Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 770
- Locations
- 2
- Primary Endpoint
- Change from baseline in renal function over time (up to two years) after endovascular aortic aneurysm repair various custom stent grafts
Study Overview
Brief Summary
The purpose of this study is to evaluate visceral function, after endovascular repair of thoracoabdominal aneurysms or ascending/aortic arch aneurysms.
Detailed Description
This study will evaluate the effect of endovascular repair of thoracoabdominal aortic aneurysms (Types I-IV) on visceral function or aortic arch aneurysms using custom manufactured and off the shelf stent grafts. Specifically, the device orientation and configuration will be evaluated with respect to renal function. Since detailed CT scan imaging will be performed prior to and after endovascular repair, critical data concerning each branched vessel length, tangential orientation from the aorta, angle of incidence, and diameter can be determined. This information can then be coupled with hemodynamic data obtained from duplex ultrasonography as well as changes in renal volume, estimated glomerular filtration rate (eGFR), and flow characteristics over time. By analyzing the data in this fashion, it may be possible to determine changes in hemodynamics and/or physiologic conditions with respect to branched stent-graft design characteristics. These data may be utilized to enhance current device design and improve patient outcomes. The FDA has approved the use of commercially available devices to be used in conjunction with the investigational device if the Investigator deems this necessary.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cohort 1 (TAAA) Inclusion Criteria:
- •Patients may be included in the study if the patient has at least one of the following and has aortic anatomy appropriate for treatment with the Zenith® p-Branch™, Zenith® t-Branch, or Physician Specified TAAA Endovascular Graft (Custom Manufactured Devices).
- •Aortic Aneurysm Diameter
- •a. TAAA (Type I - IV) (including pararenal subtypes) with orthogonal aortic diameter greater than or equal to 5 cm or b. greater than two times the normal aortic diameter
- •Rapid aortic enlargement (> than or equal to 5mm in 1 year)
- •Presence of a saccular aneurysm at risk for rupture based on investigators evaluation
- •Iliac artery aneurysm ˃2.2 cm may be treated with the Zenith® Branch Endovascular Graft-Iliac Bifurcation when the iliac artery aneurysm is associated with the qualifying thoracoabdominal aneurysm treated in this study
Exclusion Criteria
- •General Exclusion Criteria
- •Patients must be excluded from the study if any of the following conditions are true:
- •Less than 18 years of age
- •Unwilling to comply with the follow-up schedule
- •Inability or refusal to give informed consent
- •Medical Exclusion Criteria
- •Patients must be excluded from the study if any of the following conditions are true:
- •1) Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold 2) History of anaphylactic reaction to contrast material that cannot be adequately premedicated 3) Leaking, ruptured aneurysm associated with hypotension 4) Uncorrectable coagulopathy
- •Anatomical Exclusion Criteria
- •Patients must be excluded from the study if any of the following conditions are true:
- •Inadequate femoral/iliac access compatible with the required delivery systems;
- •Does not have a non-aneurysmal aortic segment proximal to the aneurysm with:
- •a. A length of at least 4 mm, i.e. at least 4 mm circumferential wall contact around the limits of scallop b. A diameter measured outer wall to outer wall of no greater than 31mm and no less than 21 mm; c. An angle less than 60 degrees relative to the centerline of the aneurysm; d. An angle less than 45 degrees relative to the supraceliac aorta.
- •Does not have visceral vessel anatomy compatible with Zenith® p-Branch™, specifically:
- •a. Renal vessel origins as measured relative to the superior mesenteric artery (SMA) compatible with the renal fenestration, i.e. Both renal vessel origins within 7.5mm of the corresponding renal fenestrations; b. Celiac vessel origin as measured relative to the superior mesenteric artery (SMA) compatible with the celiac scallop.
