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Trial record 1 of 2 for:    03111459
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Repair of Thoracoabdominal Aortic Aneurysms

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ClinicalTrials.gov Identifier: NCT03111459
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Geoffrey Answini, The Christ Hospital

Brief Summary:
The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Condition or disease Intervention/treatment Phase
Thoracoabdominal Aneurysm Device: Medtronic Valiant Thoracoabdominal Stent Graft System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primary Study Arm
Patients meeting primary inclusion/exclusion criteria will be enrolled in this arm and treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.
Device: Medtronic Valiant Thoracoabdominal Stent Graft System
The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components The system is comprised of two investigational devices that include the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.

Experimental: Expanded Selection Arm
Patients who fail to meet the inclusion criteria of the Primary Study Arm may be enrolled under the Expanded Selection Arm and be treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.
Device: Medtronic Valiant Thoracoabdominal Stent Graft System
The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components The system is comprised of two investigational devices that include the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.




Primary Outcome Measures :
  1. Proportion of subjects free from major adverse events [ Time Frame: 30 days ]
    major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.


Secondary Outcome Measures :
  1. Treatment Success at follow-up intervals [ Time Frame: 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
    Treatment success includes freedom from: aneurysm enlargement, aneurysm related mortality, aneurysm rupture, conversion to open repair, secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency related events, renal failure, all-cause mortality, endoleaks, device integrity failure, patency related events and other device related events.



Information from the National Library of Medicine

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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. A patient may be entered into the study if the patient has at least one of the following:

    1. 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
    2. aneurysm with a history of growth > 0.5 cm in 6 months
    3. saccular aneurysm deemed at significant risk for rupture
    4. symptomatic aneurysm greater than 4.5 cm
  2. 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.
  3. Proximal landing zone for the thoracic bifurcation stent graft that has:

    1. ≥ 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.
    2. 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.
  4. Minimum branch vessel diameter ≥ 5 mm.
  5. 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.
  6. Patient is ≥ 18 years of age.
  7. Patient has a life expectancy > 1 year.

Exclusion Criteria:

  1. Patient is a good candidate for and elects open surgical repair.
  2. Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.
  3. Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.
  4. Patient is unwilling to comply with the follow-up schedule.
  5. Patient is unable or refuses to give informed consent.
  6. Urgent or emergent presentation.
  7. Patient is pregnant or breastfeeding.
  8. Patient has a contained rupture.
  9. Patient has a ruptured aneurysm.
  10. Patient has a dissection in the treated portion of the aorta.
  11. Obstructive stenting of any or all of the visceral vessels.
  12. Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).

Medical Exclusion Criteria:

  1. Patient has 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.
  2. Patient has known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
  3. Patient has an uncorrectable coagulopathy.
  4. Patient has a body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.
  5. Patient has had a major surgical or interventional procedure. unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair.
  6. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina).
  7. Patient has a systemic or local infection that may increase the risk of endovascular graft infection.
  8. Baseline creatinine greater than 2.0 mg/dL.
  9. History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome).

Anatomical Exclusion Criteria:

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

Expanded Selection Criteria:

Subjects who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded selection arm if they meet the following criteria.

Inclusion Criteria:

  1. Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm:

    1. Patient has a minimum branch vessel diameter less than 5 mm.
    2. Patients presents urgently or emergently.
    3. Patient has a contained rupture.
    4. Patient has a ruptured aneurysm.
    5. Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated.
    6. Patient has poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular).
    7. Patient's baseline creatinine greater than 2.0 mg/dL.
    8. Patient's anatomy that would not allow for maintenance of at least one hypogastric artery.
    9. Patient's anatomy that would not allow for primary or assisted patency of the left subclavian artery.

    Or

  2. Patient that meets the criteria for inclusion in the primary study arm and:

    1. Would not be eligible for the primary study arm per a documented reason other than those outlined above, and
    2. Per the opinion of the Principal Investigator, with concurrence of the IRB, alternative therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.

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): NCT03111459


Contacts
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Contact: Geoffrey Answini, MD 513-585-1777 geoffrey.answini@thechristhospital.com
Contact: Darlene Rock 513-585-1777 darlene.rock@thechristhospital.com

Locations
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United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Geoffrey Answini, MD    513-585-1777      
Contact: Darlene Rock, RN,MBA    513-585-1777    darlene.rock@thechristhospital.com   
Sponsors and Collaborators
The Christ Hospital
Medtronic
Investigators
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Principal Investigator: Geoffrey Answini, MD The Christ Hospital
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Responsible Party: Geoffrey Answini, Dr., The Christ Hospital
ClinicalTrials.gov Identifier: NCT03111459    
Other Study ID Numbers: ISR-2016-10790
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
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
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Geoffrey Answini, The Christ Hospital:
endograft repair,
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases