Trial record 5 of 135 for:    Open Studies | "Aortic Aneurysm"

Evaluation of the Cook Custom Aortic Endograft and the Zenith t-Branch Endovascular Graft in Treating Aortic Pathologies

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Florida
Sponsor:
Collaborator:
Cook
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02043691
First received: January 21, 2014
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

This is a single-center study to evaluate the safety and effectiveness of two investigational devices, the Cook Custom Aortic Endograft and the Zenith t-Branch Endovascular Graft, in the treatment of aortic pathologies involving the visceral vessels.

The two investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.


Condition Intervention Phase
Juxtarenal Aortic Aneurysm
Suprarenal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Penetrating Aortic Ulcer
Device: Cook Custom Aortic Endograft
Device: Zenith t-Branch Endovascular Graft
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal and Thoracoabdominal Aortic Pathologies Using the Cook Custom Aortic Endograft and the Zenith t-Branch Endovascular Graft

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Rate of major adverse events at 30 days post primary procedure [ Time Frame: 30 days post primary procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of all-cause mortality in peri-operative period [ Time Frame: Peri-operative ] [ Designated as safety issue: Yes ]
  • Rate of all-cause mortality at 30 days post primary procedure [ Time Frame: 30 days post primary procedure ] [ Designated as safety issue: Yes ]
  • Number of major adverse events at 6 months post primary procedure [ Time Frame: 6 months post primary procedure ] [ Designated as safety issue: Yes ]
  • Number of subjects requiring ventilation more than 48 hours in peri-operative period [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
  • Average length of ventilation past 48 hours in peri-operative period [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
  • Number of subjects requiring reintubation in peri-operative period [ Time Frame: Peri-operative ] [ Designated as safety issue: Yes ]
  • Average ICU length of stay in peri-operative period [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
  • Number of patients who underwent tracheostomy to treat pulmonary failure at 30 days post primary procedure [ Time Frame: 30 days post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients who developed postoperative pneumonia at 30 days post primary procedure [ Time Frame: 30 days post primary procedure ] [ Designated as safety issue: No ]
  • Number of patent treated branch vessels at 30 days post primary procedure [ Time Frame: 30 days post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients with loss of device integrity at 30 days post primary procedure [ Time Frame: 30 days post primary procedure ] [ Designated as safety issue: No ]
  • Freedom from reintervention at 30 days post primary procedure [ Time Frame: 30 days post primary procedure ] [ Designated as safety issue: No ]
  • Number of subjects that achieve treatment success at 12 months post procedure [ Time Frame: 12 months post procedure ] [ Designated as safety issue: No ]

    Treatment success is defined as procedural technical success and patent treated branch vessels at 12 months post procedure, device integrity, and freedom from both reintervention and aortic enlargement ≤5mm as compared to baseline at 12 months post primary procedure.

    Technical success is defined as successful exclusion of the diseased aortic segment without a clinically significant type I or type III endoleak and patent treated branch vessels at the end of the procedure without the need for unanticipated corrective interventions.


  • Number of major adverse events at 12 months post procedure [ Time Frame: 12 months post primary procedure ] [ Designated as safety issue: Yes ]
  • Number of major adverse events at 2 years post primary procedure [ Time Frame: 2 years post primary procedure ] [ Designated as safety issue: Yes ]
  • Number of major adverse events at 3 years post primary procedure [ Time Frame: 3 years post primary procedure ] [ Designated as safety issue: Yes ]
  • Number of major adverse events at 4 years post primary procedure [ Time Frame: 4 years post primary procedure ] [ Designated as safety issue: Yes ]
  • Number of major adverse events at 5 years post primary procedure [ Time Frame: 5 years post primary procedure ] [ Designated as safety issue: Yes ]
  • Number of patients who underwent tracheostomy to treat pulmonary failure at 6 months post primary procedure [ Time Frame: 6 months post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients who underwent tracheostomy to treat pulmonary failure at 12 months post primary procedure [ Time Frame: 12 months post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients who developed postoperative pneumonia at 6 months post primary procedure [ Time Frame: 6 months post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients who developed postoperative pneumonia at 12 months post primary procedure [ Time Frame: 12 months post primary procedure ] [ Designated as safety issue: No ]
  • Number of patent treated branch vessels at 6 months post primary procedure [ Time Frame: 6 months post primary procedure ] [ Designated as safety issue: No ]
  • Number of patent treated branch vessels at 12 months post primary procedure [ Time Frame: 12 months post primary procedure ] [ Designated as safety issue: No ]
  • Number of patent treated branch vessels at 2 years post primary procedure [ Time Frame: 2 years post primary procedure ] [ Designated as safety issue: No ]
  • Number of patent treated branch vessels at 3 years post primary procedure [ Time Frame: 3 years post primary procedure ] [ Designated as safety issue: No ]
  • Number of patent treated branch vessels at 4 years post primary procedure [ Time Frame: 4 years post primary procedure ] [ Designated as safety issue: No ]
  • Number of patent treated branch vessels at 5 years post primary procedure [ Time Frame: 5 years post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients with loss of device integrity at 6 months post primary procedure [ Time Frame: 6 months post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients with loss of device integrity at 12 months post primary procedure [ Time Frame: 12 months post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients with loss of device integrity at 2 years post primary procedure [ Time Frame: 2 years post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients with loss of device integrity at 3 years post primary procedure [ Time Frame: 3 years post primary procedure ] [ Designated as safety issue: No ]
  • Number of patients with loss of device integrity at 4 years post procedure [ Time Frame: 4 years post procedure ] [ Designated as safety issue: No ]
  • Number of patients with loss of device integrity at 5 years post primary procedure [ Time Frame: 5 years post primary procedure ] [ Designated as safety issue: No ]
  • Freedom from reintervention at 6 months post primary procedure [ Time Frame: 6 months post primary procedure ] [ Designated as safety issue: No ]
  • Freedom from reintervention at 12 months post primary procedure [ Time Frame: 12 months post primary procedure ] [ Designated as safety issue: No ]
  • Freedom from reintervention at 2 years post primary procedure [ Time Frame: 2 years post primary procedure ] [ Designated as safety issue: No ]
  • Freedom from reintervention at 3 years post primary procedure [ Time Frame: 3 years post primary procedure ] [ Designated as safety issue: No ]
  • Freedom from reintervention at 4 years post primary procedure [ Time Frame: 4 years post primary procedure ] [ Designated as safety issue: No ]
  • Freedom from reintervention at 5 years post primary procedure [ Time Frame: 5 years post primary procedure ] [ Designated as safety issue: No ]
  • Number of major adverse events at 30 days post primary procedure [ Time Frame: 30 days post primary procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2014
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cook Custom Aortic Endograft
Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast), Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the design of the Cook Custom Aortic Endograft. The Cook Custom Aortic Endograft is has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.
Device: Cook Custom Aortic Endograft
The Cook Custom Aortic Endograft has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.
Experimental: Zenith t-Branch Endovascular Graft
Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast), Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the sizing of the the Zenith t-Branch Endovascular Graft. The Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents.
Device: Zenith t-Branch Endovascular Graft
The Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents.

Detailed Description:

Once the participant has signed the approved informed consent the following tests will be done to determine final subject eligibility and which device will be used:

Clinical Exam, Blood Tests, CT Scans (with and without contrast), Ultrasound, Abdominal Device X-ray, and Angiography.

The participants will be followed for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Juxtarenal, suprarenal and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:

    1. Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximation to the visceral segment of the aorta.

      1. Diameter >5.5 cm if asymptomatic, or 5.0 cm with enlargement of >0.5cm in 6 months.
      2. History of growth >0.5 cm per year
      3. Any size if ruptured or symptomatic
    2. Penetrating aortic ulcer (PAU)

      1. >2.0cm in depth
      2. Any size if contained ruptured or symptomatic

General Exclusion Criteria:

  • Less than 18 years of age
  • Life expectancy less than 12 months based on the surgeon's assessment
  • Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  • Inability or refusal to give informed consent
  • Unwilling or unable to comply with the follow-up schedule
  • Less than 30 days beyond primary endpoint for other investigative drug or device study

Medical Exclusion Criteria:

  • Known allergy to the device components (i.e. stainless steel, polyester, solder, gold, or nitinol)
  • History of anaphylactic reaction to contrast material that cannot be adequately premedicated
  • Systemic or local infection that may increase the risk of endovascular graft infection.
  • Baseline eGFR <30mL/min (calculated by the Modification of Diet in Renal Disease formula) and not on hemo- or peritoneal dialysis. If the patient is currently on dialysis, or is currently planning on initiating dialysis, then they may undergo repair.
  • History of connective tissue disorders.
  • Body habitus that would inhibit X-ray visualization of the aorta.
  • Major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.
  • Unstable angina, defined as a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina.
  • Irreversible coagulopathy

Anatomical Exclusion Criteria:

  • Aortic transection due to acute trauma.
  • Aortic dissection.
  • Infectious ("mycotic") etiology of the aortic disease.
  • Significant occlusive disease or tortuosity precluding delivery of the device components.
  • Proximal Landing zone <20mm in length. The proximal landing zone can be within zones 2 through 8, with least 20mm of proximal seal and fixation in aorta or Dacron.
  • Proximal neck, defined as the thoracic aorta distal to the native left carotid artery, measured outer wall to outer wall on a sectional image (CT) >41 mm in diameter or < 18 mm in diameter
  • Distal landing zone <20mm in length if the landing zone is in the aorta, or <20mm if the landing zone is in the iliac arteries or in Dacron (in the event the patient has had a previous or concomitant aortic or aorto-iliac reconstruction).
  • Untreatable branch vessel stenosis.
  • Anatomy that would not allow maintenance of at least one patent hypogastric artery.
  • Signs that the inferior mesenteric artery is indispensable (i.e. angiographic visualization or a large IMA, filling of SMA via collaterals, stenosis of celiac or SMA or oblique views) and the indispensible IMA is not amenable to treatment with a graft branch or fenestration.
  • Branching, duplication, aneurysm or untreatable stenosis of the celiac, SMA or renal arteries that would preclude implantation of the investigational devices.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043691

Contacts
Contact: Adam W Beck, MD 352-273-5484 Adam.Beck@surgery.ufl.edu
Contact: Vida R Sollanek, BA 352-273-7883 Vida.Sollanek@surgery.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Adam W Beck, MD    352-273-5484    Adam.Beck@surgery.ufl.edu   
Contact: Vida R Sollanek, BA    352-273-7883    Vida.Sollanek@surgery.ufl.edu   
Principal Investigator: Adam W Beck, MD         
Sponsors and Collaborators
University of Florida
Cook
Investigators
Principal Investigator: Adam W Beck, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02043691     History of Changes
Other Study ID Numbers: 201400001
Study First Received: January 21, 2014
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Florida:
Endovascular
Aortic
Aneurysm
Thoracoabdominal
Juxtarenal
Suprarenal
Endograft
Fenestrated
Branched
Complex
Abdominal
Thoracic
Stent
Stentgraft

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

ClinicalTrials.gov processed this record on August 21, 2014