Abdominal Aortic AneurysmRESTHONENCT05609539
Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm
An observational study of Abdominal Aortic Aneurysm, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
The goal of this multicenter, observational cohort study is to evaluates the clinical effectiveness of a single-renal scallop custom-made stent-graft (TREO, Terumo Aortic, Sunrise, FL) to treat "hostile" AAA with mismatched renal arteries as actual standard of care in this Vascular Unit The main question it aims to… 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?
- Endovascular Aortic Repair (EVAR)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 28 Sep 2025
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients fit to plead and with a diagnosis of AAA > 50mm with a mismatched takeoff of tthe renal arteries. All the patients must be fit to ever with a standard endoggraft and must be able to carry out adhere the follow-up requested
Who may be able to join
- Patients affected by infrarenal AAA > 50mm
- Treated in election for non-symptomatic AAA
- Anatomy inside Treo (Terumo Aortic) instruction to use (IFU)
- Distance between renal arteries >10mm on aortic center-lumen-line
- Age > 18
- Patient fit to plead
Show all 10Show fewer
- Both sex
- Written informed consent
- Treated in the coordinator center or in one of the study's participating centers
- Minimum follow-up requested: 3-months, 12-18 months and 5-years CTA; clinical and DUS examination at 6- and 12- and 36-months after the intervention and yearly thereafter
Who cannot join
- Patients with aortic pathologies different from AAA (aortic ulcers, dissection, pseudo-aneurysm etc)
- Treated in urgent/emergent setting for symptomatic or ruptured AAA
- AAA < 50mm
- Outside TREO (Terumo Aortic) IFU
- With an inter-renal distance measured of the center-lumen-line <10mm
- Age <18
Show all 10Show fewer
- Unfit to plead
- Refused to sign the informed consent
- Treated outside the coordinator centers or in one of the study's participating center's
- Refusal to adhere to the requested follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm: Clinical Pivotal Trial
The goal of this multicenter, observational cohort study is to evaluates the clinical effectiveness of a single-renal scallop custom-made stent-graft (TREO, Terumo Aortic, Sunrise, FL) to treat "hostile" AAA with mismatched renal arteries as actual standard of care in this Vascular Unit The main question it aims to answer are: if a dedicated devices could improve the results in the endovascular treatment of patients suffering to infrarenal abdominal aortic aneurism with a mismatched takeoff of the renal arteries.
Participants responding to inclusion criteria will be treated as best clinical practice with a custom made device with a single scallop for the renal artery. The minimum follow-up requested, as standard clinical practice, was: 3-months, 12-18 months- and 5-years CTA; clinical and DUS examination at 6- and 12- and 36-months after the intervention and yearly thereafter.
No comparison group was present.
Read the detailed description
Endovascular aneurysm repair (EVAR) is currently the preferred choice to treat the abdominal aortic aneurysms (AAA) with a feasible anatomy. However, approximately 40-60% of AAA patients presented unfavorable characteristics for EVAR, mainly due to a "hostile neck anatomy". In ''real-world'' clinical practice, up to 44% of EVAR cases are performed outside Instruction For Use (IFU) for an adverse neck anatomy6. Short (<15-mm), angulated (>60°), and wide (>28-mm) aortic necks are the main features concurring to the proximal HNA.
The recourse to standard EVAR is currently routine for patients who are not eligible for OR, with acceptable short- and mid-term outcomes, but the long-term durability of EVAR depends on maintaining proper sealing between the endograft and the aortic neck as well as the iliac arteries. HNAs demonstrated worse results when compared to "favorable" ones in terms of technical success (94% vs. 98%) and type-Ia endoleak rate (10% vs. 2%). The issue linked to an unfavorable anatomy can be addressed with more complex techniques, but these are limited by high production costs and considerable complexity .
TREO (Terumo Aortic, Inchinnan, Renfrewshire, UK; formerly Treovance, Bolton Medical, Sunrise, Fla) is a standard bifurcated, modular stent-graft that has shown compelling early- and mid-term results. It seems clear that several physicians are still looking for a feasible solution for HNA patients to keep the complexity of the procedure comparable to standard EVAR while yielding improved results.
Moreover, there is a lack of publications addressing the issue of mismatched take-off of the renal arteries (RAs). This morphology seems to influence the sealing length and could justify the introduction of dedicated devices. A recent study from our group currently under review for publication demonstrated that 25% of patients eligible for EVAR presented with mismatched RAs and that a dedicated device could improve sealing significantly. The study group sealing zone's length increased by about 25% when applying a hypothetical prototype with a single 10x10mm (wide x high) renal scallop. The same approach could be applied to the sealing surface with similar results. In the light of obtained results in selected patients, the use of a "single renal-scallop" custom-made device has been our standard of care.
The results will demonstrate whether the supra mentioned graft can the treatment of AAA with mismatched RAs in the real world. The effectiveness will be evaluated in terms of technical and clinical success.
The benefits could be relevant for the patients in terms of reduction of procedure-related adverse events such as endoleaks and related re-interventions. Furthermore, the use of custom-made standardized devices could significantly reduce costs for health care providers and in the future, it could be the base for an "off-the-shelf" endograft. Procedure-related complications were expected to be similar to standard EVAR and reduced in comparison with literature reporting adverse events in more complex techniques.
The present study aims to evaluate the clinical effectiveness of the custom-made standardized single renal scalloped stent-graft (Treo, Terumo Aortic) to treat infrarenal AAA. The final objective will be to employ the data obtained in this cohort for a future eventual development of an "off-the-shelf" device dedicated to patients with mismatched renal arteries. Such an endograft could keep the complexity of the procedure as similar as possible to standard EVAR while improving sealing.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Endovascular Aortic Repair (EVAR)
- Keywords
- AAA, EVAR, Hostile Neck Anatomy
- 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.
Endovascular Aortic Repair (EVAR)Device
Techniques for delivery and deployment of the standard device have been well described by different papers, but for the "prototype" some attention is required.
Once the device was advanced at the level of the lowest RA the C-Arm has been moved to correct the parallax effect and positioned orthogonally to the origin of the artery. This procedure permits perfectly matching the scallop with the artery takeoff.
A selective angiogram was performed to assure the patency of the lower RA. After the deployment of the main body proper iliac extensions were delivered to completely exclude the aneurysm as standard practice.
| Study group | Role | What they receive |
|---|---|---|
| AAA patients with a mismatched takeoff of the renal arteries candidated to standard EVAR | Patients suffering to AAA with a mismatched takeoff (>10mm) of the renal arteries Receives: Device: Endovascular Aortic Repair (EVAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the clinical effectiveness of the endovascular exclusion of infrarenal Abdominal Aortic Aneurysm with a single renal scallop endograft
Clinical effectiveness measured in terms of technical and clinical success. Technical success was defined as successful introduction and deployment of the device in the absence of surgical conversion or mortality, type I or III endoleaks, or graft limb obstruction. A technical success thus implies the following qualifying details: 1. Successful access to the arterial system using a remote site; 2. successful deployment of the endoluminal graft with secure proximal and distal fixation; 3. absence of either a type I or III endoleak; 4. patent endoluminal graft without significant twist, kinks, or obstruction by intraoperative measurements; 5 patency of both renal arteries and at least one hypogastric artery.
Measured: up to 24 hours
Secondary outcomes (9)
Evaluation of the intra-operative and peri-operative (within 30 days) adverse events
Measured: up to 30 days
Collection of eventual adverse events related to the treatment procedure and eventual post-hoc analysis
Measured: "through study completion, an average of 2 years".
Evaluation of reintervention rate
Measured: "through study completion, an average of 2 years".
Evaluation time elapsed from procedure to re-intervention
Measured: "through study completion, an average of 2 years".
Evaluation of the association between baseline and anatomical features to adverse technical success, clinical success and reintervention rate
Measured: "through study completion, an average of 2 years".
Evaluation of the average procedural time
Measured: up to 24 hours
Evaluation of the average fluoroscopy time
Measured: up to 24 hours
Evaluation of the average contrast medium (CM)
Measured: up to 24 hours
Evaluation of the average dose absorption (DAP) mGy/m3
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Feb 2023
- Primary completion28 Sep 2025
- Study completion28 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale di Circolo - Fondazione Macchi, Azienda Ospedaliera di Padova, Azienda Ospedaliera Ordine Mauriziano di Torino, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Principal investigator, Roberto Silingardi, MD, Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Roberto Silingardi, Prof., Study chair, AOU di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609539
- Sponsor's protocol ID
- RESTHONE
- Acronym
- RESTHONE
- Status last verified
- Sep 2025
- First submitted
- 31 Oct 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Marone EM, Freyrie A, Ruotolo C, Michelagnoli S, Antonello M, Speziale F, Veroux P, Gargiulo M, Gaggiano A. Expert Opinion on Hostile Neck Definition in Endovascular Treatment of Abdominal Aortic Aneurysms (a Delphi Consensus). Ann Vasc Surg. 2020 Jan;62:173-182. doi: 10.1016/j.avsg.2019.05.049. Epub 2019 Aug 6.
PubMed 31394211Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. 2018 Jun;67(6):1699-1707. doi: 10.1016/j.jvs.2017.10.059. Epub 2017 Dec 18.
PubMed 29248241Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available.
PubMed 30528142Chaikof 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 29268916Speziale F, Sirignano P, Setacci F, Menna D, Capoccia L, Mansour W, Galzerano G, Setacci C. Immediate and two-year outcomes after EVAR in "on-label" and "off-label" neck anatomies using different commercially available devices. analysis of the experience of two Italian vascular centers. Ann Vasc Surg. 2014 Nov;28(8):1892-900. doi: 10.1016/j.avsg.2014.06.057. Epub 2014 Jul 7.
PubMed 25011083Stather PW, Wild JB, Sayers RD, Bown MJ, Choke E. Endovascular aortic aneurysm repair in patients with hostile neck anatomy. J Endovasc Ther. 2013 Oct;20(5):623-37. doi: 10.1583/13-4320MR.1.
PubMed 24093314AbuRahma AF, DerDerian T, AbuRahma ZT, Hass SM, Yacoub M, Dean LS, Abu-Halimah S, Mousa AY. Comparative study of clinical outcome of endovascular aortic aneurysms repair in large diameter aortic necks (>31 mm) versus smaller necks. J Vasc Surg. 2018 Nov;68(5):1345-1353.e1. doi: 10.1016/j.jvs.2018.02.037. Epub 2018 May 22.
PubMed 29802043Antoniou GA, Antoniou SA, Torella F. Editor's Choice - Endovascular vs. Open Repair for Abdominal Aortic Aneurysm: Systematic Review and Meta-analysis of Updated Peri-operative and Long Term Data of Randomised Controlled Trials. Eur J Vasc Endovasc Surg. 2020 Mar;59(3):385-397. doi: 10.1016/j.ejvs.2019.11.030. Epub 2019 Dec 30.
PubMed 31899100Sveinsson M, Sonesson B, Kristmundsson T, Dias N, Resch T. Long-term outcomes after fenestrated endovascular aortic repair for juxtarenal aortic aneurysms. J Vasc Surg. 2022 Apr;75(4):1164-1170. doi: 10.1016/j.jvs.2021.11.050. Epub 2021 Nov 25.
PubMed 34838610Eagleton MJ, Stoner M, Henretta J, Dryjski M, Panneton J, Tassiopoulos A, Mehta M, Pearce B, Sharafuddin MJ; TREO Investigators. Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms. J Vasc Surg. 2021 Jul;74(1):114-123.e3. doi: 10.1016/j.jvs.2020.10.083. Epub 2020 Nov 28.
PubMed 33253871D'Oria M, Galeazzi E, Veraldi GF, Garriboli L, Sacca S, Farneti F, Mezzetto L, Mastrorilli D, Lepidi S; ITA-ENDOBOOT registry collaborators.. Impact of Proximal Neck Anatomy on Short-Term and Mid-Term Outcomes After Treatment of Abdominal Aortic Aneurysms With New-Generation Low-Profile Endografts. Results From the Multicentric "ITAlian North-East Registry of ENDOvascular Aortic Repair With the BOltOn Treo Endograft (ITA-ENDOBOOT)". Ann Vasc Surg. 2022 Mar;80:37-49. doi: 10.1016/j.avsg.2021.08.059. Epub 2021 Nov 6.
PubMed 34752851Murray D, Szeberin Z, Benevento D, Abdallah F, Palasciano G, Lescan M, Uberoi R, Setacci C. A comparison of clinical outcomes of abdominal aortic aneurysm patients with favorable and hostile neck angulation treated by endovascular repair with the Treovance stent graft. J Vasc Surg. 2020 Jun;71(6):1881-1889. doi: 10.1016/j.jvs.2019.07.096. Epub 2019 Nov 2.
