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

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).

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: SETA LATECBA Stent Grafts

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
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ezequiel Klimovsky, MD; Phone Number: 54 11 4952 1360; Email: eklimovsky@quid-consulting.com
• Study Contact Backup: Name: Francisco Barone, Eng; Phone Number: 54 11 49120064; Email: fbarone@latecba.com

Study Locations

• Canada
  • Montreal
    • Sherbrooke, Montreal, Canada
      • Recruiting
      • Centre Hospitalier Universitaire Sherbrooke
      • Contact: Guylaine Provencher, MD; Phone Number: 819 8206480

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: treatment arm; 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.

Device: SETA 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.; Other Names: ABK SETA LATECBA; RIK SETA LATECBA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan)	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.	30 days
SAFETY: mortality	percentage of died subjects	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAFETY: Major Adverse Events	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	30-day
Incidence of post-operative complications	Complications of aneurysm repair followed by secondary interventions	12 months
Clinical success	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,	30-day
Clinical success	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	6 months
Clinical success	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	12 months
Technical Success of stent-graft implantation and delivery system usage	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)	12 months

Collaborators and Investigators

• Sponsor: Latecba S.A.
• Investigators: Principal Investigator: The-Bao Bui, MD, Centre Hospitalier Universitaire Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 5, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: SETALATECBACAN002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No