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

Not Applicable

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: SETA LATECBA Stent Grafts

• Registration Number: NCT04220177
• Lead Sponsor: Latecba S.A.

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 Timeline

• Study Start: 2019-12-11
• Status Verified: 2020-01
• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-05
• Last Update Submitted: 2020-01-06
• Study First Posted: 2020-01-07
• Last Update Posted: 2020-01-09
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	SETA LATECBA Stent Grafts	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of post-operative complications	12 months	Complications of aneurysm repair followed by secondary interventions
Clinical success	12 months	Composite endpoint including No migration, Aneurysm exclusion, no type I, III and/or IV endoleak, No graft thrombosis, No aneurysm rupture. No aneurysm diameter expansion \>5 mm, No conversion to open repair
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
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)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Sherbrooke; 🇨🇦 Sherbrooke, Montreal, Canada