Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic (B-TEVAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01874197
Recruitment Status : Recruiting
First Posted : June 10, 2013
Last Update Posted : September 10, 2018
Information provided by (Responsible Party):
Matthew P. Sweet, University of Washington

Brief Summary:

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 both physician modification of a currently FDA-approved off the shelf thoracic aortic stent graft (COOK Zenith® TX2®) as well as 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 physician modified branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.

Condition or disease Intervention/treatment Phase
Thoracoabdominal Aortic Aneurysm, Without Rupture Device: B-TEVAR device Not Applicable

Detailed Description:

A physician modified branched thoracic endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating reinforced fenestrations in the graft through which covered stent grafts can be deployed to preserve blood flow into visceral branch vessels. The graft is deployed on a sterile working table in the operating room. The locations of the fenestrations are marked on the graft according to the pre-procedure measurements. The graft fabric is cut and simultaneously heat sealed using thermal Cautery. These fenestrations/cuffs are marked with medical grade metal markers to facilitate fluoroscopic visualization during the procedure. Furthermore, the fenestrations are reinforced with a short ring of PTFE. This added material is essential as it strengthens the fenestration and creates a ring within which the branch grafts can seal. After the fenestrations have been created, marked, and reinforced, additional metal radio-opaque markers are sewn to the graft to assist in device orientation under fluoroscopy. Additional sutures may be used at that time to constrain the endograft, either in a temporary or permanent fashion to facilitate subsequent deployment. The device is the re-constrained and re-sheathed within the original Zenith® TX2® delivery sheath.

The modified stent graft is then deployed to reline the peri-visceral abdominal aorta. Proximal and distal fixation and seal can be achieved using the modified TX2® device, additional unmodified TX2® devices and/or the Cook Zenith® Flex® device depending on the aortic anatomy.

Once the aortic stent grafts are deployed, the branches are then created. Wires and catheters are used to cross through the reinforced fenestrations into the target visceral arteries. Covered stents are then deployed to extend from the modified aortic graft to the target vessel. The branch stents must create a hemostatic seal with the main endograft as these branches will be constructed within the aneurysm sac. Single or multiple stents may be required for any given branch.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms: An Investigator-Initiated Study
Study Start Date : August 2012
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2028

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Implantation of the B-TEVAR device
Device: B-TEVAR device
Creation and implantation of the Branched Thorcoabdominal aortic anerysm device

Primary Outcome Measures :
  1. The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success [ Time Frame: 12 months post-procedure. ]

Secondary Outcome Measures :
  1. Mortality rates [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Technical Success [ Time Frame: 12 months ]
    Technical Success is defined as successful delivery and deployment of the physician modified graft with preservation of unimpeded flow to those branch vessels intended to be preserved.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:

  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:

A. Non-aneurysmal proximal aortic seal zone:

  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

    B. Non-aneurysmal distal aortic or iliac landing zone:

  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.

Exclusion Criteria:

Patients that meet ANY of the following are not eligible for enrollment into the study:

  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01874197

Contact: Jennifer Cox, MASc

United States, Washington
University of Washington/Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Matthew Sweet, MD    206-598-1154      
Contact: Jennifer Cox, MASc   
Principal Investigator: Matthew P Sweet, MD         
Sponsors and Collaborators
University of Washington
Principal Investigator: Matthew P Sweet, MD University of Washington

Responsible Party: Matthew P. Sweet, Associate Professor, Surgery, University of Washington Identifier: NCT01874197     History of Changes
Other Study ID Numbers: STUDY00004379
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Matthew P. Sweet, University of Washington:
Thoracoabdominal Aortic Aneurysm
Branched vessels

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries