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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracoabdominal Aortic Aneurysm, Without Rupture
• Intervention / Treatment: Device: B-TEVAR device

Detailed Description

A branched thoracic endograft is a commercially manufactured endograft that has reinforced fenestrations or branches in the graft through which covered stent grafts can be deployed to preserve blood flow into visceral branch vessels.

The branched stent graft is deployed to reline the peri-visceral abdominal aorta. Proximal and distal fixation and seal can be achieved using the branched device, additional Cook Alpha Thoracic 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
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margo Godersky, MPH; Phone Number: 2065988487; Email: BTEVAR@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • University of Washington/Harborview Medical Center
      • Contact: Matthew Sweet, MD
      • Contact: Email: BTEVAR@uw.edu
      • Principal Investigator: Matthew P Sweet, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: B -TEVAR; Implantation of the B-TEVAR device	Device: B-TEVAR device; Creation and implantation of the Branched Thorcoabdominal aortic anerysm device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effectiveness of multi-branched endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success	12 months post-procedure.

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality rates	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	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.	12 months

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Matthew P Sweet, MD, University of Washington

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2028

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Thoracoabdominal Aortic Aneurysm; Branched vessels
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Aortic Diseases; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: STUDY00004379

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes