Aortic Arch Aneurysm, Aortic Dissection, Juxtarenal Aortic Aneurysm, Penetrating Aortic Ulcer, Suprarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Conditions
Keywords
Endovascular, Aortic, Aneurysm, Thoracoabdominal, Juxtarenal, Suprarenal, Endograft, Fenestrated, Branched, Complex, Abdominal, Thoracic, Stent, Stentgraft, Arch, Ascending, Dissection, Descending
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 Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or 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
Described as follows: Juxtarenal, Suprarenal, Thoracoabdominal aortic pathologies involving at least one visceral artery. Aortic Arch pathologies involving the at least one brachiocephalic artery. 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: Juxtarenal, Suprarenal, Thoracoabdominal: Clinical Exam, Blood Tests, CT Scans (with and without contrast), Abdominal Device X-ray, and Angiography. Aortic Arch: Clinical Exam, Neurological Exam, Blood Tests, Echocardiogram, CT Scans (with and without contrast), Chest X-ray, and Angiography. The participants will be followed for 5 years.
Interventions
DEVICECook 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 aorta, thoracoabdominal aorta, or the aortic arch aorta. Grafts may include a combination of up to 5 fenestrations and/or branches.
DEVICEZenith 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.
DEVICESurgeon-Modified Endograft
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.
Sponsors
Cook Group Incorporated
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \> 0.5 cm 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. \> 2.0 cm in depth 2. Any size if contained ruptured or symptomatic 3. Subacute (\>14 days) or chronic (\>20 days) aortic dissection with aneurysmal degeneration with at least one of the following: 1. Total aortic diameter \> 5.5 cm if asymptomatic 2. Total aortic diameter \> 4.5 cm if symptomatic 3. Total aortic diameter \> 5.0 cm and history of growth \> 0.5 cm in 6 months * Aortic Arch pathology: 1. Aneurysm, Ascending thoracic aortic pseudoaneurysm, Type A thoracic aortic dissection, Retrograde type A thoracic aortic dissection between the Sinus of Valsalva and the innominate artery orifice (without involvement of the Aortic Valve), or Ascending penetrating aortic ulcer with and without intramural hematoma 2. Suitable iliac artery and brachial artery access 3. Absence of severe landing zone (\> 90 degree) angulation that would preclude necessary device delivery/seal/fixation. 4. Suitable iliac artery access to accommodate device delivery system. 5. Target arteries for arch branches: 1. \< 24 mm diameter 2. Adequate landing zone length to obtain proximal and distal seal. 3. Free from dissection precluding adequate seal in distal landing zone of branch stent and severe tortuosity/thrombus/calcification. * Aortic Arch Aneurysm 1. Proximal aortic fixation zone: 1. Native aorta or surgical graft 2. Diameter: 20 - 42 mm 2. Proximal neck length \> 20 mm 3. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion. 4. Distal aortic fixation zone: 1. Native aorta or surgical graft 2. Diameter: 20 - 44 mm 5. Distal neck length \> 20 mm. However, if dissection, distal graft may land in dissected aorta. 6. Supra-aortic trunk (brachiocephalic) vessels (Any combination of arteries may be used for repair) A. Innominate artery 1. Native vessel or surgical graft 2. Diameter: 8 - 22 mm 3. Length of sealing zone \> 10 mm 4. Acceptable tortuosity B. Left (or right) common carotid artery <!-- --> 1. Native vessel or surgical graft 2. Diameter 5 - 20 mm 3. Length of sealing zone \> 10 mm C. Left (or right) subclavian artery <!-- --> 1. Native vessel or surgical graft 2. Diameter 5 - 20 mm 3. Length of sealing zone \> 10 mm * Aortic Dissection 1. Access into the true lumen from the groin and at least one supra-aortic trunk vessel. 2. Seal zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen. 3. Seal zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen or surgically created. 4. True lumen size large enough to deploy the device and still gain access into the target branch. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of major adverse events at 30 days post primary procedure | 30 days post primary procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all-cause mortality at 30 days post primary procedure | 30 days post primary procedure | — |
| Number of major adverse events at 6 months post primary procedure | 6 months post primary procedure | — |
| Number of subjects requiring ventilation more than 48 hours in peri-operative period | Peri-operative | — |
| Average length of ventilation past 48 hours in peri-operative period | Peri-operative | — |
| Number of subjects requiring reintubation in peri-operative period | Peri-operative | — |
| Average ICU length of stay in peri-operative period | Peri-operative | — |
| Number of patients who underwent tracheostomy to treat pulmonary failure at 30 days post primary procedure | 30 days post primary procedure | — |
| Number of patients who developed postoperative pneumonia at 30 days post primary procedure | 30 days post primary procedure | — |
| Number of patent treated branch vessels at 30 days post primary procedure | 30 days post primary procedure | — |
| Number of patients with loss of device integrity at 30 days post primary procedure | 30 days post primary procedure | — |
| Freedom from reintervention at 30 days post primary procedure | 30 days post primary procedure | — |
| Number of subjects that achieve treatment success at 12 months post procedure | 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 | 12 months post primary procedure | — |
| Number of major adverse events at 2 years post primary procedure | 2 years post primary procedure | — |
| Number of major adverse events at 3 years post primary procedure | 3 years post primary procedure | — |
| Number of major adverse events at 4 years post primary procedure | 4 years post primary procedure | — |
| Number of major adverse events at 5 years post primary procedure | 5 years post primary procedure | — |
| Number of patients who underwent tracheostomy to treat pulmonary failure at 6 months post primary procedure | 6 months post primary procedure | — |
| Number of patients who underwent tracheostomy to treat pulmonary failure at 12 months post primary procedure | 12 months post primary procedure | — |
| Number of patients who developed postoperative pneumonia at 6 months post primary procedure | 6 months post primary procedure | — |
| Number of patients who developed postoperative pneumonia at 12 months post primary procedure | 12 months post primary procedure | — |
| Number of patent treated branch vessels at 6 months post primary procedure | 6 months post primary procedure | — |
| Number of patent treated branch vessels at 12 months post primary procedure | 12 months post primary procedure | — |
| Number of patent treated branch vessels at 2 years post primary procedure | 2 years post primary procedure | — |
| Number of patent treated branch vessels at 3 years post primary procedure | 3 years post primary procedure | — |
| Number of patent treated branch vessels at 4 years post primary procedure | 4 years post primary procedure | — |
| Number of patent treated branch vessels at 5 years post primary procedure | 5 years post primary procedure | — |
| Number of patients with loss of device integrity at 6 months post primary procedure | 6 months post primary procedure | — |
| Number of patients with loss of device integrity at 12 months post primary procedure | 12 months post primary procedure | — |
| Number of patients with loss of device integrity at 2 years post primary procedure | 2 years post primary procedure | — |
| Number of patients with loss of device integrity at 3 years post primary procedure | 3 years post primary procedure | — |
| Number of patients with loss of device integrity at 4 years post procedure | 4 years post procedure | — |
| Number of patients with loss of device integrity at 5 years post primary procedure | 5 years post primary procedure | — |
| Freedom from reintervention at 6 months post primary procedure | 6 months post primary procedure | — |
| Freedom from reintervention at 12 months post primary procedure | 12 months post primary procedure | — |
| Freedom from reintervention at 2 years post primary procedure | 2 years post primary procedure | — |
| Freedom from reintervention at 3 years post primary procedure | 3 years post primary procedure | — |
| Freedom from reintervention at 4 years post primary procedure | 4 years post primary procedure | — |
| Freedom from reintervention at 5 years post primary procedure | 5 years post primary procedure | — |
| Number of major adverse events at 30 days post primary procedure | 30 days post primary procedure | — |
| Rate of neurologic morbidity in peri-operative period | Peri-operative | — |
| Rate of neurologic morbidity at hospital discharge | Peri-operative | — |
| Rate of neurologic morbidity at 30 days post primary procedure | 30 days post primary procedure | — |
| Rate of neurologic morbidity at 6 months post primary procedure | 6 months post primary procedure | — |
| Rate of all-cause mortality in peri-operative period | Peri-operative | — |
| Rate of neurologic morbidity at 1 year post primary procedure | 1 year post primary procedure | — |
| Rate of neurologic morbidity at 2 year post primary procedure | 2 year post primary procedure | — |
| Rate of neurologic morbidity at 3 year post primary procedure | 3 year post primary procedure | — |
| Rate of neurologic morbidity at 4 year post primary procedure | 4 year post primary procedure | — |
| Rate of neurologic morbidity at 5 year post primary procedure | 5 year post primary procedure | — |
| Rate of neurologic morbidity at 12 months post primary procedure | 12 months post primary procedure | — |
Countries
United States
Contacts
Primary ContactAdam W Beck, MD
Backup ContactRebecca St John
Outcome results
None listed