Abdominal Aortic AneurysmNCT04532450
Outcomes of FEVAR and BEVAR to Treat Secondary Type 1 Endoleak After EVAR: A Prospective Multicentre Study
An observational study of Abdominal Aortic Aneurysm, run by University Paul Sabatier of Toulouse.
Trial summary
Ten percent of the population above 60 years develops an aortic abdominal aneurysm. In case of rupture, this pathology leads to death in more than 70% of the cases. Over the past ten years, Endovascular Aortic Aneurysm Repair (EVAR) has been the most used technique for elective treatment for abdominal aortic aneurysms… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Branched / fenestrated aortic stent graft
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2019
- 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: All patients who developed more than 1 month after initial exclusion of an aortic abdominal aneurysm by a stent graft (EVAR) a proximal endoleak treated by a fenestrated stent graft to exclude a type 1A endoleak and to revascularise the renal arteries, the superior mesenteric artery and the celiac trunk.
Who may be able to join
- All patients who developed after primary endovascular aneurysm repair (EVAR), a secondary type IA endoleak, and received a Fenestrated stent graft as treatment
- All aetiologies leading to the development of this endoleak, any abnormality of the infra-renal stent graft, any aneurysmal evolution of the neck of the infra-renal aneurysm, and of the inter-renal or thoracoabdominal aorta.
- On-label Fenestrated gaft which were approved by the Zenith cook planning centre
Who cannot join
- Endovascular aortic repair<30 days
- Patients treated in emergency for aortic rupture
About this study
Official title: Outcomes of Fenestrated and Branched Stent Grafts to Treat Secondary Type 1 Endoleak After Endovascular Aneurysm Repair : A Prospective Multicentre Study
Ten percent of the population above 60 years develops an aortic abdominal aneurysm. In case of rupture, this pathology leads to death in more than 70% of the cases.
Over the past ten years, Endovascular Aortic Aneurysm Repair (EVAR) has been the most used technique for elective treatment for abdominal aortic aneurysms (AAA) in patients with a favorable anatomy. But despite excellent postoperative results with a significant reduction of mortality , a close follow-up of these patients is mandatory to detect any potential endoleaks particularly in patients with a long-life expectancy.
Read more
Failed Endovascular Infrarenal Aortic Aneurysm Repair (EVAR) with development of a proximal endoleak exposes the patient to the risk of rupture and must be treated. This type of endoleaks are often related to dilatation of the proximal neck of the AAA, and of the suprarenal aorta, making the use of any aortic fixation system, or uncovered stent ineffective. In these cases, open surgical conversion with stent graft removal is possible but at the price of a significant morbidity and mortality.
The alternative is the use of a fenestrated or branched stent graft (F/BEVAR) extending the proximal sealing zone to a non-diseased aorta.
The goal of this study was to evaluate the technical feasibility, early and midterm outcomes of (F/BEVAR) in patients with a proximal endoleak following a standard EVAR.
The investigators performed a multicentre study between January 2010 and December 2019 in 8 French University Centres which included 85 patients with 3 years of post operative follow-up.
Read the detailed description
Between January 2010 and December 2019, all patients (n=85) who developed after EVAR, a secondary type IA endoleak, and received a F/BEVAR stent graft were entered in a prospective multicentre study bringing together 8 French university centres.
Type IA secondary endoleak was defined as an endoleak appearing during follow-up, but absent on computed tomography angiography (CTA) within 30 days of EVAR. All aetiologies leading to the development of this endoleak were recorded in the study, including any abnormality of the infra-renal stent graft, any aneurysmal evolution of the neck of the infra-renal aneurysm, and any aneurysmal evolutionof the inter-renal or thoracoabdominal aorta.
All patients gave their informed consent for the operation. Following the European regulation on data management, the database was anonymised, upon completion.
All patients had a preoperative assessment of cardiac, renal, respiratory function and underwent an ASA physical status classification. All preoperative imaging were performed on <1.5 mm slices.
All F/BEVAR were performed using a COOK Zenith stent graft (Cook Medical Inc. Bloomington, Ind). The number of fenestrations used was based on the preoperative sizing made from 3D-CTA reconstructions. The investigators only used on-label F/BEVARs which were approved by the Zenith cook planning centre.
Procedures were performed under general, epidural or local anaesthesia, depending on the preference of the anesthesiologist, surgeon or patient. Procedures were performed in a conventional operating theatre or a hybrid room as described elsewhere.
General postoperative complications included any cause mortality. Acute kidney injury was defined following the KDIGO criteria , and myocardial infarction according to the generally accepted criteria. Postoperative respiratory complications were defined by the need for mechanical ventilation for more than 48 hours or re-intubation. SCI was classified according to the severity of the American Spinal Injury Association score and stroke was classified according to National Institute of Health Stroke Scale (NIHSS) .
The European Society for Vascular Surgery guidelines were used to define technical success, major adverse events, aneurysm sac changes, endoleak and device integrity .
F/BEVAR procedures were analysed in an intention to treat. A procedure was considered successful if the stent graft was implanted without any Type IA or type III endoleak, and with patent target arteries on peroperative angiography and on CTA or contrast enhanced ultrasound performed within the first week following the procedure. Target artery instability was defined as any branch-related death, rupture, occlusion or reintervention for stenosis, kink, endoleak, or disconnection. Monitoring during follow-up was carried out by CTA, at 3, 6 and 36 months thereafter. Any endovascular or open revision related to the procedure was recorded during follow-up.
Univariate analysis was performed using t-tests for normally distributed continuous variables, and Wilcoxon rank sum test for non-normally distributed continuous variables. Chi-square or Fisher tests was used when appropriate for categorical variables. Time dependent outcomes including patient survival, freedom from reintervention, freedom from endoleak and target arteries patency were reported using Kaplan-Meier time-to-event method. A p-value < .05 was used to assess statistical significance. All analyses were performed with SPSS V26, (IBM Corp.) and Medcalc ®.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Branched / fenestrated aortic stent graft
- Keywords
- Abdominal aortic aneurysm, Failed EVAR, Type 1A endoleak, Fenestrated stent graft, EVAR
- 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.
Branched / fenestrated aortic stent graftDevice
Endovascular repair of an aortic aneurysm with a branched/fenestrated stent graft to revascularise all visceral arteries together with exclusion of the aortic aneurysm.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of technical success
A procedure was considered successful if the fenestrated stent graft was implanted without any Type IA or type III endoleak, and with patent target arteries on peroperative angiography and on CTA or contrast enhanced ultrasound
Measured: Up to 7 days following the procedure
Rate of general postoperative complications
Any cause mortality. Acute kidney injury defined by the KDIGO criteria, myocardial infarction, postoperative respiratory complications were defined by the need for mechanical ventilation for more than 48 hours or re-intubation. paraparesis or paraplegia according to the American Spinal Injury Association score and stroke according to National Institute of Health Stroke Scale (NIHSS) .
Measured: Up to 31 days following the procedure
Rate of late complications
Any complication occurring during follow-up.
Measured: 36 months after the procedure
Change in the aortic aneurysm diameter
Aneurysm sac diameter: any change > 5 mm
Measured: 36 months after the procedure
Rate of unstable branches to target artery
Any branch to target artery-related death, rupture, occlusion or reintervention for stenosis, kink, endoleak, or disconnection.
Measured: 36 months after the procedure
Rate of endoleak or F/B stent graft abnormality.
Any endoleak, type IA, Type IB, Type II or any F/B stent graft abnormality
Measured: 36 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Jan 2010
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurélien Hostalrich, University Paul Sabatier of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532450
- Sponsor's protocol ID
- UPaulSabatierToulouse
- Status last verified
- Aug 2020
- First submitted
- 9 Jul 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schermerhorn ML, Buck DB, O'Malley AJ, Curran T, McCallum JC, Darling J, Landon BE. Long-Term Outcomes of Abdominal Aortic Aneurysm in the Medicare Population. N Engl J Med. 2015 Jul 23;373(4):328-38. doi: 10.1056/NEJMoa1405778.
PubMed 26200979Katsargyris A, Yazar O, Oikonomou K, Bekkema F, Tielliu I, Verhoeven EL. Fenestrated stent-grafts for salvage of prior endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2013 Jul;46(1):49-56. doi: 10.1016/j.ejvs.2013.03.028. Epub 2013 May 1.
PubMed 23642523Schanzer A, Beck AW, Eagleton M, Farber MA, Oderich G, Schneider D, Sweet MP, Crawford A, Timaran C; U.S. Multicenter Fenestrated/Branched Aortic Research Consortium. Results of fenestrated and branched endovascular aortic aneurysm repair after failed infrarenal endovascular aortic aneurysm repair. J Vasc Surg. 2020 Sep;72(3):849-858. doi: 10.1016/j.jvs.2019.11.026. Epub 2020 Mar 3.
PubMed 32144014Martin Z, Greenberg RK, Mastracci TM, Eagleton MJ, O'Callaghan A, Bena J. Late rescue of proximal endograft failure using fenestrated and branched devices. J Vasc Surg. 2014 Jun;59(6):1479-87. doi: 10.1016/j.jvs.2013.12.028. Epub 2014 Jan 29.
PubMed 24486036Goudeketting SR, Fung Kon Jin PHP, Unlu C, de Vries JPM. Systematic review and meta-analysis of elective and urgent late open conversion after failed endovascular aneurysm repair. J Vasc Surg. 2019 Aug;70(2):615-628.e7. doi: 10.1016/j.jvs.2018.11.022. Epub 2019 Apr 5.
PubMed 30956006Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
PubMed 29268916Hostalrich A, Mesnard T, Soler R, Girardet P, Kaladji A, Jean Baptiste E, Malikov S, Reix T, Ricco JB, Chaufour X; Association Universitaire de Recherche en Chirurgie (AURC). Prospective Multicentre Cohort Study of Fenestrated and Branched Endografts After Failed Endovascular Infrarenal Aortic Aneurysm Repair with Type Ia Endoleak. Eur J Vasc Endovasc Surg. 2021 Oct;62(4):540-548. doi: 10.1016/j.ejvs.2021.06.019. Epub 2021 Aug 5.
PubMed 34364770
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Fenestrated and Branched Stent Grafts to Treat Secondary Type 1 Endoleak After Endovascular Aneurysm Repair : A Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT04532450
- Acronym / sponsor ID
- UPaulSabatierToulouse
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal aortic aneurysm, Failed EVAR, Type 1A endoleak, Fenestrated stent graft, EVAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Aug 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.
Ten percent of the population above 60 years develops an aortic abdominal aneurysm. In case of rupture, this pathology leads to death in more than 70% of the cases.
Over the past ten years, Endovascular Aortic Aneurysm Repair (EVAR) has been the most used technique for elective treatment for abdominal aortic aneurysms (AAA) in patients with a favorable anatomy. But despite excellent postoperative results with a significant reduction of mortality , a close follow-up of these patients is mandatory to detect any potential endoleaks particularly in patients with a long-life expectancy.
Failed Endovascular Infrarenal Aortic Aneurysm Repair (EVAR) with development of a proximal endoleak exposes the patient to the risk of rupture and must be treated. This type of endoleaks are often related to dilatation of the proximal neck of the AAA, and of the suprarenal aorta, making the use of any aortic fixation system, or uncovered stent ineffective. In these cases, open surgical conversion with stent graft removal is possible but at the price of a significant morbidity and mortality.
The alternative is the use of a fenestrated or branched stent graft (F/BEVAR) extending the proximal sealing zone to a non-diseased aorta.
The goal of this study was to evaluate the technical feasibility, early and midterm outcomes of (F/BEVAR) in patients with a proximal endoleak following a standard EVAR.
The investigators performed a multicentre study between January 2010 and December 2019 in 8 French University Centres which included 85 patients with 3 years of post operative follow-up.