- •A proximal seal site with unsuitable thrombus/atheroma
- •Does not have iliac artery fixation sites and anatomy consistent with:
- •Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) <8.0 mm (prior to deployment)
- •Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site
- •Iliac artery distal fixation site <10 mm in length
- •Inability to preserve at least one hypogastric artery
- •Cohort 2 (ascending/aortic arch) Inclusion Criteria:
- •General Inclusion Criteria:
- •Treatment not possible with a currently available non-modified approved device
- •Patient accepts to and is able to comply with lifetime follow-up
- •Patient accepts to and is able to provide informed consent prior to enrollment
- •No stroke with significant residual deficit or myocardial infarction within the last 12 months
- •No significant carotid bifurcation disease (> 70% stenosis by NASCET criteria)
- •Absence of systemic or local infection that may increase the risk of endovascular graft infection
- •Patient determined to be a high-risk profile for open surgical repair considering any of the following items:
- •Anatomy: previous sternotomy or left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta), previous aortic surgery, large aneurysm abutting the sternum with risk of disruption during sternotomy, prior cervical or chest irradiation.
- •Physiology: ASA Category ≥ III, age >70 years, previous myocardial infarction, coronary artery disease, or coronary artery stent, coronary stress test with a reversible perfusion defect, COPD, congestive heart failure
- •Vascular Inclusion Criteria:
- •Aortic Aneurysm Diameter: Ascending and/or Arch aneurysm with or without aortic or aortoiliac aneurysm with orthogonal aortic diameter greater than two times the normal aortic diameter
- •Rapid aortic enlargement (≥ 5 mm in 1 year)
- •Presence of a saccular aneurysm at risk for rupture based on the investigators evaluation
- •Clinical indication for aneurysm repair based on symptoms
- •Concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.
- •Anatomic Inclusion Criteria:
- •1) There is enough space for the device to be deployed distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion 2) Ascending aortic length >50 mm (greater curve distance from sinotubular junction to proximal aspect of the innominate artery) 3) Sealing zone in the ascending aorta >40 mm in length and <38 mm in diameter for native aorta (<42 mm if surgical graft replacement in place) 4) Sealing zone in the great vessels of >20 mm in length
- •Diameter of innominate artery used for sealing < 20 mm
- •Diameter of CCA or subclavian artery used for sealing < 16mm
- •Distal aortic fixation zone: Native aorta or surgical graft (endovascular device or Dacron graft) , diameter: 20-42mm, distal neck length ≥20mm 6) Access for device delivery to accommodate 22F or 24F sheath depending on device design.
- •7) Sealing zone in the great vessels of ≥ 20 mm in length
- •Diameter of innominate artery used for sealing between 8 and 20 mm
- •Diameter of CCA or subclavian artery used for sealing between 6 and 16 mm.
- •Extra inclusion criteria - special situations:
- •Aortic dissection:
- •A true lumen size large enough for device deployment and to gain access into the target branches
- •A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, so that the graft would seal off the dissection lumen
- +25 more not shown
Arms & Interventions
Endovascular TAAA Repair
Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using Branched stent grafts
Intervention: Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using branched stent graft (Device)
Endovascular Ascending/Aortic Arch Branch Repair
Endovascular repair of aortic ascending/arch aneurysm using branched stent grafts
Intervention: Endovascular repair of ascending/arch aortic aneurysm using branched stent graft (Device)
Outcomes
Primary Outcomes
Change from baseline in renal function over time (up to two years) after endovascular aortic aneurysm repair various custom stent grafts
Time Frame: Pre-procedure and 1, 6, 12, 18, and 24 months post procedure
Visceral function after endovascular repair of pararenal aneurysms using various custom stent grafts. Specifically, the device orientation and configuration will be evaluated with respect to renal function over time. Critical data concerning each branched vessel from radiological studies coupled with hemodynamic data obtained from renal artery duplex, changes in renal volume, eGFR, and flow characteristics at 1, 6, 12, 18 and 24 months post procedure may make it possible to determine changes in renal function.
Secondary Outcomes
- Time to morbidity(30 days and 1 & 2 years post procedure)
- Time to mortality(30 days and 1 & 2 years post procedure)
- Time to migration(30 days and 1 & 2 years post procedure)
- Branch vessel Events(30 days and 1 & 2 years post procedure)
- Time to loss of stent graft integrity(30 days and 1 & 2 years post procedure)
- Endoleak(30 days and 1 & 2 years post procedure)