Abdominal Aortic Aneurysm
Conditions
Brief summary
This is a Prospective, Open-label, Multicenter, and Non-randomized Clinical Study. The main purpose of this study is to establish the efficacy and safety of a medical device system, SETA LATECBA Stent Graft, intended for the treatment of EVAR of pararenal AAA (patients with complex anatomy, not eligible for other surgical procedure).Other objective is to evaluate the technical performance of the device SETA LATECBA Stent Graft.
Detailed description
This is a Prospective, Open-label, Multicenter, and Non-randomized Clinical Study to determine the Safety and Efficacy of the SETA LATECBA Stent Graft for endovascular repair therapy (EVAR) in Subjects with Abdominal Aortic Aneurysm (AAA)..The main purpose of this study is to establish the efficacy and safety of a medical device system, SETA LATECBA Stent Graft, intended for the treatment of Endovascular Aneurysm Repair (EVAR) of pararenal AAA (patients with complex anatomy, not eligible for other surgical procedure). Secondary objective(s): The secondary objective is to evaluate the technical performance of the device SETA. LATECBA Stent Graft which includes: access to the implantation site, visualization, deployment of the stent- graft, sizing compatibility, withdrawal of the delivery system, and compatibility with ancillary equipment.
Interventions
DEVICESETA LATECBA Stent Grafts
ABK model is a bifurcated polyester graft partially corrugated which is sutured at the proximal end (renal) to a balloon expandable 316 L stainless steel stent. The proximal half part of the stent is uncovered by polyester graft providing the anchoring to the healthy aorta wall when the device is implanted, as well as the perfusion of the renal arteries. The remaining half part is covered by polyester graft providing sealing of the aneurysm when it is expanded upon on the graft fabric and aneurysm neck. The distal end of each branch has the anchorage site for sealing after the connection with the iliac extensions RIK. The diameter of the anchorage site varies with the different ABK codes. The end of one branch is cone-shaped after the anchoring diameter with the purpose of promoting insertion of iliac extension RIK. The connection to iliac arteries is achieved by completing the aortic trunk ABK with 2 iliac extensions RIK.
Sponsors
Latecba S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, Open-label, Multicenter, Non-randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female adults older than 18 years old, willing to cooperate with the study. No other demographic restriction. * Initial diagnosis of AAA according to the standard of care criteria following the guidance Clinical Practice Guidelines for Endovascular Abdominal Aortic Aneurysm Repair * Medical history: Complete history of previous, present and concomitant conditions, and current treatments for other conditions Signed informed consent. If the patient cannot consent, the subject's legally acceptable representative should consent Diagnosis of Abdominal Aortic Aneurysm (AAA) according to the following criteria: 1. Diagnosis of an abdominal aortic aneurysm with a diameter ≥ 5.0 cm for males or ≥ 4.5 cm for females. 2. Aneurysm diameter with a growth rate ≥ 0.5 cm/ 6 months 3. The juxtarenal neck length between 1 mm and 10 mm 4. Neck diameter ≥16 to ≤ 26 mm 5. Suprarenal aorta diameter ≥ infrarenal aorta diameter 6. Proximal neck angulated ≤ 60 degrees relative to the long axis of the aneurysm 7. Immediate suprarenal aorta angulated ≤ 60 degrees relative to the immediate infrarenal neck. 8. Common iliac diameter 8 to 20 mm. 9. Common iliac length 25 mm 10. Common iliac angle 60 degrees 11. Not eligible for other standard EVAR surgical procedure
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan) | 30 days | Type I endoleaks is diagnosed when there is a gap between the stent graft and the vessel wall. Usually is a result of the failure of the stent graft to achieve a circumferential seal of the aneurism. It produces systemic pressurization of the aneurysm sac and increases the risk of sac rupture. |
| SAFETY: mortality | 30-day | percentage of died subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SAFETY: Major Adverse Events | 30-day | Composite endpoint including Q-wave myocardial infarction, Congestive heart failure, Cardiac ischemia requiring intervention Renal failure requiring dialysis, Bowel obstruction, ischemia or fistula, Stroke, Paralysis, Aneurysm leak and Device related death |
| Incidence of post-operative complications | 12 months | Complications of aneurysm repair followed by secondary interventions |
| Clinical success | 30-day | Composite endpoint including Successful deployment at intended site, No migration, Aneurysm exclusion, no type III and/or IV endoleak, No graft infection, No graft thrombosis, No aneurysm rupture, No conversion to open repair, |
| Technical Success of stent-graft implantation and delivery system usage | 12 months | Composite endpoint including Assessment of system performance (Procedural times, Total blood loss, Deployment and device patency Ease of insertion, Visualization, Delivery system retrieval, Device integrity, Kinks, No type IV endoleak) Ancillary equipment needed, Adjunctive maneuvers (Balloon dilatation of aortic neck Balloon dilatation of iliac arteries, Additional stent or surgical procedure required, Eventual use of proximal cuff, Contrast media volume) |
Countries
Canada
Contacts
Primary ContactEzequiel Klimovsky, MD
Backup ContactFrancisco Barone, Eng
Outcome results
None listed