Thoracic Aortic AneurysmNCT05309707
ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
An observational study of Thoracic Aortic Aneurysm and Thoracic Aortic Dissection, run by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery at 1 site in Spain.
Trial summary
The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Stent-Graft Endoleak
- What is being tested?
- Endovascular exclusion
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 31 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with aortic arch pathologies (aneurysm, pseudoanerysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0.
Who may be able to join
- Patient is between 18 and 90 years old
- Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0.
- Patient must be available for the appropriate follow-up times for the duration of the study
- Informed consent signed.
Who cannot join
- Patient less than 18 years old or more than 90 years old.
- Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium)
- Patient has systemic infection or suspected systemic infection
- Patient has thrombocytopenia (platelet count < 150000/µl)
- Patient has untreated hyperthyroidism
- Patient has a progressive or untreated malignancy.
Show all 9Show fewer
- Patient is pregnant or breastfeeding.
- Patient has a life expectancy of less than 1 year.
- Not informed consent signed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Spanish society for Angiology and Vascular Surgery
Madrid, 28006
Enrique M San Norberto, MD, PhD, MsC, PGCert, 00346983420000 ext. 86962, esannorberto@hotmail.com
Manuel Alonso Pérez, MD, PhD
About this study
The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.
The secondary objective is to evaluate the safety and clinical performance of the studied devices.
Read the detailed description
In this study patients will be observed, who receive a branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) for the endovascular treatment of aortic arch pathologies with proximal landing at zone 0. The devices will be implanted at the discretion of the treating physician.
Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the branch stent graft systems for aortic arch (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®). Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.
The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.
- Conditions
- Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Stent-Graft Endoleak, Stent-Graft Stenosis, Intramural Hematoma, Aortic Diseases
- Being tested
- Endovascular exclusion
- Keywords
- Aorta, Thoracic aortic aneurysm, Thoracic aorta dissection, Endovascular repair
- Medical subject headings
- Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta, Aortic Diseases, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular exclusionDevice
Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.
| Study group | Role | What they receive |
|---|---|---|
| Patients with aortic arch pathologies treated by branch stent graft systems | Patients with aortic arch pathologies treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0. Receives: Device: Endovascular exclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Rate of all-cause mortality
Measured: 30 days
Secondary outcomes (21)
Mortality
Rate of all-cause mortality in peri-operative periods (all related interventions)
Measured: 24 hours
Mortality
Rate of all-cause mortality
Measured: 3-6, 12, 24, 36, 48, 60 months
Rupture
Rate of patients with aneurysm rupture
Measured: 3-6, 12, 24, 36, 48, 60 months
Major Adverse Events (MAE)
Rate of patients with major adverse events (aneurysm related death, aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), new disabling stroke, visceral ischemia (bowel ischemia with surgery or submission to ICU or bowel necrosis with surgery or submission to ICU), new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, new permanent paraplegia, new permanent paraparesis, lower limb ischemia (increase in Rutherford classification) (product-related, procedure-related, aneurysm-related)
Measured: prior to discharge, 30 days, 3-6, 12, 24, 36, 48, 60 months
Number of interventions
Rate of interventions in peri-operative periods (all related interventions until index procedure)
Measured: Perioperative
Delivery time
Rate of time intervals the branched-stent graft implantation
Measured: Perioperative
Reintervention
Rate of reinterventions
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Endoleak
Rate of patients with endoleak
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Proximal intercomponent separation
Rate of patients with intercomponent separation at the proximal end of the Nexus stent-graft system > 10 mm
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Integrity
Rate of patients with loss of device integrity (stent fracture and tear in graft material and suture break)
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Kinking
Rate of patients with stent graft or bridging stent graft kinking
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Primary patency
Rate of primary patency of bridging stents
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary patency
Rate of secondary patency of bridging stents
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Infection
Rate of patients with stent graft infection
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Primary technical success
Rate of patients with primary technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated within 24 h after the index procedure.
Successful introduction and deployment of the multibranch stent-graft systems in the absence of:
Surgical conversion Mortality Reintervention Unplanned branch vessel occlusion (post-operative occlusion)
Including:
Secure proximal and distal fixation Patent treated branch vessels
Measured: 24 hours
Technical success
Rate of patients with technical success. Technical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure.
Measured: 24 hours
Primary clinical success
Rate of patients with primary clinical success.
Primary clinical success is reported on an intent-to-treat basis and is reached if the following criteria are fulfilled at the time of follow-up starting at 12 months follow-up:
Successful deployment of the endovascular devices at the intended location in the absence of:
Death as result of aneurysm-related treatment Conversion to open repair Reintervention after index procedure Occlusion of treated branch vessels Type I or III endoleak Increasing aneurysm size Aneurysm rupture
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Clinical success
Rate of patients with clinical success. Clinical success is achieved in case all above mentioned criteria are fulfilled, however, an additional unplanned endovascular or surgical procedure is necessitated after the index procedure.
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Stable aneurysm size
Rate of patients with stable aneurysm size
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Decreasing
Rate of patients with decreasing (<5mm) aneurysm size
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Increasing
Rate of patients with increasing (>5mm) aneurysm size
Measured: 30 days, 3-6, 12, 24, 36, 48, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309707
- Sponsor's protocol ID
- 2022-03
- Status last verified
- Mar 2022
- First submitted
- 24 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data analyzed by core lab
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
- ClinicalTrials.gov ID
- NCT05309707
- Acronym / sponsor ID
- 2022-03
- Conditions
- Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Stent-Graft Endoleak, Stent-Graft Stenosis, Intramural Hematoma, Aortic Diseases
- Keywords
- Aorta, Thoracic aortic aneurysm, Thoracic aorta dissection, Endovascular repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular SurgeryResearch network
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Apr 2022 (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.
The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.
The secondary objective is to evaluate the safety and clinical performance of the studied devices.
Detailed description
In this study patients will be observed, who receive a branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) for the endovascular treatment of aortic arch pathologies with proximal landing at zone 0. The devices will be implanted at the discretion of the treating physician.
Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the branch stent graft systems for aortic arch (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®). Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.
The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with aortic arch pathologies treated by branch stent graft systems | – | Device: Endovascular exclusionPatients with aortic arch pathologies treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with aortic arch pathologies (aneurysm, pseudoanerysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0.
Key inclusion criteria (4 listed)
- Patient is between 18 and 90 years old
- Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0.
- Patient must be available for the appropriate follow-up times for the duration of the study
- Informed consent signed.
Key exclusion criteria (9 listed)
- Patient less than 18 years old or more than 90 years old.
- Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium)
- Patient has systemic infection or suspected systemic infection
- Patient has thrombocytopenia (platelet count < 150000/µl)
- Patient has untreated hyperthyroidism
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 |
|---|---|---|
| Endovascular exclusionEndovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0. | Device | Patients with aortic arch pathologies treated by branch stent graft systems |
Primary outcome
Mortality
Time frame: 30 days
Rate of all-cause mortality
21 secondary outcomes
Mortality
Time frame: 24 hours
Mortality
Time frame: 3-6, 12, 24, 36, 48, 60 months
Rupture
Time frame: 3-6, 12, 24, 36, 48, 60 months
Major Adverse Events (MAE)
Time frame: prior to discharge, 30 days, 3-6, 12, 24, 36, 48, 60 months
Number of interventions
Time frame: Perioperative
Delivery time
Time frame: Perioperative
Reintervention
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Endoleak
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Proximal intercomponent separation
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Integrity
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Kinking
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Primary patency
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Secondary patency
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Infection
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Primary technical success
Time frame: 24 hours
Technical success
Time frame: 24 hours
Primary clinical success
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Clinical success
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Stable aneurysm size
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Decreasing
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Increasing
Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Spanish Society for Angiology and Vascular SurgeryLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data analyzed by core lab
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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.
Spanish society for Angiology and Vascular Surgery
Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Aneurysm and Thoracic Aortic Dissection, run by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery at 1 site in Spain.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Apr 2022. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). 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 4 Apr 2022.