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

NCT04220177 | Unknown

• 1 other identifier: SETALATECBACAN002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• SAFETY: Major Adverse Events

  30-day

• Incidence of post-operative complications

  12 months

• Clinical success

  30-day

• Clinical success

  6 months

• Clinical success

  12 months

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Interventions

SETA LATECBA Stent Grafts DEVICE

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.

Also known as: ABK SETA LATECBA, RIK SETA LATECBA

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Immediate suprarenal aorta angulated ≤ 60 degrees relative to the immediate infrarenal neck.
• Common iliac diameter 8 to 20 mm.
• Common iliac length 25 mm
• Common iliac angle 60 degrees
• Not eligible for other standard EVAR surgical procedure

You may not qualify if:

• 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
• 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
• Planned interventional or surgical procedure within 30 days before or after AAA repair.
• Renal dysfunction: creatinine level over 1.7 mg/dl
• Systemic infection or fever over 38°C
• 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)

Sponsors & Collaborators

• Latecba S.A.: lead

Study Sites (1)

Centre Hospitalier Universitaire Sherbrooke

Sherbrooke, Montreal, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• The-Bao Bui, MD

  Centre Hospitalier Universitaire Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ezequiel Klimovsky, MD

CONTACT

54 11 4952 1360; eklimovsky@quid-consulting.com

Francisco Barone, Eng

CONTACT

54 11 49120064; fbarone@latecba.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Open-label, Multicenter, Non-randomized

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 7, 2020
• Study Start: December 11, 2019
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)