Bulge or swelling due to weaking of the walls of the aorta Bulge or swelling due to weaking of the walls of the aorta
Conditions
Interventions
The procedure at which the Aortic Stent Graft (for the Control arm) and the
IMPEDE-FX RapidFill System (for the Treatment arm) is considered the index
procedure/treatment for this clinical trial. Th
refer to the
corresponding device IFU regarding the specific steps for device access,
deployment, and withdrawal.
Sponsors
Shape Memory Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. >=18 years of age 2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm >=5.5 cm in diameter in men and >= 5.0 cm in women 3. Thrombus burden (percentage of the AAA sac occupied by thrombus) =40mm 5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is
Exclusion criteria
Exclusion criteria: General 1. An inability to provide informed consent 2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial 3. Unable or unwilling to comply with study follow-up requirements 4. Prisoner or member of other vulnerable population Anatomical 1. Concomitant iliac artery ectasia or aneurysm 2. Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac 3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm 4. Connective tissue disorder (e.g., Marfan*s syndrome) 5. Aneurysmal disease of the descending thoracic aorta 6. Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties EVAR/Procedural 1. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA 2. Use of an aortic stent graft other than those specified2 for a particular site 3. Planned use of the chosen stent graft outside its IFU 4. Use of fenestrated stent grafts or chimney techniques 5. Use of the Heli-FX EndoAnchor system 6. Use of embolic devices other than the investigational product to embolize the AAA sac 7. Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries 8. Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries Medical History/Conditions 1. Coagulopathy or uncontrolled bleeding disorder 2. Serum creatinine level >2.5 mg/dL 3. Cerebrovascular accident within 3 months prior to the procedure 4. Myocardial infarction and/or major heart surgery within 3 months prior to the procedure 5. Atrial fibrillation that is not well rate controlled 6. Life expectancy of 11,000/mm3) 9. A condition that inhibits radiographic visualization during the implantation procedure 10. History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason 11. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial 12. Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Effectiveness Endpoint: The percentage of subjects showing regression, defined as sac volume reduction of >=10% at 1 year, and no AAA-related intervention through 1 year. Sac volume reduction is defined as the AAA volume (minus the stent graft volume) at the 1-year visit minus the same measurement at the 30-day visit. Dividing this difference by the volume measurement at the 30-day visit yields a percentage reduction (volume shrinkage will be a negative number). Primary Safety Endpoint: Freedom from the following through 30 days post-index procedure: • Major adverse events (MAEs) o MAEs (CEC adjudicated) include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1000 mL. MAEs are further defined below. • AAA-rupture or AAA-perforation • Conversion to Open Repair | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Effectiveness Endpoints: • The percentage of subjects showing regression, defined as sac diameter reduction of >=5mm at 1 year, and no AAA-related intervention through 1 year. • Incidence of large endoleaks (>2.4) through 1 year • Incidence of sac diameter enlargement through 1 year • Incidence of Type II endoleak and sac diameter enlargement through 1 year Secondary Effectiveness Metrics: The following metrics are determined at the time of investigational device implant: • Technical failure (defined as failure to implant at least 100% of the calculated minimum number of IMPEDE-FX RapidFill Implants into the AAA sac, or exceeding the maximum number of implants) • An indication of the amount of sac filling: the number of IMPEDE-FX RapidFill Implants inserted. The following metrics are determined at each follow-up visit: • Change in both AAA sac diameter and volume at 6 months, 1 year, and annually, based on the diameter/volume determined from the 30-day CTA. • Rate of endoleaks, overall and stratified by type • Other EVAR measures of success/failure (impact of IMPEDE-FX RapidFill to be discussed) o EVAR graft migration, patency, stenosis, kinking The following metric is Adverse Event (AE) based and is recorded as AEs are observed by the site: • Rate of secondary AAA-related interventions, as adjudicated by the CEC Secondary Safety Metrics: The following metrics are AE based and are recorded as they are observed by the site: • All MAEs from the day of procedure through all time points. Relatedness to the investigational product/procedure to be adjudicated by the CEC. • All serious adverse events (SAEs) through all time points. Relatedness to the investigational product/procedure to be adjudicated by the CEC. • Rate of conversion to open AAA repair • Rate of AAA-rupture or AAA-perforation • Rate of access site complications • Clinically significant misplacement or migration of the IMPEDE-FX RapidFill Implants or EVAR imp | — |
Countries
Italy, Netherlands, New Zealand, United Kingdom, United States
Contacts
Public ContactP. Miller
Shape Memory Medical
Outcome results
None listed