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

NCT ID: NCT04220177

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2022-03-31

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SETA LATECBA Stent Grafts

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ABK SETA LATECBA; RIK SETA LATECBA

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

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

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Latecba S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

The-Bao Bui, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Sherbrooke

Locations

Centre Hospitalier Universitaire Sherbrooke

Sherbrooke, Montreal, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ezequiel Klimovsky, MD

Role: CONTACT

eklimovsky@quid-consulting.com

54 11 4952 1360

Francisco Barone, Eng

Role: CONTACT

fbarone@latecba.com

54 11 49120064

Facility Contacts

Guylaine Provencher, MD

Role: primary

819 8206480

Other Identifiers

SETALATECBACAN002

Identifier Type: -

Identifier Source: org_study_id