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

Primary Purpose

Juxtarenal Aortic Aneurysm, Suprarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cook Custom Aortic Endograft
Zenith t-Branch Endovascular Graft
Surgeon-Modified Endograft
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juxtarenal Aortic Aneurysm focused on measuring Endovascular, Aortic, Aneurysm, Thoracoabdominal, Juxtarenal, Suprarenal, Endograft, Fenestrated, Branched, Complex, Abdominal, Thoracic, Stent, Stentgraft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cook Custom Aortic Endograft

Zenith t-Branch Endovascular Graft

Surgeon-Modified Endograft

Arm Description

Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or 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 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.

Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or 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.

Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the design of the Surgeon-Modified Endografts. These will be created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device 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.

Outcomes

Primary Outcome Measures

Rate of major adverse events at 30 days post primary procedure

Secondary Outcome Measures

Rate of all-cause mortality in peri-operative period
Rate of all-cause mortality at 30 days post primary procedure
Number of major adverse events at 6 months post primary procedure
Number of subjects requiring ventilation more than 48 hours in peri-operative period
Average length of ventilation past 48 hours in peri-operative period
Number of subjects requiring reintubation in peri-operative period
Average ICU length of stay in peri-operative period
Number of patients who underwent tracheostomy to treat pulmonary failure at 30 days post primary procedure
Number of patients who developed postoperative pneumonia at 30 days post primary procedure
Number of patent treated branch vessels at 30 days post primary procedure
Number of patients with loss of device integrity at 30 days post primary procedure
Freedom from reintervention at 30 days post primary procedure
Number of subjects that achieve treatment success at 12 months post procedure
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
Number of major adverse events at 2 years post primary procedure
Number of major adverse events at 3 years post primary procedure
Number of major adverse events at 4 years post primary procedure
Number of major adverse events at 5 years post primary procedure
Number of patients who underwent tracheostomy to treat pulmonary failure at 6 months post primary procedure
Number of patients who underwent tracheostomy to treat pulmonary failure at 12 months post primary procedure
Number of patients who developed postoperative pneumonia at 6 months post primary procedure
Number of patients who developed postoperative pneumonia at 12 months post primary procedure
Number of patent treated branch vessels at 6 months post primary procedure
Number of patent treated branch vessels at 12 months post primary procedure
Number of patent treated branch vessels at 2 years post primary procedure
Number of patent treated branch vessels at 3 years post primary procedure
Number of patent treated branch vessels at 4 years post primary procedure
Number of patent treated branch vessels at 5 years post primary procedure
Number of patients with loss of device integrity at 6 months post primary procedure
Number of patients with loss of device integrity at 12 months post primary procedure
Number of patients with loss of device integrity at 2 years post primary procedure
Number of patients with loss of device integrity at 3 years post primary procedure
Number of patients with loss of device integrity at 4 years post procedure
Number of patients with loss of device integrity at 5 years post primary procedure
Freedom from reintervention at 6 months post primary procedure
Freedom from reintervention at 12 months post primary procedure
Freedom from reintervention at 2 years post primary procedure
Freedom from reintervention at 3 years post primary procedure
Freedom from reintervention at 4 years post primary procedure
Freedom from reintervention at 5 years post primary procedure
Number of major adverse events at 30 days post primary procedure

Full Information

First Posted
January 21, 2014
Last Updated
January 4, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02043691
Brief Title
Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies
Official Title
Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal and Thoracoabdominal Aortic Pathologies Using the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft and Surgeon-Modified Endografts
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Cook Group Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of aortic pathologies involving the visceral vessels. The three 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.
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), Abdominal Device X-ray, and Angiography. The participants will be followed for 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juxtarenal Aortic Aneurysm, Suprarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Penetrating Aortic Ulcer
Keywords
Endovascular, Aortic, Aneurysm, Thoracoabdominal, Juxtarenal, Suprarenal, Endograft, Fenestrated, Branched, Complex, Abdominal, Thoracic, Stent, Stentgraft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cook Custom Aortic Endograft
Arm Type
Experimental
Arm Description
Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or 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 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.
Arm Title
Zenith t-Branch Endovascular Graft
Arm Type
Experimental
Arm Description
Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or 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.
Arm Title
Surgeon-Modified Endograft
Arm Type
Experimental
Arm Description
Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the design of the Surgeon-Modified Endografts. These will be created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device 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.
Intervention Type
Device
Intervention Name(s)
Cook Custom Aortic Endograft
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Zenith t-Branch Endovascular Graft
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Surgeon-Modified Endograft
Intervention Description
The Surgeon-Modified Endografts are created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device 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.
Primary Outcome Measure Information:
Title
Rate of major adverse events at 30 days post primary procedure
Time Frame
30 days post primary procedure
Secondary Outcome Measure Information:
Title
Rate of all-cause mortality in peri-operative period
Time Frame
Peri-operative
Title
Rate of all-cause mortality at 30 days post primary procedure
Time Frame
30 days post primary procedure
Title
Number of major adverse events at 6 months post primary procedure
Time Frame
6 months post primary procedure
Title
Number of subjects requiring ventilation more than 48 hours in peri-operative period
Time Frame
Peri-operative
Title
Average length of ventilation past 48 hours in peri-operative period
Time Frame
Peri-operative
Title
Number of subjects requiring reintubation in peri-operative period
Time Frame
Peri-operative
Title
Average ICU length of stay in peri-operative period
Time Frame
Peri-operative
Title
Number of patients who underwent tracheostomy to treat pulmonary failure at 30 days post primary procedure
Time Frame
30 days post primary procedure
Title
Number of patients who developed postoperative pneumonia at 30 days post primary procedure
Time Frame
30 days post primary procedure
Title
Number of patent treated branch vessels at 30 days post primary procedure
Time Frame
30 days post primary procedure
Title
Number of patients with loss of device integrity at 30 days post primary procedure
Time Frame
30 days post primary procedure
Title
Freedom from reintervention at 30 days post primary procedure
Time Frame
30 days post primary procedure
Title
Number of subjects that achieve treatment success at 12 months post procedure
Description
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.
Time Frame
12 months post procedure
Title
Number of major adverse events at 12 months post procedure
Time Frame
12 months post primary procedure
Title
Number of major adverse events at 2 years post primary procedure
Time Frame
2 years post primary procedure
Title
Number of major adverse events at 3 years post primary procedure
Time Frame
3 years post primary procedure
Title
Number of major adverse events at 4 years post primary procedure
Time Frame
4 years post primary procedure
Title
Number of major adverse events at 5 years post primary procedure
Time Frame
5 years post primary procedure
Title
Number of patients who underwent tracheostomy to treat pulmonary failure at 6 months post primary procedure
Time Frame
6 months post primary procedure
Title
Number of patients who underwent tracheostomy to treat pulmonary failure at 12 months post primary procedure
Time Frame
12 months post primary procedure
Title
Number of patients who developed postoperative pneumonia at 6 months post primary procedure
Time Frame
6 months post primary procedure
Title
Number of patients who developed postoperative pneumonia at 12 months post primary procedure
Time Frame
12 months post primary procedure
Title
Number of patent treated branch vessels at 6 months post primary procedure
Time Frame
6 months post primary procedure
Title
Number of patent treated branch vessels at 12 months post primary procedure
Time Frame
12 months post primary procedure
Title
Number of patent treated branch vessels at 2 years post primary procedure
Time Frame
2 years post primary procedure
Title
Number of patent treated branch vessels at 3 years post primary procedure
Time Frame
3 years post primary procedure
Title
Number of patent treated branch vessels at 4 years post primary procedure
Time Frame
4 years post primary procedure
Title
Number of patent treated branch vessels at 5 years post primary procedure
Time Frame
5 years post primary procedure
Title
Number of patients with loss of device integrity at 6 months post primary procedure
Time Frame
6 months post primary procedure
Title
Number of patients with loss of device integrity at 12 months post primary procedure
Time Frame
12 months post primary procedure
Title
Number of patients with loss of device integrity at 2 years post primary procedure
Time Frame
2 years post primary procedure
Title
Number of patients with loss of device integrity at 3 years post primary procedure
Time Frame
3 years post primary procedure
Title
Number of patients with loss of device integrity at 4 years post procedure
Time Frame
4 years post procedure
Title
Number of patients with loss of device integrity at 5 years post primary procedure
Time Frame
5 years post primary procedure
Title
Freedom from reintervention at 6 months post primary procedure
Time Frame
6 months post primary procedure
Title
Freedom from reintervention at 12 months post primary procedure
Time Frame
12 months post primary procedure
Title
Freedom from reintervention at 2 years post primary procedure
Time Frame
2 years post primary procedure
Title
Freedom from reintervention at 3 years post primary procedure
Time Frame
3 years post primary procedure
Title
Freedom from reintervention at 4 years post primary procedure
Time Frame
4 years post primary procedure
Title
Freedom from reintervention at 5 years post primary procedure
Time Frame
5 years post primary procedure
Title
Number of major adverse events at 30 days post primary procedure
Time Frame
30 days post primary procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Juxtarenal, suprarenal and thoracoabdominal aortic pathology as follows in hemodynamically stable patients: Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximation to the visceral segment of the aorta. Diameter >5.5 cm if asymptomatic, or 5.0 cm with enlargement of >0.5cm in 6 months. History of growth >0.5 cm per year Any size if ruptured or symptomatic Penetrating aortic ulcer (PAU) >2.0cm in depth 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam W Beck, MD
Email
awbeck@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca St John
Email
rstjohn@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam W Beck, MD
Organizational Affiliation
University of Alabama at Bimingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam W Beck, MD
Phone
205-934-2006
Email
awbeck@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Rebecca St. John, MS
Phone
205-934-7279
Email
rstjohn@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Adam W Beck, MD

12. IPD Sharing Statement

Learn more about this trial

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

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