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Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

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ClinicalTrials.gov Identifier: NCT03113383
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2017
Last Update Posted : October 5, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Thomas Naslund, Vanderbilt University Medical Center

Brief Summary:

The primary objective of the clinical investigation is to assess the use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year).

Additionally, the study will assess technical success and treatment success at each follow-up interval.


Condition or disease Intervention/treatment Phase
Thoracoabdominal Aortic Aneurysm Device: Thoracoabdominal Aortic Aneurysm Repair Not Applicable

Detailed Description:

The primary purpose of this study is to evaluate the safety of this device as there are no or very limited devices and clinical options available for this patient population. The primary safety endpoint of this study is safety freedom from major adverse events (MAE) 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. The primary safety endpoint will be analyzed to determine statistical significance when compared to a target performance goal. A literature review of outcomes of open surgical repair was used to create the performance goal as there is not a comparable endovascular option to use for analysis. The performance goal was selected based on the range of subjects experiencing a major adverse event at 30 days. The range was calculated based on assumptions of the minimum and maximum number of subjects experiencing at least one MAE in the historical open surgical repair group . Based on the literature reviewed and the above assumptions the range of subjects experiencing at least one MAE in the open surgical repair group is 30.5% to 77.4%.

The primary effectiveness endpoint is the proportion of the study subjects with treatment success at 1 year. The data will be presented as quality outcomes with the number of study subjects with treatment success compared to the overall patient population.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thoracoabdominal Aortic Aneurysm Repair
Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
Device: Thoracoabdominal Aortic Aneurysm Repair
Thoracoabdominal aortic aneurysm repair




Primary Outcome Measures :
  1. Safety Endpoint: Freedom from major adverse events [ Time Frame: 30 days ]
    Freedom from major adverse events (MAE) at 30 days.

  2. Preliminary Effectiveness [ Time Frame: 1 year ]
    Proportion of subjects treated with the device that achieve and maintain treatment success at 1 year.


Secondary Outcome Measures :
  1. Secondary Safety Endpoint:Freedom from major adverse events [ Time Frame: 6 months ]
    Freedom from major adverse events (MAE) at 6 Months.

  2. Secondary Safety Endpoint: Freedom from major adverse events [ Time Frame: 1 year. ]
    Freedom from major adverse events (MAE) at 1 year.

  3. Secondary Safety Endpoint: Freedom from major adverse events [ Time Frame: 2 years. ]
    Freedom from major adverse events (MAE) at 2 years.

  4. Secondary Safety Endpoint: Freedom from major adverse events [ Time Frame: 3 years. ]
    Freedom from major adverse events (MAE) at 3 years.

  5. Secondary Safety Endpoint: Freedom from major adverse events [ Time Frame: 4 years. ]
    Freedom from major adverse events (MAE) at 4 years.

  6. Secondary Safety Endpoint: Freedom from major adverse events [ Time Frame: 5 years. ]
    Freedom from major adverse events (MAE) at 5 years.

  7. Secondary Effectiveness Assessment [ Time Frame: 30 days. ]
    Proportion of subjects treated with the device that achieve and maintain treatment success at 30 days as defined by aneurysm exclusion.

  8. Secondary Effectiveness Assessment [ Time Frame: 6 months. ]
    Proportion of subjects treated with the device that achieve and maintain treatment success at 6 months as defined by aneurysm exclusion.

  9. Secondary Effectiveness Assessment [ Time Frame: 2 years. ]
    Proportion of subjects treated with the device that achieve and maintain treatment success at 2 years as defined by aneurysm exclusion.

  10. Secondary Effectiveness Assessment [ Time Frame: 3 years. ]
    Proportion of subjects treated with the device that achieve and maintain treatment success at 3 years as defined by aneurysm exclusion.

  11. Secondary Effectiveness Assessment [ Time Frame: 4 years. ]
    Proportion of subjects treated with the device that achieve and maintain treatment success at 4 years as define by aneurysm exclusion.

  12. Secondary Effectiveness Assessment [ Time Frame: 5 years. ]
    Proportion of subjects treated with the device that achieve and maintain treatment success at 5 years as define by aneurysm exclusion.



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:

  • A patient may be entered into the study if the patient has at least one of the following:
  • An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
  • Aneurysm with a history of growth > 0.5 cm in 6 months
  • Saccular aneurysm deemed at significant risk for rupture
  • Symptomatic aneurysm greater than 4.5 cm
  • Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
  • Proximal landing zone for the thoracic bifurcation stent graft that has:

    • ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
    • Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold
    • Minimum branch vessel diameter greater than 5 mm
    • Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
  • Age: ≥ 18 years old
  • Life expectancy: > 1 year

Exclusion Criteria:

  • Patient is a good candidate for and elects for open surgical repair
  • Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
  • Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
  • Unwilling to comply with the follow-up schedule
  • Inability or refusal to give informed consent by patient or legal representative
  • Patient is pregnant or breastfeeding
  • Patient has a contained rupture
  • Patient has a ruptured aneurysm
  • Patient has a dissection in the portion of the aorta intended to be treated
  • Obstructive stenting of any or all of the visceral vessels
  • Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium) polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.
  • 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
  • Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair
  • Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
  • Systemic or local infection that may increase the risk of endovascular graft infection
  • Baseline creatinine greater than 2.0 mg/dL
  • History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)

Anatomical exclusion criteria:

  • Thrombus or excessive calcification within the neck of the aneurysm
  • Anatomy that would not allow maintenance of at least one patent hypogastric artery
  • Anatomy that would not allow primary or assisted patency of the left subclavian artery

These will be determined by standard of care assessments of their disease/aneurysm morphology by the treating investigator.


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): NCT03113383


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Medtronic
Investigators
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Principal Investigator: Thomas C Naslund, MD Chief, Division of Vascular Surgery

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Responsible Party: Thomas Naslund, Professor Vascular Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03113383     History of Changes
Other Study ID Numbers: 161627
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data collected will include patient demographics, medical history, current health status, physical examinations, Ankle Brachial Index, pregnancy test results, relevant vessel diameters for determining compatibility with the TAAA Debranching Stent Graft System, all relevant lab values, and all other relevant data abstracted from procedure and follow-up notes. All data will be entered into the web-based data entry forms. Individual case report forms will be kept at each site as source documents, as well as applicable medical records, and will be stored in a locked office within a secure research facility. Subjects will be given coded identifiers so that their names will not be included in the data analysis and storage. All efforts, within reason, will be made to keep subject's protected health information (PHI) private. Using or sharing ("disclosure") such data must follow federal privacy rules.

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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: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Thomas Naslund, Vanderbilt University Medical Center:
Thoracoabdominal Aortic Aneurysm
Endovascular Aneurysm Repair
Stent-Graft

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