Aortic AneurysmNCT04100499
Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR
An observational study of Aortic Aneurysm and Thoracic Aortic Aneurysm, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR. The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Aneurysm, Thoracic Aortic Aneurysm
- What is being tested?
- ESAR (Endosutured Aneurysm Repair)
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 31 Dec 2019to 19 Nov 2022
- How long will I take part?
- 36 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with abdominal or thoracic aneurysms.
Who may be able to join
- All consecutive patients with adjunctive use of EndoAnchors during or after EVAR and TEVAR
Who cannot join
- Patients that don't want te receive any repair for their disease
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vascular Surgery Department
Madrid, 28034
Andrés Reyes, Consultant, +34629586239, cauzaza@hotmail.com
About this study
Official title: Evaluation of Adjunctive Use of EndoAnchors During of After EVAR and TEVAR
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR.
The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)
Read the detailed description
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed designed to improve the Endovascular aortic repair. This device is described to mimic an open surgical anastomosis during or after EVAR/TEVAR.
The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study), these outcomes will be described in terms of type IA Endoleaks, migration and sac regression.
- Conditions
- Aortic Aneurysm, Thoracic Aortic Aneurysm
- Being tested
- ESAR (Endosutured Aneurysm Repair)
- Keywords
- Endoanchors, EVAR, TEVAR
- Medical subject headings
- Aortic Aneurysm, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESAR (Endosutured Aneurysm Repair)Device
EndoAnchors adjunctive therapy for EVAR and TEVAR
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants with type IA Endoleaks
Absence of type IA Endoleaks during follow-up
Measured: Three years
Secondary outcomes (2)
Rate of participants with Endograft Migration
Analysis of Endograft migration during follow-up
Measured: Three years
Rate of participants with Sac regression
Analysis of Sac regression during follow-up
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start31 Dec 2019
- Primary completion31 Dec 2020
- Study completion19 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés Reyes Valdivia, Hospital Universitario Ramon y Cajal
- Investigators
- Andres Reyes Valdivia, Consultant, Principal investigator, Vascular Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100499
- Sponsor's protocol ID
- 187/19
- Status last verified
- Feb 2021
- First submitted
- 19 Sep 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Reyes Valdivia A, Duque Santos A, Pitoulias G, Aracil Sanus E, Ocana Guaita J, Gandarias Zuniga C. Predictors of inadequate EndoAnchors aortic wall penetration for the Endosutured therapy in hostile neck patients. J Cardiovasc Surg (Torino). 2020 Dec;61(6):738-744. doi: 10.23736/S0021-9509.20.11248-5. Epub 2020 Jun 19.
PubMed 32558525Reyes Valdivia A, Busto Suarez S, Duque Santos A, Zanabili Al-Sibbai AA, Gandarias Zuniga C, Chaudhuri A. Evaluation of EndoAnchor Aortic Wall Penetration After Thoracic Endovascular Aortic Repair. J Endovasc Ther. 2020 Apr;27(2):240-247. doi: 10.1177/1526602820907564.
PubMed 32186262Reyes Valdivia A, Milner R, Heijmen R, Riambau V, Rousseau H, Tinelli G, Kotelis D, Zanabili Al-Sibbai AA, Pitoulias G, Zuniga CG, de Beaufort HWL, Panagiotis D, Chaudhuri A. Mid-term outcomes of the use of endoanchors during thoracic endovascular aortic repair in multicentre analysis. Vascular. 2023 Jun;31(3):455-462. doi: 10.1177/17085381221076320. Epub 2022 Feb 27.
PubMed 35225085Reyes Valdivia A, Chaudhuri A, Milner R, Pratesi G, Reijnen MM, Tinelli G, Schuurmann R, Barbante M, Babrowski TA, Pitoulias G, Tshomba Y, Gandarias C, Badawy A, de Vries JP. Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry. Vascular. 2022 Feb;30(1):27-37. doi: 10.1177/1708538121992596. Epub 2021 Feb 10.
PubMed 33568007
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adjunctive Use of EndoAnchors During of After EVAR and TEVAR
- ClinicalTrials.gov ID
- NCT04100499
- Acronym / sponsor ID
- 187/19
- Conditions
- Aortic Aneurysm, Thoracic Aortic Aneurysm
- Keywords
- Endoanchors, EVAR, TEVAR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 19 Nov 2022 (estimated)
- First posted
- 24 Sep 2019 (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.
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR.
The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)
Detailed description
EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed designed to improve the Endovascular aortic repair. This device is described to mimic an open surgical anastomosis during or after EVAR/TEVAR.
The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study), these outcomes will be described in terms of type IA Endoleaks, migration and sac regression.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 36 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with abdominal or thoracic aneurysms.
Key inclusion criteria (1 listed)
- All consecutive patients with adjunctive use of EndoAnchors during or after EVAR and TEVAR
Key exclusion criteria (1 listed)
- Patients that don't want te receive any repair for their disease
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 |
|---|---|---|
| ESAR (Endosutured Aneurysm Repair)EndoAnchors adjunctive therapy for EVAR and TEVAR | Device | – |
Primary outcome
Rate of participants with type IA Endoleaks
Time frame: Three years
Absence of type IA Endoleaks during follow-up
2 secondary outcomes
Rate of participants with Endograft Migration
Time frame: Three years
Rate of participants with Sac regression
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Background: PubMed 32558525Reyes Valdivia A, Duque Santos A, Pitoulias G, Aracil Sanus E, Ocana Guaita J, Gandarias Zuniga C. Predictors of inadequate EndoAnchors aortic wall penetration for the Endosutured therapy in hostile neck patients. J Cardiovasc Surg (Torino). 2020 Dec;61(6):738-744. doi: 10.23736/S0021-9509.20.11248-5. Epub 2020 Jun 19.
- Background: PubMed 32186262Reyes Valdivia A, Busto Suarez S, Duque Santos A, Zanabili Al-Sibbai AA, Gandarias Zuniga C, Chaudhuri A. Evaluation of EndoAnchor Aortic Wall Penetration After Thoracic Endovascular Aortic Repair. J Endovasc Ther. 2020 Apr;27(2):240-247. doi: 10.1177/1526602820907564.
- Derived from this study: PubMed 35225085Reyes Valdivia A, Milner R, Heijmen R, Riambau V, Rousseau H, Tinelli G, Kotelis D, Zanabili Al-Sibbai AA, Pitoulias G, Zuniga CG, de Beaufort HWL, Panagiotis D, Chaudhuri A. Mid-term outcomes of the use of endoanchors during thoracic endovascular aortic repair in multicentre analysis. Vascular. 2023 Jun;31(3):455-462. doi: 10.1177/17085381221076320. Epub 2022 Feb 27.
- Derived from this study: PubMed 33568007Reyes Valdivia A, Chaudhuri A, Milner R, Pratesi G, Reijnen MM, Tinelli G, Schuurmann R, Barbante M, Babrowski TA, Pitoulias G, Tshomba Y, Gandarias C, Badawy A, de Vries JP. Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry. Vascular. 2022 Feb;30(1):27-37. doi: 10.1177/1708538121992596. Epub 2021 Feb 10.
- Individual participant dataSharing planned: Undecided
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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.
Andres Reyes Valdivia, Consultant principal investigator
Vascular Surgery Department
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 Aortic Aneurysm and Thoracic Aortic Aneurysm, run by Hospital Universitario Ramon y Cajal 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 1 inclusion and 1 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 11 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andres Reyes Valdivia, Consultant (+34629586239, cauzaza@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants with type IA Endoleaks (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04100499, which also lists 4 linked publications.
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 11 Feb 2021.