Abdominal Aortic AneurysmNCT04220177
Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAA
A study testing SETA LATECBA Stent Grafts in people with Abdominal Aortic Aneurysm, run by Latecba S.A. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- SETA LATECBA Stent Grafts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 11 Dec 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- General Exclusion Criteria
- 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
- Medical Exclusion Criteria
- Previous treatment of AAA
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- 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
- AAA Anatomy Exclusion Criteria
- Significant occlusive disease, tortuosity, or calcification.
- 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.
- 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.
- Iliac artery distal fixation site < 10 mm in length. w) Indispensable inferior mesenteric artery (IMA)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Sherbrooke
Sherbrooke, Montreal
Guylaine Provencher, MD, 819 8206480
About this study
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).
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.
Read the 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
- Being tested
- SETA LATECBA Stent Grafts
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SETA LATECBA Stent GraftsDevice
Also called ABK SETA LATECBA, RIK SETA LATECBA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SETA LATECBA Stent Grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
SAFETY: mortality
percentage of died subjects
Measured: 30-day
Secondary outcomes (6)
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
Measured: 30-day
Incidence of post-operative complications
Complications of aneurysm repair followed by secondary interventions
Measured: 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,
Measured: 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
Measured: 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
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start11 Dec 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Open-label, Multicenter, Non-randomized
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latecba S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- The-Bao Bui, MD, Principal investigator, Centre Hospitalier Universitaire Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220177
- Sponsor's protocol ID
- SETALATECBACAN002
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2020
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04220177
- Acronym / sponsor ID
- SETALATECBACAN002
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Latecba S.A.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Open-label, Multicenter, Non-randomized
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Device: SETA LATECBA Stent GraftsSETA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 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
Key exclusion criteria (18 listed)
- General Exclusion Criteria
- Medical Exclusion Criteria
- Previous treatment of AAA
- Known allergy to polyester, stainless steel, nitinol and or gold, teflon, nylon,
- Known anaphylactic reaction to contrast media.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SETA LATECBA Stent GraftsAlso: ABK SETA LATECBA, RIK SETA LATECBAABK 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. | Device | treatment arm |
Primary outcome
EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan)
Time frame: 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
Time frame: 30-day
percentage of died subjects
6 secondary outcomes
SAFETY: Major Adverse Events
Time frame: 30-day
Incidence of post-operative complications
Time frame: 12 months
Clinical success
Time frame: 30-day
Clinical success
Time frame: 6 months
Clinical success
Time frame: 12 months
Technical Success of stent-graft implantation and delivery system usage
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The-Bao Bui, MD principal investigator
Centre Hospitalier Universitaire Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SETA LATECBA Stent Grafts in people with Abdominal Aortic Aneurysm, run by Latecba S.A. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ezequiel Klimovsky, MD (54 11 4952 1360, eklimovsky@quid-consulting.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.