Detailed description
Between January 2010 and December 2019, all patients (n=85) who developed after EVAR, a secondary type IA endoleak, and received a F/BEVAR stent graft were entered in a prospective multicentre study bringing together 8 French university centres.
Type IA secondary endoleak was defined as an endoleak appearing during follow-up, but absent on computed tomography angiography (CTA) within 30 days of EVAR. All aetiologies leading to the development of this endoleak were recorded in the study, including any abnormality of the infra-renal stent graft, any aneurysmal evolution of the neck of the infra-renal aneurysm, and any aneurysmal evolutionof the inter-renal or thoracoabdominal aorta.
All patients gave their informed consent for the operation. Following the European regulation on data management, the database was anonymised, upon completion.
All patients had a preoperative assessment of cardiac, renal, respiratory function and underwent an ASA physical status classification. All preoperative imaging were performed on <1.5 mm slices.
All F/BEVAR were performed using a COOK Zenith stent graft (Cook Medical Inc. Bloomington, Ind). The number of fenestrations used was based on the preoperative sizing made from 3D-CTA reconstructions. The investigators only used on-label F/BEVARs which were approved by the Zenith cook planning centre.
Procedures were performed under general, epidural or local anaesthesia, depending on the preference of the anesthesiologist, surgeon or patient. Procedures were performed in a conventional operating theatre or a hybrid room as described elsewhere.
General postoperative complications included any cause mortality. Acute kidney injury was defined following the KDIGO criteria , and myocardial infarction according to the generally accepted criteria. Postoperative respiratory complications were defined by the need for mechanical ventilation for more than 48 hours or re-intubation. SCI was classified according to the severity of the American Spinal Injury Association score and stroke was classified according to National Institute of Health Stroke Scale (NIHSS) .
The European Society for Vascular Surgery guidelines were used to define technical success, major adverse events, aneurysm sac changes, endoleak and device integrity .
F/BEVAR procedures were analysed in an intention to treat. A procedure was considered successful if the stent graft was implanted without any Type IA or type III endoleak, and with patent target arteries on peroperative angiography and on CTA or contrast enhanced ultrasound performed within the first week following the procedure. Target artery instability was defined as any branch-related death, rupture, occlusion or reintervention for stenosis, kink, endoleak, or disconnection. Monitoring during follow-up was carried out by CTA, at 3, 6 and 36 months thereafter. Any endovascular or open revision related to the procedure was recorded during follow-up.
Univariate analysis was performed using t-tests for normally distributed continuous variables, and Wilcoxon rank sum test for non-normally distributed continuous variables. Chi-square or Fisher tests was used when appropriate for categorical variables. Time dependent outcomes including patient survival, freedom from reintervention, freedom from endoleak and target arteries patency were reported using Kaplan-Meier time-to-event method. A p-value < .05 was used to assess statistical significance. All analyses were performed with SPSS V26, (IBM Corp.) and Medcalc ®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who developed more than 1 month after initial exclusion of an aortic abdominal aneurysm by a stent graft (EVAR) a proximal endoleak treated by a fenestrated stent graft to exclude a type 1A endoleak and to revascularise the renal arteries, the superior mesenteric artery and the celiac trunk.
Key inclusion criteria (3 listed)
- All patients who developed after primary endovascular aneurysm repair (EVAR), a secondary type IA endoleak, and received a Fenestrated stent graft as treatment
- All aetiologies leading to the development of this endoleak, any abnormality of the infra-renal stent graft, any aneurysmal evolution of the neck of the infra-renal aneurysm, and of the inter-renal or thoracoabdominal aorta.
