Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms
Primary Purpose
Juxtarenal Aortic Aneurysm, Suprarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft
Sponsored by
About this trial
This is an interventional treatment trial for Juxtarenal Aortic Aneurysm focused on measuring Complex Aortic Aneurysm, Complex Abdominal Aortic Aneurysm, Aneurysm
Eligibility Criteria
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
- Willing to participate in a sponsor-investigator IDE with access to a non-physician modified endovascular prostheses at the investigational site
- Willing 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
- 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
Sites / Locations
- MedStar Washington Hospital CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endovascular repair
Arm Description
Endovascular repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms including those secondary to aortic dissection using a physician-modified endovascular graft.
Outcomes
Primary Outcome Measures
Freedom from Major Adverse Events (MAE) at 30 days
Major Adverse Events include: Death, Bowel Ischemia, myocardial infarction, paraplegia/paraparesis, renal failure, respiratory failure, and stroke
Proportion of study subjects with treatment success at 1 year
Treatment success is defined as a composite of technical success and freedom from the following:
Aneurysm enlargement [i.e., >5mm) as compared to a preoperative CT measure using orthogonal (i.e, perpendicular to the centerline) measurements]
Aneurysm rupture
Aneurysm-related mortality
Conversion to open repair
Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)
Technical success
Technical success is defined as:
Successful delivery (i.e., ability to deliver the implant to the intended implantation site, without the need for unanticipated corrective intervention related to delivery) and deployment of the device at the intended location,
Patency of all endovascular graft and branch stent components
Absence of device deformations requiring unplanned placement of an additional device
Absence of inadvertent covering of aortic branch vessels
Successful withdrawal (i.e., successful withdrawal of the delivery system, without need for unanticipated corrective intervention related to withdrawal)
Secondary Outcome Measures
Quality of Life measures
Questionnaire using SF - 36™ Health Survey
Full Information
NCT ID
NCT04526938
First Posted
August 21, 2020
Last Updated
May 22, 2023
Sponsor
Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04526938
Brief Title
Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms
Official Title
Clinical Outcomes, Radiation Dosage, and Quality of Life in Patients Treated With Fenestrated Stent Grafts for Complex Thoracoabdominal and Abdominal Aortic Aneurysms, Thoracoabdominal Aortic Aneurysms Secondary to Aortic Dissections
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
September 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juxtarenal Aortic Aneurysm, Suprarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Keywords
Complex Aortic Aneurysm, Complex Abdominal Aortic Aneurysm, Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endovascular repair
Arm Type
Experimental
Arm Description
Endovascular repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms including those secondary to aortic dissection using a physician-modified endovascular graft.
Intervention Type
Device
Intervention Name(s)
Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft
Intervention Description
Cook Zenith® Alpha Thoracic Endovascular Graft will be modified to allow for the maintenance of blood flow into the visceral and renal branch vessels.
Primary Outcome Measure Information:
Title
Freedom from Major Adverse Events (MAE) at 30 days
Description
Major Adverse Events include: Death, Bowel Ischemia, myocardial infarction, paraplegia/paraparesis, renal failure, respiratory failure, and stroke
Time Frame
30 days
Title
Proportion of study subjects with treatment success at 1 year
Description
Treatment success is defined as a composite of technical success and freedom from the following:
Aneurysm enlargement [i.e., >5mm) as compared to a preoperative CT measure using orthogonal (i.e, perpendicular to the centerline) measurements]
Aneurysm rupture
Aneurysm-related mortality
Conversion to open repair
Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)
Time Frame
1 year
Title
Technical success
Description
Technical success is defined as:
Successful delivery (i.e., ability to deliver the implant to the intended implantation site, without the need for unanticipated corrective intervention related to delivery) and deployment of the device at the intended location,
Patency of all endovascular graft and branch stent components
Absence of device deformations requiring unplanned placement of an additional device
Absence of inadvertent covering of aortic branch vessels
Successful withdrawal (i.e., successful withdrawal of the delivery system, without need for unanticipated corrective intervention related to withdrawal)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of Life measures
Description
Questionnaire using SF - 36™ Health Survey
Time Frame
30 days, 6 months; 1, 2, 3, 4 and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Willing to participate in a sponsor-investigator IDE with access to a non-physician modified endovascular prostheses at the investigational site
Willing 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jake Sutton
Phone
202-877-6624
Email
joseph.a.sutton@medstar.net
First Name & Middle Initial & Last Name or Official Title & Degree
Suman Singh, MPH
Phone
202-877-8475
Email
suman.singh@medstar.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javairiah Fatima, MD
Organizational Affiliation
Medstar Washington Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jake Sutton
Phone
202-877-6624
Email
joseph.a.sutton@medstar.net
First Name & Middle Initial & Last Name & Degree
Suman Singh, MPH
Phone
202-877-8475
Email
suman.singh@medstar.net
First Name & Middle Initial & Last Name & Degree
Javairiah Fatima, MD
12. IPD Sharing Statement
Learn more about this trial
Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms
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