RECRUITING

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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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch Pathologies Using Cook Custom Aortic Endografts, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endograft

Quick Facts

Study Start:2014-06

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02043691

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Adam W Beck, MD

CONTACT

awbeck@uabmc.edu

Rebecca St John

CONTACT

rstjohn@uabmc.edu

Principal Investigator

Adam W Beck, MD

PRINCIPAL_INVESTIGATOR

University of Alabama at Bimingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Adam W Beck, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Bimingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-06

Study Completion Date2027-10

Study Record Updates