Thoracic Aortic AneurysmNCT04663074
Intravascular Ultrasound (IVUS) in Complex Aortic Endovascular Interventions
An observational study of Thoracic Aortic Aneurysm, run by University Hospital Muenster at 6 sites in 4 countries.
Trial summary
The study aims to investigate the applicability of intravascular ultrasound (IVUS) in the endovascular therapy of juxta-, supra- and thoracoabdominal aortic aneurysms. The focus of the study is on the intraoperative and postoperative evaluation of the geometric data of bridging stentgrafts in terms of patency… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thoracic Aortic Aneurysm
- How many people
- 80 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 22 May 2020to 22 May 2023
- How long will I take part?
- 5 Years
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated by BEVAR/CHEVAR/FEVAR due to a thoracoabdominal aneurysm,
Who may be able to join
- Age over 18 years
- Elective or emergency treatment of an aortic aneurysm with a branched or fenestrated stent graft or with the aid of parallel stent grafts´(chimney)
- Patient capable of giving informed consent
Who cannot join
- Patients who are already participating in another study
- child bearing or breast feeding females
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany2 sites
Klinik für Gefäßchirurgie, St. Franziskus-Hospital
Münster
Muenster University Hospital
Münster
Italy2 sites
Vascualar Surgery, Nocsae Nuovo Ospedale Civile di Baggiovara St. Agostiono Estense
Modena
Vascular and Endovascular Surgery Division, Padua University
Padua
About this study
Official title: Prospective Register of Anatomical / Geometric Data Obtained by Intravascular Ultrasound (IVUS) Examinatio´n of Bridging Stent Grafts in Complex Aortic Interventions
The study aims to investigate the applicability of intravascular ultrasound (IVUS) in the endovascular therapy of juxta-, supra- and thoracoabdominal aortic aneurysms.
The focus of the study is on the intraoperative and postoperative evaluation of the geometric data of bridging stentgrafts in terms of patency, occurrence of stenosis and/or kinking.
Read the detailed description
Intravascular ultrasound (IVUS) is an already validated diagnostic method increasingly use in endovascular interventions. In contrast to conventional digital subtraction angiography (DSA), the IVUS provides in vivo real-time vessel images. Furthermore, its accuracy has been examined in histological studies, which could report of a good correlation regarding the vessel diameters (Jin ZG et al. Int J Cardiovasc Imaging. 2017 Feb; 33 (2): 153-160.).
Stenosis and/or kinkings of stents or stentgrafts as well as their fully expansion and morphology can be assessed with the use of IVUS.
The IVUS has already been used successfully in the context of endovascular treatment of infrarenal aortic aneurysms (Endovascular Aortic Repair or EVAR). Here, the IVUS has proven to be a valuable diagnostic instrument to examine the anatomy of the inserted stent grafts intraoperatively and to detect any abnormalities. In addition, the use of IVUS led to a significant reduction in the use of iodine-containing contrast media and radiation exposure as part of these complex endovascular interventions (Pecoraro F et al. Ann Vasc Surg. 2019 Apr; 56: 209-215.).
In the endovascular therapy of thoracoabdominal as well as suprarenal and juxtarenal aortic aneurysms, stent grafts with recesses (windows - Fenestrated EVAR or FEVAR) or side arms (branches - Branched EVAR or BEVAR) for the renovisceral vessels (truncus coeliacus, superior mesenteric artery and renal arteries) are implanted. In exceptional cases, the renovisceral vessels are supplied with stent grafts that are implanted in parallel to the aortic stent grafts (Chimney-Technique). These branches or windows are then connected to the corresponding target vessels via a bridging stent graft. The patency and anatomy of the bridging stent grafts are usually checked intraoperatively by angiography. The dynamics of the contrast agent flow and the X-ray images of the framework of the stent graft help in assessing their patency as well as the absence of structural problems.
The Computed Tomographic Angiography (CTA) is considered the gold standard as diagnostic method to assess the patency and anatomy of the stentgrafts postoperatively. This diagnostic method bares with it the exposure to relevant radiation dose as well as to contrast media. However, CTA scans do not provide in vivo real-time vessel images.
Furthermore, in case of pathological findings a new intervention may be necessary. The IVUS technique overcomes these issues due to its low invasiveness and its possible use during the index procedure. This can lead to the immediate identification of eventual structural problems of the bridging stent grafts which can jeopardize their patency and to correct them already during the index procedure.
The use of the IVUS during FEVAR, BEVAR and CHEVAR has already been implemented in our clinical routine. At our knowledge, a prospective collection of anatomical-geometric data by IVUS in complex endovascular treatments of complex aortic aneurysm has not been yet reported.
The aim of the current study is the retrospective evaluation of the anatomical-geometric data already collected by IVUS as well as the prospective collection of new data regarding the patency and anatomy of bridging stent grafts.
- Conditions
- Thoracic Aortic Aneurysm
- Being tested
- IVUS control
- Keywords
- Intravascular ultrasound, bridging stentgraft, BEVAR, EVAR, IVUS
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS controlDiagnostic test
Also called Volcano Philips
Intravascular Control of the bridging stentgrafts during branched EVAR
| Study group | Role | What they receive |
|---|---|---|
| IVUS Group | Patients treated by BEVAR/CHEVAR/FEVAR due to a thoracoabdominal aneurysm. Receives: Diagnostic Test: IVUS control |
What is being measured
The primary outcome is the main question the study is designed to answer.
bSG patency
Patency of the bridging stentgraft
Measured: 5 years
Secondary outcomes (1)
Geometrical changes
Geometrical changes of the bridging stentgrafts during follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start22 May 2020
- Primary completion22 May 2022
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- 80 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Oberhuber, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663074
- Sponsor's protocol ID
- 01_2020
- Status last verified
- May 2022
- First submitted
- 3 Dec 2020
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jin ZG, Zhang ZQ, Jing LM, Wei YJ, Zhang J, Luo JP, Yang SL, Ma DX, Liu Y, Han W, Yang Y, Liu HL. Correlation between dual-axis rotational coronary angiography and intravascular ultrasound in a coronary lesion assessment. Int J Cardiovasc Imaging. 2017 Feb;33(2):153-160. doi: 10.1007/s10554-016-0999-5. Epub 2016 Oct 11.
PubMed 27730313Pecoraro F, Bracale UM, Farina A, Badalamenti G, Ferlito F, Lachat M, Dinoto E, Asti V, Bajardi G. Single-Center Experience and Preliminary Results of Intravascular Ultrasound in Endovascular Aneurysm Repair. Ann Vasc Surg. 2019 Apr;56:209-215. doi: 10.1016/j.avsg.2018.09.016. Epub 2018 Nov 27.
PubMed 30500656Georgiadis GS, van Herwaarden JA, Antoniou GA, Hazenberg CE, Giannoukas AD, Lazarides MK, Moll FL. Systematic Review of Off-the-Shelf or Physician-Modified Fenestrated and Branched Endografts. J Endovasc Ther. 2016 Feb;23(1):98-109. doi: 10.1177/1526602815611887. Epub 2015 Oct 23.
PubMed 26496957Mafeld S, Annamalai G, Lindsay TF, Zhong I, Tarulli E, Mironov O, Tan KT. Initial Experience With Viabahn VBX as the Bridging Stent Graft for Branched and Fenestrated Endovascular Aneurysm Repair. Vasc Endovascular Surg. 2019 Jul;53(5):395-400. doi: 10.1177/1538574419840880. Epub 2019 Apr 24.
PubMed 31018828Spear R, Sobocinski J, Hertault A, Delloye M, Azzauiu R, Fabre D, Haulon S. One Year Outcomes of 101 BeGraft Stent Grafts used as Bridging Stents in Fenestrated Endovascular Repairs. Eur J Vasc Endovasc Surg. 2018 Apr;55(4):504-510. doi: 10.1016/j.ejvs.2018.01.023. Epub 2018 Mar 1.
PubMed 29501401Donas KP, Lee JT, Lachat M, Torsello G, Veith FJ; PERICLES investigators. Collected world experience about the performance of the snorkel/chimney endovascular technique in the treatment of complex aortic pathologies: the PERICLES registry. Ann Surg. 2015 Sep;262(3):546-53; discussion 552-3. doi: 10.1097/SLA.0000000000001405.
PubMed 26258324Timaran DE, Knowles M, Soto-Gonzalez M, Modrall JG, Tsai S, Kirkwood M, Rectenwald J, Timaran CH. Gender and perioperative outcomes after fenestrated endovascular repair using custom-made and off-the-shelf devices. J Vasc Surg. 2016 Aug;64(2):267-272. doi: 10.1016/j.jvs.2016.02.062. Epub 2016 Jun 15.
PubMed 27316411Verhoeven EL, Katsargyris A, Oikonomou K, Kouvelos G, Renner H, Ritter W. Fenestrated Endovascular Aortic Aneurysm Repair as a First Line Treatment Option to Treat Short Necked, Juxtarenal, and Suprarenal Aneurysms. Eur J Vasc Endovasc Surg. 2016 Jun;51(6):775-81. doi: 10.1016/j.ejvs.2015.12.014. Epub 2016 Feb 6.
PubMed 26860255Mastracci TM, Carrell T, Constantinou J, Dias N, Martin-Gonzalez T, Katsargyris A, Modarai B, Resch T, Verhoeven EL, Burnell M, Haulon S. Editor's Choice - Effect of Branch Stent Choice on Branch-related Outcomes in Complex Aortic Repair. Eur J Vasc Endovasc Surg. 2016 Apr;51(4):536-42. doi: 10.1016/j.ejvs.2015.12.046. Epub 2016 Feb 23.
PubMed 26916389Asciutto G, Ibrahim A, Leone N, Gennai S, Piazza M, Antonello M, Wanhainen A, Mani K, Lindstrom D, Struk L, Oberhuber A. Intravascular Ultrasound in the Detection of Bridging Stent Graft Instability During Fenestrated and Branched Endovascular Aneurysm Repair Procedures: A Multicentre Study on 274 Target Vessels. Eur J Vasc Endovasc Surg. 2024 Jan;67(1):99-104. doi: 10.1016/j.ejvs.2023.09.009. Epub 2023 Sep 12.
PubMed 37704100
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Register of Anatomical / Geometric Data Obtained by Intravascular Ultrasound (IVUS) Examinatio´n of Bridging Stent Grafts in Complex Aortic Interventions
- ClinicalTrials.gov ID
- NCT04663074
- Acronym / sponsor ID
- 01_2020
- Conditions
- Thoracic Aortic Aneurysm
- Keywords
- Intravascular ultrasound, bridging stentgraft, BEVAR, EVAR, IVUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 10 Dec 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.
The study aims to investigate the applicability of intravascular ultrasound (IVUS) in the endovascular therapy of juxta-, supra- and thoracoabdominal aortic aneurysms.
The focus of the study is on the intraoperative and postoperative evaluation of the geometric data of bridging stentgrafts in terms of patency, occurrence of stenosis and/or kinking.
Detailed description
Intravascular ultrasound (IVUS) is an already validated diagnostic method increasingly use in endovascular interventions. In contrast to conventional digital subtraction angiography (DSA), the IVUS provides in vivo real-time vessel images. Furthermore, its accuracy has been examined in histological studies, which could report of a good correlation regarding the vessel diameters (Jin ZG et al. Int J Cardiovasc Imaging. 2017 Feb; 33 (2): 153-160.).
Stenosis and/or kinkings of stents or stentgrafts as well as their fully expansion and morphology can be assessed with the use of IVUS.
The IVUS has already been used successfully in the context of endovascular treatment of infrarenal aortic aneurysms (Endovascular Aortic Repair or EVAR). Here, the IVUS has proven to be a valuable diagnostic instrument to examine the anatomy of the inserted stent grafts intraoperatively and to detect any abnormalities. In addition, the use of IVUS led to a significant reduction in the use of iodine-containing contrast media and radiation exposure as part of these complex endovascular interventions (Pecoraro F et al. Ann Vasc Surg. 2019 Apr; 56: 209-215.).
In the endovascular therapy of thoracoabdominal as well as suprarenal and juxtarenal aortic aneurysms, stent grafts with recesses (windows - Fenestrated EVAR or FEVAR) or side arms (branches - Branched EVAR or BEVAR) for the renovisceral vessels (truncus coeliacus, superior mesenteric artery and renal arteries) are implanted. In exceptional cases, the renovisceral vessels are supplied with stent grafts that are implanted in parallel to the aortic stent grafts (Chimney-Technique). These branches or windows are then connected to the corresponding target vessels via a bridging stent graft. The patency and anatomy of the bridging stent grafts are usually checked intraoperatively by angiography. The dynamics of the contrast agent flow and the X-ray images of the framework of the stent graft help in assessing their patency as well as the absence of structural problems.
The Computed Tomographic Angiography (CTA) is considered the gold standard as diagnostic method to assess the patency and anatomy of the stentgrafts postoperatively. This diagnostic method bares with it the exposure to relevant radiation dose as well as to contrast media. However, CTA scans do not provide in vivo real-time vessel images.
Furthermore, in case of pathological findings a new intervention may be necessary. The IVUS technique overcomes these issues due to its low invasiveness and its possible use during the index procedure. This can lead to the immediate identification of eventual structural problems of the bridging stent grafts which can jeopardize their patency and to correct them already during the index procedure.
The use of the IVUS during FEVAR, BEVAR and CHEVAR has already been implemented in our clinical routine. At our knowledge, a prospective collection of anatomical-geometric data by IVUS in complex endovascular treatments of complex aortic aneurysm has not been yet reported.
The aim of the current study is the retrospective evaluation of the anatomical-geometric data already collected by IVUS as well as the prospective collection of new data regarding the patency and anatomy of bridging stent grafts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVUS Group | – | Diagnostic Test: IVUS controlPatients treated by BEVAR/CHEVAR/FEVAR due to a thoracoabdominal aneurysm. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by BEVAR/CHEVAR/FEVAR due to a thoracoabdominal aneurysm,
Key inclusion criteria (3 listed)
- Age over 18 years
- Elective or emergency treatment of an aortic aneurysm with a branched or fenestrated stent graft or with the aid of parallel stent grafts´(chimney)
- Patient capable of giving informed consent
Key exclusion criteria (2 listed)
- Patients who are already participating in another study
- child bearing or breast feeding females
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 |
|---|---|---|
| IVUS controlAlso: Volcano PhilipsIntravascular Control of the bridging stentgrafts during branched EVAR | Diagnostic test | IVUS Group |
Primary outcome
bSG patency
Time frame: 5 years
Patency of the bridging stentgraft
1 secondary outcome
Geometrical changes
Time frame: 5 years
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 21 Sep 2023.
- Background: PubMed 27730313Jin ZG, Zhang ZQ, Jing LM, Wei YJ, Zhang J, Luo JP, Yang SL, Ma DX, Liu Y, Han W, Yang Y, Liu HL. Correlation between dual-axis rotational coronary angiography and intravascular ultrasound in a coronary lesion assessment. Int J Cardiovasc Imaging. 2017 Feb;33(2):153-160. doi: 10.1007/s10554-016-0999-5. Epub 2016 Oct 11.
- Background: PubMed 30500656Pecoraro F, Bracale UM, Farina A, Badalamenti G, Ferlito F, Lachat M, Dinoto E, Asti V, Bajardi G. Single-Center Experience and Preliminary Results of Intravascular Ultrasound in Endovascular Aneurysm Repair. Ann Vasc Surg. 2019 Apr;56:209-215. doi: 10.1016/j.avsg.2018.09.016. Epub 2018 Nov 27.
- Background: PubMed 26496957Georgiadis GS, van Herwaarden JA, Antoniou GA, Hazenberg CE, Giannoukas AD, Lazarides MK, Moll FL. Systematic Review of Off-the-Shelf or Physician-Modified Fenestrated and Branched Endografts. J Endovasc Ther. 2016 Feb;23(1):98-109. doi: 10.1177/1526602815611887. Epub 2015 Oct 23.
- Background: PubMed 31018828Mafeld S, Annamalai G, Lindsay TF, Zhong I, Tarulli E, Mironov O, Tan KT. Initial Experience With Viabahn VBX as the Bridging Stent Graft for Branched and Fenestrated Endovascular Aneurysm Repair. Vasc Endovascular Surg. 2019 Jul;53(5):395-400. doi: 10.1177/1538574419840880. Epub 2019 Apr 24.
- Background: PubMed 29501401Spear R, Sobocinski J, Hertault A, Delloye M, Azzauiu R, Fabre D, Haulon S. One Year Outcomes of 101 BeGraft Stent Grafts used as Bridging Stents in Fenestrated Endovascular Repairs. Eur J Vasc Endovasc Surg. 2018 Apr;55(4):504-510. doi: 10.1016/j.ejvs.2018.01.023. Epub 2018 Mar 1.
- Background: PubMed 26258324Donas KP, Lee JT, Lachat M, Torsello G, Veith FJ; PERICLES investigators. Collected world experience about the performance of the snorkel/chimney endovascular technique in the treatment of complex aortic pathologies: the PERICLES registry. Ann Surg. 2015 Sep;262(3):546-53; discussion 552-3. doi: 10.1097/SLA.0000000000001405.
- Background: PubMed 27316411Timaran DE, Knowles M, Soto-Gonzalez M, Modrall JG, Tsai S, Kirkwood M, Rectenwald J, Timaran CH. Gender and perioperative outcomes after fenestrated endovascular repair using custom-made and off-the-shelf devices. J Vasc Surg. 2016 Aug;64(2):267-272. doi: 10.1016/j.jvs.2016.02.062. Epub 2016 Jun 15.
- Background: PubMed 26860255Verhoeven EL, Katsargyris A, Oikonomou K, Kouvelos G, Renner H, Ritter W. Fenestrated Endovascular Aortic Aneurysm Repair as a First Line Treatment Option to Treat Short Necked, Juxtarenal, and Suprarenal Aneurysms. Eur J Vasc Endovasc Surg. 2016 Jun;51(6):775-81. doi: 10.1016/j.ejvs.2015.12.014. Epub 2016 Feb 6.
- Background: PubMed 26916389Mastracci TM, Carrell T, Constantinou J, Dias N, Martin-Gonzalez T, Katsargyris A, Modarai B, Resch T, Verhoeven EL, Burnell M, Haulon S. Editor's Choice - Effect of Branch Stent Choice on Branch-related Outcomes in Complex Aortic Repair. Eur J Vasc Endovasc Surg. 2016 Apr;51(4):536-42. doi: 10.1016/j.ejvs.2015.12.046. Epub 2016 Feb 23.
- Derived from this study: PubMed 37704100Asciutto G, Ibrahim A, Leone N, Gennai S, Piazza M, Antonello M, Wanhainen A, Mani K, Lindstrom D, Struk L, Oberhuber A. Intravascular Ultrasound in the Detection of Bridging Stent Graft Instability During Fenestrated and Branched Endovascular Aneurysm Repair Procedures: A Multicentre Study on 274 Target Vessels. Eur J Vasc Endovasc Surg. 2024 Jan;67(1):99-104. doi: 10.1016/j.ejvs.2023.09.009. Epub 2023 Sep 12.
- 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.
Alexander Oberhuber principal investigator
University Hospital Muenster
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Aneurysm, run by University Hospital Muenster at 6 sites in 4 countries.
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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Italy, Denmark, Sweden. 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?
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?
bSG patency (time frame: 5 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 NCT04663074, which also lists 10 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 21 Sep 2023.