RECRUITING

Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic

Conditions

Thoracoabdominal Aortic Aneurysm, Without Rupture Thoracoabdominal Aortic Aneurysm Branched vessels

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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

An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms. The study evaluates non-FDA-approved off the shelf and custom made branched and fenestrated-branched stent grafts manufactured by Cook Medical. The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.

Official Title

Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms: an Investigator-Initiated Study

Quick Facts

Study Start:2012-08

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01874197

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
1. Patient is \> 18 years of age 2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study) 3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form 4. Patient is considered by the treating physician to be at high risk of open surgical repair due to one or more major medical co-morbidities (i.e. CAD, CHF, COPD, CRI, advanced age, generalized deconditioning, or other.) with ASA of 3 or more. 5. The patient has a life expectancy of greater than 1 year. 6. The patient has a thoraco-abdominal aortic aneurysm where necessary visceral branch vessels (i.e. the celiac, superior mesenteric, inferior mesenteric, renal and/or dominant spinal arteries) arise from the aneurysm or seal zones necessary for on-label thoracic endovascular repair 7. Patient has a thoraco-abdominal aortic aneurysm that meets at least one of the following: * aneurysm \> 5.5 cm in diameter * aneurysm has increased in size by 0.5 cm in last 6 months * aneurysm is believed to be causing symptoms 8. Patient has sufficient arterial access (femoral and/or iliac) that will allow delivery of the endovascular device with or without the use of a surgical conduit. 9. Patient has suitable proximal (aorta) and distal (aorta or iliac) arteries to allow for adequate fixation and seal: 1. with a length of 25 mm of proximal seal in non-aneurysmal aorta, with or without coverage of the left subclavian artery, 2. with an outer wall diameter of no less than 20 mm and no greater 38mm, and 3. With a length of at least 15 mm, 4. Aortic seal zone no less than 15 mm and no greater than 38 mm or Iliac seal zone with an outer wall diameter of no less than 8 mm and no greater than 23 mm. 10. The patient has no more than 5 necessary visceral arteries that require flow preservation. 11. All target visceral artery seal zones are \> 4 mm in diameter. 12. Patient must be willing to comply with all required follow-up exams.	1. Patient has an active systemic infection 2. Patient has a mycotic aneurysm. 3. Patient has a known hypersensitivity to contrast media that is not amenable to pre-treatment. 4. Patient has an absolute contra-indication to anticoagulation 5. Patient has a known allergy or intolerance to stainless steel, nickel, or gold 6. Patient has a body habitus that would inhibit adequate X-ray visualization of the aorta 7. Patient has a dominant artery to the spinal cord arising from an area of stent graft coverage that is not amenable to preservation using an endovascular branch 8. Patient is currently participating in another investigational device or drug clinical trial 9. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations. 10. Patient has a freely ruptured TAAA with hemodynamic instability 11. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina) 12. Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned within 30 days of the TAAA repair. Adjunctive procedures for treatment of the TAAA (i.e. carotid-subclavian bypass or iliac conduit) are acceptable. 13. Patient has a history of connective tissue disease (e.g. Marfan or Ehlers Danlos syndromes)

Inclusion Criteria

Exclusion Criteria

1. Patient is \> 18 years of age
2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
4. Patient is considered by the treating physician to be at high risk of open surgical repair due to one or more major medical co-morbidities (i.e. CAD, CHF, COPD, CRI, advanced age, generalized deconditioning, or other.) with ASA of 3 or more.
5. The patient has a life expectancy of greater than 1 year.
6. The patient has a thoraco-abdominal aortic aneurysm where necessary visceral branch vessels (i.e. the celiac, superior mesenteric, inferior mesenteric, renal and/or dominant spinal arteries) arise from the aneurysm or seal zones necessary for on-label thoracic endovascular repair
7. Patient has a thoraco-abdominal aortic aneurysm that meets at least one of the following:
* aneurysm \> 5.5 cm in diameter
* aneurysm has increased in size by 0.5 cm in last 6 months
* aneurysm is believed to be causing symptoms
8. Patient has sufficient arterial access (femoral and/or iliac) that will allow delivery of the endovascular device with or without the use of a surgical conduit.
9. Patient has suitable proximal (aorta) and distal (aorta or iliac) arteries to allow for adequate fixation and seal:
1. with a length of 25 mm of proximal seal in non-aneurysmal aorta, with or without coverage of the left subclavian artery,
2. with an outer wall diameter of no less than 20 mm and no greater 38mm, and
3. With a length of at least 15 mm,
4. Aortic seal zone no less than 15 mm and no greater than 38 mm or Iliac seal zone with an outer wall diameter of no less than 8 mm and no greater than 23 mm.
10. The patient has no more than 5 necessary visceral arteries that require flow preservation.
11. All target visceral artery seal zones are \> 4 mm in diameter. 12. Patient must be willing to comply with all required follow-up exams.

1. Patient has an active systemic infection
2. Patient has a mycotic aneurysm.
3. Patient has a known hypersensitivity to contrast media that is not amenable to pre-treatment.
4. Patient has an absolute contra-indication to anticoagulation
5. Patient has a known allergy or intolerance to stainless steel, nickel, or gold
6. Patient has a body habitus that would inhibit adequate X-ray visualization of the aorta
7. Patient has a dominant artery to the spinal cord arising from an area of stent graft coverage that is not amenable to preservation using an endovascular branch
8. Patient is currently participating in another investigational device or drug clinical trial
9. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
10. Patient has a freely ruptured TAAA with hemodynamic instability
11. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
12. Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned within 30 days of the TAAA repair. Adjunctive procedures for treatment of the TAAA (i.e. carotid-subclavian bypass or iliac conduit) are acceptable.
13. Patient has a history of connective tissue disease (e.g. Marfan or Ehlers Danlos syndromes)

Contacts and Locations

Study Contact

Sandra Mata-Diaz, MPH

CONTACT

2065988487

BTEVAR@uw.edu

Principal Investigator

Matthew P Sweet, MD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

University of Washington/Harborview Medical Center

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: University of Washington

Matthew P Sweet, MD, PRINCIPAL_INVESTIGATOR, University of Washington

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 Date2012-08

Study Completion Date2028-08

Study Record Updates

Study Start Date2012-08

Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

Thoracoabdominal Aortic Aneurysm
Branched vessels

Additional Relevant MeSH Terms

Thoracoabdominal Aortic Aneurysm, Without Rupture