Aortic Disorders
Conditions
Keywords
aortic disorders, endovascular grafts
Brief summary
The purpose of this study is to see if physician modified endovascular grafts (PMEG) can be used safely for the treatment of aortic disorders. The surgeon will modify a commercially available graft tailored to the participant's anatomy for surgery. The researchers will follow participants for 5 years, which will require regular visits to the clinic for follow-up imaging and follow-up blood tests.
Detailed description
The primary objective of the clinical investigation Duke CARES Trial is to assess the use of physician-modification of commercially available, off-the-shelf, endovascular stent-grafts to treat juxtarenal, pararenal and paravisceral complex abdominal aneurysms or thoracoabdominal aneurysms in high-risk for open surgery subjects having appropriate anatomy. The primary intent of the study is to assess safety and efficacy of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). Additionally, the study will assess domains for improvement of patient selection criteria, device design, operative techniques, and follow-up regimens to benefit patients undergoing complex endovascular aneurysm repair Main Study - Statistical Cohort Physician Modified Endovascular Grafts are indicated for endovascular repair of juxtarenal, pararenal, paravisceral and thoracoabdominal aneurysms, in high-risk for open surgery subjects having appropriate anatomy as defined in the eligibility section. Non-statistical cohort Patients with life-threatening aortic disease who have no acceptable surgical or endovascular alternatives will be allowed to receive treatment under this IDE. Enrollment of these patients under the IDE permits systematic data collection and FDA oversight, while their separation from the primary study cohort preserves the integrity of the safety and effectiveness analyses. This approach provides a treatment option for critically ill patients by offering access to a potential therapeutic option within a regulated and monitored environment without compromising the scientific validity of the trial. The patients in this cohort will follow standard of care, which includes follow-up at 1 month, 6 months and then annually. Data collection and presentation in this cohort will be consistent with the primary study cohort; however, data from this cohort will not be included in the statistical analysis.
Interventions
DEVICEPhysician Modified Endovascular Graft
The participant's surgeon will modify a commercially available graft tailored to their anatomy for their surgery. All components used to create the final device (PMEG), made specifically for each participant and tailored to their individual anatomy, are FDA-approved, although the final graft itself (the PMEG) is considered investigational.
Sponsors
Chandler Long, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
MAIN COHORT INCLUSION CRITERIA: * A participant may be entered into the study if the participant has at least one of the following: An aneurysm with a maximum diameter of \> 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements; Aneurysm with a history of growth \> 0.5 cm in 6 months; Saccular aneurysm deemed at significant risk for rupture; Symptomatic aneurysm; Ruptured aneurysm AND * Extent of aorta to be treated: juxtarenal, pararenal that include 1 or 2 renal and/or accessory renal arteries, paravisceral that includes celiac artery and/or superior mesenteric artery, and/or thoracoabdominal * High risk of morbidity and mortality with open surgical repair as defined by: a. Anatomic Criteria (Previous abdominal surgery; Previous thoracotomy; Previous aortic surgery) b. Physiologic Criteria (ASA Category III or higher; Age \>70 years; Previous myocardial infarction, coronary artery disease, or coronary artery stent; Coronary stress test with a reversible perfusion defect; Congestive heart failure (CHF); Chronic obstructive pulmonary disease (COPD)) * 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 25 mm (Diameter in the range of 18 mm - 42 mm; Angle less than 60o relative to the axis of the aneurysm; Angle less than 60o relative to the axis of the suprarenal aorta); * Minimum branch vessel diameter greater than 5 mm * Iliac artery distal fixation site greater than 20 mm in length and diameter in the range of 9 mm - 21 mm (for use of ZFEN) * Contralateral iliac artery distal fixation site greater than 20 mm in length and diameter in the range of 7.5 mm - 20 mm. * Age: ≥ 18 years old * Life expectancy: \> 2 years
Exclusion criteria
GENERAL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse events (MAE) | 30 days, or during hospitalization if this exceeds 30 days | The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. MAE include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and estimated procedural blood loss \> 1000 cc. |
| Proportion of study participants with treatment success | 1 year | Treatment success requires all the following criteria to be met: * Technical success * Absence of death from the initial procedure, secondary intervention, or aorta-related cause * Absence of persistent type I or type III endoleak * Absence of aneurysm sac expansion \>5 mm * Absence of device migration \>10 mm * Absence of failure due to device integrity issues * Absence of aneurysm rupture * Absence of conversion to open surgical repair * Device infection or thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Within 24 hours | Technical success - defined as the successful introduction, deployment and withdrawal of the device, in the absence of surgical conversion or mortality, absence of Type I and III endoleak, absence of branch occlusion ensuring unimpeded flow to the branch vessel(s) intended for preservation or absence of graft limb obstruction. |
| Incidence of death | 30 days | — |
| Incidence of bowel ischemia | 30 days | — |
| Incidence of myocardial infarction | 30 days | — |
| Incidence of paraplegia | 30 days | — |
| Incidence of renal failure | 30 days | — |
| Incidence of respiratory failure | 30 days | — |
| Incidence of stroke | 30 days | — |
| Estimated procedural blood loss > 1000 cc | During procedure | — |
| Incidence of paraparesis | 30 days | — |
| Proportion of study participants with treatment success | 30 days, 6 months, 2 years, 3 years, 4 years, and 5 years | Treatment success requires all the following criteria to be met: • Technical success • Absence of death from the initial procedure, secondary intervention, or aorta-related cause • Absence of persistent type I or type III endoleak • Absence of aneurysm sac expansion \>5 mm • Absence of device migration \>10 mm • Absence of failure due to device integrity issues • Absence of aneurysm rupture • Absence of conversion to open surgical repair • Device infection or thrombosis |
| Proportion of participants who experience any of the specified events | 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years | Events include: * Aneurysm enlargement * Aneurysm-related mortality * Aneurysm rupture * Conversion to open repair * Secondary intervention for: * Migration * Type I (a, b, c) endoleak (See definitions and Figure 1) * Type III (a, b, c) endoleak (See definitions and Figure 1) * Device integrity failure (e.g., fracture) * Patency-related events (i.e., device stenosis or occlusion and embolic events) * Renal failure * All-cause mortality * Endoleaks * Device integrity failure (e.g., fracture) * Patency -related events (i.e., endovascular graft or stent component stenosis or occlusion and embolic events) * Other device-related events |
Countries
United States
Contacts
CONTACTEllen R Burkett, MSHS
PRINCIPAL_INVESTIGATORChandler Long, MD
Duke University
Outcome results
None listed