Prospective, Open-label, Multicenter, Non-randomized Clinical Study to Determine the Safety and Efficacy of SETA LATECBA Stent Graft for Endovascular Repair Therapy (EVAR) in Subjects With Abdominal Aortic Aneurysm (AAA).
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysm
- Sponsor
- Latecba S.A.
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan)
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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:
- •Diagnosis of an abdominal aortic aneurysm with a diameter ≥ 5.0 cm for males or ≥ 4.5 cm for females.
- •Aneurysm diameter with a growth rate ≥ 0.5 cm/ 6 months
- •The juxtarenal neck length between 1 mm and 10 mm
- •Neck diameter ≥16 to ≤ 26 mm
- •Suprarenal aorta diameter ≥ infrarenal aorta diameter
- •Proximal neck angulated ≤ 60 degrees relative to the long axis of the aneurysm
Exclusion Criteria
- •General Exclusion Criteria
- •Life expectancy less than 2 years
- •Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- •Included in another investigative drug or device study/studies or planning to do it within the following 24 months
- •Medical Exclusion Criteria
- •Previous treatment of AAA
- •Known allergy to polyester, stainless steel, nitinol and or gold, teflon, nylon,
- •Known anaphylactic reaction to contrast media.
- •Any type coagulopathy untreated.
- •Genetic connective tissue diseases, such as Marfan or Ehlers-Danlos syndromes
Outcomes
Primary Outcomes
EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan)
Time Frame: 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
Time Frame: 30-day
percentage of died subjects
Secondary Outcomes
- Incidence of post-operative complications(12 months)
- Clinical success(12 months)
- SAFETY: Major Adverse Events(30-day)
- Technical Success of stent-graft implantation and delivery system usage(12 months)