Clinical trial NCT04220177: Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAA
Official title: 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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Latecba S.A.
Sponsor class: INDUSTRY
First posted: 2020-01-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Open-label, Multicenter, Non-randomized
Primary purpose: TREATMENT

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.

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:

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 Exclusion Criteria

  1. Life expectancy less than 2 years
  2. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  3. Included in another investigative drug or device study/studies or planning to do it within the following 24 months

Medical Exclusion Criteria

1. Previous treatment of AAA
2. Known allergy to polyester, stainless steel, nitinol and or gold, teflon, nylon,
3. Known anaphylactic reaction to contrast media.
4. Any type coagulopathy untreated.
5. Genetic connective tissue diseases, such as Marfan or Ehlers-Danlos syndromes
6. Planned interventional or surgical procedure within 30 days before or after AAA repair.
7. Renal dysfunction: creatinine level over 1.7 mg/dl
8. Systemic infection or fever over 38°C

   AAA Anatomy Exclusion Criteria
9. Significant occlusive disease, tortuosity, or calcification.

i) Significant thrombus in the fixation sites. j) Fungal aneurysm k) Leaking/ruptured or symptomatic aneurysm. l) Traumatic aneurysm. m) Concurrent aneurysm of the thoracic aorta. n) One or both renal arteries coming from the aneurysmal sac. o) Proximal neck diameter, measured outer wall to outer wall on a sectional image (CTA) \> 26 mm in diameter or \< 16 mm in diameter p) Proximal neck angle \> 60 degrees relative to the long axis of the aneurysm q) Immediate suprarenal aorta angle \> 60 degrees relative to the immediate infrarenal neck.

r) Immediate suprarenal aorta angle \> 60 degrees relative to the immediate infrarenal neck s) Aortic diameter, measured inner wall to inner wall on a sectional image (CTA) \< 15 mm at the bifurcation t) Iliac/femoral anatomy that is unsuitable for access. u) Iliac artery diameter, measured outer wall to outer Wall on a sectional image (CTA) \> 20 mm or \< 8 mm at distal fixation site.

v) Iliac artery distal fixation site \< 10 mm in length. w) Indispensable inferior mesenteric artery (IMA)

Primary outcomes:
measure: EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan)
timeFrame: 30 days
measure: SAFETY: mortality
timeFrame: 30-day
Secondary outcomes:
measure: SAFETY: Major Adverse Events
timeFrame: 30-day
measure: Incidence of post-operative complications
timeFrame: 12 months
measure: Clinical success
timeFrame: 30-day
measure: Clinical success
timeFrame: 6 months
measure: Clinical success
timeFrame: 12 months
measure: Technical Success of stent-graft implantation and delivery system usage
timeFrame: 12 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire Sherbrooke
state: Montreal
Study officials:
affiliation: Centre Hospitalier Universitaire Sherbrooke
name: The-Bao Bui, MD
role: PRINCIPAL_INVESTIGATOR
References: