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Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

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ClinicalTrials.gov Identifier: NCT03637374
Recruitment Status : Enrolling by invitation
First Posted : August 20, 2018
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE August 10, 2018
First Posted Date  ICMJE August 20, 2018
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE September 8, 2020
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
Freedom from major adverse events (MAEs) at 30 days [ Time Frame: 30 days ]
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
Treatment success at 1 year [ Time Frame: 1 year ]
Treatment success is defined as a composite of technical success and freedom from the following: Aneurysm enlargement, Aneurysm rupture, Aneurysm-related mortality, Conversion to open repair, Secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device
Official Title  ICMJE A Study of the Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device
Brief Summary The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Detailed Description The primary objective of this clinical investigation is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms. While surgery remains a standard treatment for complex abdominal and thoracoabdominal aneurysms (TAAA), the tolerance of some patients to recover from such extensive and invasive open aortic reconstructions is poor. Endovascular repair may offer the opportunity to reduce patient risk with less invasive approaches, improve quality of life, and serve to reduce the cost burden. The primary technical 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 1 year.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thoracoabdominal Aortic Aneurysm
Intervention  ICMJE
  • Device: Visceral Manifold and Thoracic Bifurcation
    Endovascular stent graft system
  • Device: Unitary Manifold
    Endovascular stent graft system
  • Device: TAAA Debranching Stent Graft System
    Endovascular stent graft system
Study Arms  ICMJE
  • Experimental: Primary Study Arm
    The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
    Interventions:
    • Device: Visceral Manifold and Thoracic Bifurcation
    • Device: Unitary Manifold
    • Device: TAAA Debranching Stent Graft System
  • Expanded Selection Arm
    The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
    Interventions:
    • Device: Visceral Manifold and Thoracic Bifurcation
    • Device: Unitary Manifold
    • Device: TAAA Debranching Stent Graft System
Publications * Anderson J, Nykamp M, Danielson L, Remund T, Kelly PW. A novel endovascular debranching technique using physician-assembled endografts for repair of thoracoabdominal aneurysms. J Vasc Surg. 2014 Nov;60(5):1177-1184. doi: 10.1016/j.jvs.2014.05.090. Epub 2014 Jul 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 16, 2018)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Modified 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

Other inclusion criteria:

  • 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 healthy/nondiseased tissue (including previously placed graft material) (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
    • ≥2.5cm of surgical graft distal to the left subclavian artery (LSA) diameter in the range of 26-42mm.
    • 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 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
  • Patency of the four major visceral vessels (SMA, celiac, right renal, left renal)
  • Age: ≥ 18 years old
  • Life expectancy: > 1 year

Exclusion Criteria

General exclusion

  • Patient is a good candidate for and elects 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 investigational device exemption (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 treated portion of the aorta
  • Obstructive stenting of any or all of the visceral vessels

Medical exclusion criteria

  • 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
  • Branch stenosis ≥ 70%
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03637374
Other Study ID Numbers  ICMJE IRB00075706
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James H Black, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP