisoners or those on alternative sentencing.
  15. Known systemic infection with potential for endovascular graft infection.
  16. Anticipated need for MRI scanning within 3 months of insertion of investigational product.
  17. Other conditions or comorbidities that, in the opinion of the Sponsor-Investigator, would exclude the patient.

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): NCT02989948


Contacts
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Contact: Allison J Hawke 603-650-7985 allison.j.hawke@hitchcock.org

Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Allison Hawke    603-650-7985    allison.j.hawke@hitchcock.org   
Contact: Cristina Ferrazzano Yaussy    603-653-3411    Cristina.Ferrazzano.Yaussy@hitchcock.org   
Principal Investigator: David P. Kuwayama, M.D., M.P.A.         
Sponsors and Collaborators
David P. Kuwayama
Investigators
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Principal Investigator: David P. Kuwayama, M.D., M.P.A. Dartmouth-Hitchcock Medical Center

Publications:

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Responsible Party: David P. Kuwayama, Staff Physician, Vascular Surgery, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02989948     History of Changes
Other Study ID Numbers: D18194
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No plan to share individual participant data (IPD) exists at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by David P. Kuwayama, Dartmouth-Hitchcock Medical Center:
Endovascular

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases