Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAA

Brief Title

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).

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.
    

Study Type

Interventional

Primary Outcome

EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan)

Secondary Outcome

 SAFETY: Major Adverse Events

Condition

Abdominal Aortic Aneurysm

Intervention

SETA LATECBA Stent Grafts

Study Arms / Comparison Groups

 treatment arm

Description:  SETA LATECBA Stent Grafts, are tube shaped implantable devices, delivered by balloon catheter system which are intended to the treatment of infrarenal AAA by sealing the affected areas, avoiding the bleeding or perfusion inside the aneurysm and restoring the normal hemodynamics in the affected vessels. The product family is composed by a set of endovascular stent grafts, that can be used alone or in combination, according to the treatment strategy, extension and complexity of the AAA. One aortic bifurcated stent graft, ABK SETA LATECBA model, is the aortic trunk and two straight iliac stent grafts, RIK SETA LATECBA model, are the connections to both iliac arteries.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

42

Start Date

December 11, 2019

Completion Date

March 31, 2022

Primary Completion Date

December 31, 2021

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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

The-Bao Bui, MD, 54 11 4952 1360, [email protected]

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT04220177

Organization ID

SETALATECBACAN002

Responsible Party

Sponsor

Study Sponsor

Latecba S.A.

Study Sponsor

The-Bao Bui, MD, Principal Investigator, Centre Hospitalier Universitaire Sherbrooke

Verification Date

January 2020