Clinical trial NCT02043691: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Cook Group Incorporated
First posted: 2014-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Rate of major adverse events at 30 days post primary procedure
timeFrame: 30 days post primary procedure
Secondary outcomes:
measure: Rate of all-cause mortality in peri-operative period
timeFrame: Peri-operative
measure: Rate of all-cause mortality at 30 days post primary procedure
timeFrame: 30 days post primary procedure
measure: Number of major adverse events at 6 months post primary procedure
timeFrame: 6 months post primary procedure
measure: Number of subjects requiring ventilation more than 48 hours in peri-operative period
timeFrame: Peri-operative
measure: Average length of ventilation past 48 hours in peri-operative period
timeFrame: Peri-operative
measure: Number of subjects requiring reintubation in peri-operative period
timeFrame: Peri-operative
measure: Average ICU length of stay in peri-operative period
timeFrame: Peri-operative
measure: Number of patients who underwent tracheostomy to treat pulmonary failure at 30 days post primary procedure
timeFrame: 30 days post primary procedure
measure: Number of patients who developed postoperative pneumonia at 30 days post primary procedure
timeFrame: 30 days post primary procedure
measure: Number of patent treated branch vessels at 30 days post primary procedure
timeFrame: 30 days post primary procedure
measure: Number of patients with loss of device integrity at 30 days post primary procedure
timeFrame: 30 days post primary procedure
measure: Freedom from reintervention at 30 days post primary procedure
timeFrame: 30 days post primary procedure
measure: Number of subjects that achieve treatment success at 12 months post procedure
timeFrame: 12 months post procedure
measure: Number of major adverse events at 12 months post procedure
timeFrame: 12 months post primary procedure
measure: Number of major adverse events at 2 years post primary procedure
timeFrame: 2 years post primary procedure
measure: Number of major adverse events at 3 years post primary procedure
timeFrame: 3 years post primary procedure
measure: Number of major adverse events at 4 years post primary procedure
timeFrame: 4 years post primary procedure
measure: Number of major adverse events at 5 years post primary procedure
timeFrame: 5 years post primary procedure
measure: Number of patients who underwent tracheostomy to treat pulmonary failure at 6 months post primary procedure
timeFrame: 6 months post primary procedure
measure: Number of patients who underwent tracheostomy to treat pulmonary failure at 12 months post primary procedure
timeFrame: 12 months post primary procedure
measure: Number of patients who developed postoperative pneumonia at 6 months post primary procedure
timeFrame: 6 months post primary procedure
measure: Number of patients who developed postoperative pneumonia at 12 months post primary procedure
timeFrame: 12 months post primary procedure
measure: Number of patent treated branch vessels at 6 months post primary procedure
timeFrame: 6 months post primary procedure
measure: Number of patent treated branch vessels at 12 months post primary procedure
timeFrame: 12 months post primary procedure
measure: Number of patent treated branch vessels at 2 years post primary procedure
timeFrame: 2 years post primary procedure
measure: Number of patent treated branch vessels at 3 years post primary procedure
timeFrame: 3 years post primary procedure
measure: Number of patent treated branch vessels at 4 years post primary procedure
timeFrame: 4 years post primary procedure
measure: Number of patent treated branch vessels at 5 years post primary procedure
timeFrame: 5 years post primary procedure
measure: Number of patients with loss of device integrity at 6 months post primary procedure
timeFrame: 6 months post primary procedure
measure: Number of patients with loss of device integrity at 12 months post primary procedure
timeFrame: 12 months post primary procedure
measure: Number of patients with loss of device integrity at 2 years post primary procedure
timeFrame: 2 years post primary procedure
measure: Number of patients with loss of device integrity at 3 years post primary procedure
timeFrame: 3 years post primary procedure
measure: Number of patients with loss of device integrity at 4 years post procedure
timeFrame: 4 years post procedure
measure: Number of patients with loss of device integrity at 5 years post primary procedure
timeFrame: 5 years post primary procedure
measure: Freedom from reintervention at 6 months post primary procedure
timeFrame: 6 months post primary procedure
measure: Freedom from reintervention at 12 months post primary procedure
timeFrame: 12 months post primary procedure
measure: Freedom from reintervention at 2 years post primary procedure
timeFrame: 2 years post primary procedure
measure: Freedom from reintervention at 3 years post primary procedure
timeFrame: 3 years post primary procedure
measure: Freedom from reintervention at 4 years post primary procedure
timeFrame: 4 years post primary procedure
measure: Freedom from reintervention at 5 years post primary procedure
timeFrame: 5 years post primary procedure
measure: Number of major adverse events at 30 days post primary procedure
timeFrame: 30 days post primary procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Bimingham
name: Adam W Beck, MD
role: PRINCIPAL_INVESTIGATOR
References: