- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01654133
Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Heart and Vascular
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
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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 5. 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
- A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection or surgically created
- Access into the true lumen from the groin and to at least one supra-aortic trunk vessel
If more distal disease is observed in the aorta
- The repair might be coupled with a thoracoabdominal branched device
- Iliac anatomy large enough to allow the delivery of the arch branch device which is loaded within a 20F-24F sheath. Iliac conduits may be set in place if necessary.
Exclusion Criteria:
General exclusion criteria:
- Life expectancy less than 2 years
- Less than 18 years of age
- Women must not be pregnant or breastfeeding
- Active malignancy with life expectancy less than 2 years
- Presence of mycotic aneurysm, systemic or local infection in access sites that may increase the risk of endovascular graft infection
- Untreatable coagulopathy
- Coronaropathy / Unstable angina
- Anaphylactic reaction to contrast that cannot be adequately pre-medicated
- Cultural objection to receipt of blood or blood products
- Allergy or sensitivity to the endografts material (stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol)
- Leaking or ruptured aneurysm associated with hypotension
- Participation in another investigational clinical or device trial, except for participation in another investigational endovascular stent-graft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair
- Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned procedures to provide access for repair (e.g. staged iliac conduit, cervical debranching) or to facilitate the procedure.
Anatomic Exclusion Criteria for the Cook Ascending/Arch graft
- Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access.
- Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) <7.0 mm at any point along access length (prior to deployment). Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access.
- Proximal seal length < 40 mm
Proximal seal site with a circumferential thrombus/atheroma/calcium
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endovascular TAAA Repair
Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using Branched stent grafts
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Repair of thoracoabdominal aortic aneurysms
Other Names:
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Experimental: Endovascular Ascending/Aortic Arch Branch Repair
Endovascular repair of aortic ascending/arch aneurysm using branched stent grafts
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Repair of ascending/arch aortic aneurysms
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Pre-procedure and 1, 6, 12, 18, and 24 months post procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to morbidity
Time Frame: 30 days and 1 & 2 years post procedure
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Morbidity at 30 days, 1 & 2 years post procedure
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30 days and 1 & 2 years post procedure
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Time to mortality
Time Frame: 30 days and 1 & 2 years post procedure
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Mortality at 30 days, 1 & 2 years post procedure.
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30 days and 1 & 2 years post procedure
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Time to loss of stent graft integrity
Time Frame: 30 days and 1 & 2 years post procedure
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Evidence on contrast CT angiography of loss of stent graft integrity at 30 days, and one and two years post procedure.
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30 days and 1 & 2 years post procedure
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Time to migration
Time Frame: 30 days and 1 & 2 years post procedure
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Evidence of stent graft migration on abdominal x-rays at 30 days and 1 & 2 years.
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30 days and 1 & 2 years post procedure
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Endoleak
Time Frame: 30 days and 1 & 2 years post procedure
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Evidence of Endoleak on contrast CT angiography of abdomen 30 days and 1 & 2 years post procedure.
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30 days and 1 & 2 years post procedure
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Branch vessel Events
Time Frame: 30 days and 1 & 2 years post procedure
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Evidence of branch vessel events on contrast CT angiography and renal duplex 30 days, and 1 & 2 years post procedure.
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30 days and 1 & 2 years post procedure
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Collaborators and Investigators
Investigators
- Principal Investigator: Mark A Farber, MD, University of North Carolina, Chapel Hill, NC 27599
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-0644
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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