- On-label Fenestrated gaft which were approved by the Zenith cook planning centre
Key exclusion criteria (2 listed)
- Endovascular aortic repair<30 days
- Patients treated in emergency for aortic rupture
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 |
|---|---|---|
| Branched / fenestrated aortic stent graftEndovascular repair of an aortic aneurysm with a branched/fenestrated stent graft to revascularise all visceral arteries together with exclusion of the aortic aneurysm. | Device | – |
Primary outcome
Rate of technical success
Time frame: Up to 7 days following the procedure
A procedure was considered successful if the fenestrated stent graft was implanted without any Type IA or type III endoleak, and with patent target arteries on peroperative angiography and on CTA or contrast enhanced ultrasound
Rate of general postoperative complications
Time frame: Up to 31 days following the procedure
Any cause mortality. Acute kidney injury defined by the KDIGO criteria, myocardial infarction, postoperative respiratory complications were defined by the need for mechanical ventilation for more than 48 hours or re-intubation. paraparesis or paraplegia according to the American Spinal Injury Association score and stroke according to National Institute of Health Stroke Scale (NIHSS) .
Rate of late complications
Time frame: 36 months after the procedure
Any complication occurring during follow-up.
Change in the aortic aneurysm diameter
Time frame: 36 months after the procedure
Aneurysm sac diameter: any change > 5 mm
Rate of unstable branches to target artery
Time frame: 36 months after the procedure
Any branch to target artery-related death, rupture, occlusion or reintervention for stenosis, kink, endoleak, or disconnection.
Rate of endoleak or F/B stent graft abnormality.
Time frame: 36 months after the procedure
Any endoleak, type IA, Type IB, Type II or any F/B stent graft abnormality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Background: PubMed 26200979Schermerhorn ML, Buck DB, O'Malley AJ, Curran T, McCallum JC, Darling J, Landon BE. Long-Term Outcomes of Abdominal Aortic Aneurysm in the Medicare Population. N Engl J Med. 2015 Jul 23;373(4):328-38. doi: 10.1056/NEJMoa1405778.
- Background: PubMed 23642523Katsargyris A, Yazar O, Oikonomou K, Bekkema F, Tielliu I, Verhoeven EL. Fenestrated stent-grafts for salvage of prior endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2013 Jul;46(1):49-56. doi: 10.1016/j.ejvs.2013.03.028. Epub 2013 May 1.
- Background: PubMed 32144014Schanzer A, Beck AW, Eagleton M, Farber MA, Oderich G, Schneider D, Sweet MP, Crawford A, Timaran C; U.S. Multicenter Fenestrated/Branched Aortic Research Consortium. Results of fenestrated and branched endovascular aortic aneurysm repair after failed infrarenal endovascular aortic aneurysm repair. J Vasc Surg. 2020 Sep;72(3):849-858. doi: 10.1016/j.jvs.2019.11.026. Epub 2020 Mar 3.
- Background: PubMed 24486036Martin Z, Greenberg RK, Mastracci TM, Eagleton MJ, O'Callaghan A, Bena J. Late rescue of proximal endograft failure using fenestrated and branched devices. J Vasc Surg. 2014 Jun;59(6):1479-87. doi: 10.1016/j.jvs.2013.12.028. Epub 2014 Jan 29.
- Background: PubMed 30956006Goudeketting SR, Fung Kon Jin PHP, Unlu C, de Vries JPM. Systematic review and meta-analysis of elective and urgent late open conversion after failed endovascular aneurysm repair. J Vasc Surg. 2019 Aug;70(2):615-628.e7. doi: 10.1016/j.jvs.2018.11.022. Epub 2019 Apr 5.
- Results publication: PubMed 29268916Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
- Derived from this study: PubMed 34364770Hostalrich A, Mesnard T, Soler R, Girardet P, Kaladji A, Jean Baptiste E, Malikov S, Reix T, Ricco JB, Chaufour X; Association Universitaire de Recherche en Chirurgie (AURC). Prospective Multicentre Cohort Study of Fenestrated and Branched Endografts After Failed Endovascular Infrarenal Aortic Aneurysm Repair with Type Ia Endoleak. Eur J Vasc Endovasc Surg. 2021 Oct;62(4):540-548. doi: 10.1016/j.ejvs.2021.06.019. Epub 2021 Aug 5.
- 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 record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by University Paul Sabatier of Toulouse.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of technical success (time frame: Up to 7 days following the procedure). The study lists 6 primary outcomes in all. 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 NCT04532450, which also lists 7 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 31 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.