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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Matthew P. Sweet, University of Washington
ClinicalTrials.gov Identifier:
NCT01874197
First received: June 6, 2013
Last updated: December 9, 2013
Last verified: December 2013

June 6, 2013
December 9, 2013
August 2012
August 2018   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01874197 on ClinicalTrials.gov Archive Site
Mortality rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Technical Success [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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.
Technical Success [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
 
Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic
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 physician modification of a currently FDA-approved off the shelf thoracic aortic stent graft (COOK Zenith® TX2®) to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms.

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.

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® or Endologix AFX™ devices 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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thoracoabdominal Aortic Aneurysm, Without Rupture
Device: B-TEVAR device
Creation and implantation of the Branched Thorcoabdominal aortic anerysm device
B -TEVAR
Implantation of the B-TEVAR device
Intervention: Device: B-TEVAR device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
August 2023
August 2018   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Ms Billi Tatum, RN,CCRC 206.744.3369 btatum@uw.edu
United States
 
NCT01874197
B120176
Yes
Matthew P. Sweet, University of Washington
University of Washington
Not Provided
Principal Investigator: Matthew P Sweet, MD University of Washington
University of Washington
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP