Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms

  • STATUS
    Recruiting
  • End date
    Sep 28, 2028
  • participants needed
    15
  • sponsor
    Medstar Health Research Institute
Updated on 28 October 2021

Summary

The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.

Description

This study is a prospective, single-center, non-randomized, single-arm study. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, computed tomography angiography (CTA) of chest, abdomen and pelvis, abdominal duplex ultrasound, creatinine measurement, quality of life questionnaire at specific, protocol-defined intervals for a period of five years following the physician-modified Cook Zenith Alpha Endovascular Graft implant.

Details
Condition Thoracic aortic aneurysm, Suprarenal Aortic Aneurysm, thoracoabdominal aortic aneurysm, Juxtarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysms
Treatment Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft
Clinical Study IdentifierNCT04526938
SponsorMedstar Health Research Institute
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years old
Life expectancy > 2 year(s)
Patient is considered to be at high risk of morbidity and mortality with open surgical repair
A patient may be entered into the study if the patient has at least one of the
following
Juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm with a diameter 5.5 cm or 2 times the normal aortic diameter
Aneurysm with a history of growth 0.5 cm per year
Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation
Symptomatic juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm
Thoracoabdominal aortic aneurysms secondary to aortic dissection meeting above criteria
Patient is considered to be at high risk of morbidity and mortality with open surgical repair
Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
Nonaneurysmal aortic segment proximal to the aneurysm (neck) with a
Minimum neck length of 20mm
Diameter in the range of 21-38mm
Angle less than 60 relative to the axis of the aneurysm
Angle less than 60 relative to the axis of the suprarenal aorta
Minimum branch vessel diameter greater than 5 mm
Iliac artery distal fixation site greater than 10mm in length and diameter in the range of 8-21mm

Exclusion Criteria

Under the age of 18 years
Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
Unwilling to participate in a sponsor-investigator IDE with access to a non-physician modified endovascular prostheses at the investigational site
Unwilling to travel to an investigational site with access to a non-physician modified endovascular prosthesis
Unwilling or unable to comply with the follow-up schedule
Inability or refusal to give informed consent by patient or legal representative
Patient is pregnant or breastfeeding
Life expectancy < 2-years despite successful aneurysm exclusion
Free rupture with hemodynamic instability
Ongoing infection
Diagnosis of, or suspected connective tissue disease
Prior open or endovascular repair of the infrarenal aorta with a non-Cook device
Known sensitivities or allergies to the materials of construction of the devices
Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
Uncorrectable coagulopathy
Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned 30 days of the endovascular repair
Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
Systemic or local infection that may increase the risk of endovascular graft infection
Leaking or free rupture of aneurysm associated with hemodynamic instability
Baseline creatinine greater than 3.0 mg/dL
Known history of, or suspected connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
Anatomical exclusion criteria
Inadequate femoral or iliac access compatible with the required delivery systems, not amenable to open surgical or endovascular conduit placement
Absence of a non-aneurysmal aortic segment for proximal seal zone with
A diameter measured outer wall to outer wall of no greater than 38mm and no less than 21 mm
Parallel aortic wall with <20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone
Visceral vessel anatomy not compatible with physician-modified Zenith Alpha Endovascular Graft due to excessive occlusive disease or small size not amenable to stent graft placement
Unsuitable distal iliac artery fixation site and anatomy
Common iliac artery fixation site diameter measured outer wall to outer wall on a sectional image (CT) <8.0 mm with inability to perform open surgical conduit
Iliac artery diameter measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft
Iliac artery distal fixation site <10 mm in length
Inability to preserve at least one hypogastric artery
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