PubMed 31690524Oderich GS, Farber MA, Schneider D, Makaroun M, Sanchez LA, Schanzer A, Beck AW, Starnes BW, Fillinger M, Tenorio ER, Chen M, Zhou Q; Zenith Fenestrated Study Investigators. Final 5-year results of the United States Zenith Fenestrated prospective multicenter study for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2021 Apr;73(4):1128-1138.e2. doi: 10.1016/j.jvs.2020.08.128. Epub 2020 Sep 3.
PubMed 32891806Gallitto E, Gargiulo M, Freyrie A, Mascoli C, Massoni Bianchini C, Ancetti S, Faggioli G, Stella A. The endovascular treatment of juxta-renal abdominal aortic aneurysm using fenestrated endograft: early and mid-term results. J Cardiovasc Surg (Torino). 2019 Apr;60(2):237-244. doi: 10.23736/S0021-9509.16.09049-2. Epub 2015 Sep 29.
PubMed 26417936Locham S, Faateh M, Dhaliwal J, Nejim B, Dakour-Aridi H, Malas MB. Outcomes and cost of fenestrated versus standard endovascular repair of intact abdominal aortic aneurysm in the United States. J Vasc Surg. 2019 Apr;69(4):1036-1044.e1. doi: 10.1016/j.jvs.2018.06.211. Epub 2018 Oct 3.
PubMed 30292604
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm: Clinical Pivotal Trial
- ClinicalTrials.gov ID
- NCT05609539
- Acronym / sponsor ID
- RESTHONE / RESTHONE
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- AAA, EVAR, Hostile Neck Anatomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Collaborators
- Ospedale di Circolo - Fondazione Macchi, Azienda Ospedaliera di Padova, Azienda Ospedaliera Ordine Mauriziano di Torino, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Sep 2025 (actual)
- Study completion
- 28 Sep 2025 (actual)
- First posted
- 8 Nov 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 goal of this multicenter, observational cohort study is to evaluates the clinical effectiveness of a single-renal scallop custom-made stent-graft (TREO, Terumo Aortic, Sunrise, FL) to treat "hostile" AAA with mismatched renal arteries as actual standard of care in this Vascular Unit The main question it aims to answer are: if a dedicated devices could improve the results in the endovascular treatment of patients suffering to infrarenal abdominal aortic aneurism with a mismatched takeoff of the renal arteries.
Participants responding to inclusion criteria will be treated as best clinical practice with a custom made device with a single scallop for the renal artery. The minimum follow-up requested, as standard clinical practice, was: 3-months, 12-18 months- and 5-years CTA; clinical and DUS examination at 6- and 12- and 36-months after the intervention and yearly thereafter.
No comparison group was present.
Detailed description
Endovascular aneurysm repair (EVAR) is currently the preferred choice to treat the abdominal aortic aneurysms (AAA) with a feasible anatomy. However, approximately 40-60% of AAA patients presented unfavorable characteristics for EVAR, mainly due to a "hostile neck anatomy". In ''real-world'' clinical practice, up to 44% of EVAR cases are performed outside Instruction For Use (IFU) for an adverse neck anatomy6. Short (<15-mm), angulated (>60°), and wide (>28-mm) aortic necks are the main features concurring to the proximal HNA.
The recourse to standard EVAR is currently routine for patients who are not eligible for OR, with acceptable short- and mid-term outcomes, but the long-term durability of EVAR depends on maintaining proper sealing between the endograft and the aortic neck as well as the iliac arteries. HNAs demonstrated worse results when compared to "favorable" ones in terms of technical success (94% vs. 98%) and type-Ia endoleak rate (10% vs. 2%). The issue linked to an unfavorable anatomy can be addressed with more complex techniques, but these are limited by high production costs and considerable complexity .
TREO (Terumo Aortic, Inchinnan, Renfrewshire, UK; formerly Treovance, Bolton Medical, Sunrise, Fla) is a standard bifurcated, modular stent-graft that has shown compelling early- and mid-term results. It seems clear that several physicians are still looking for a feasible solution for HNA patients to keep the complexity of the procedure comparable to standard EVAR while yielding improved results.
Moreover, there is a lack of publications addressing the issue of mismatched take-off of the renal arteries (RAs). This morphology seems to influence the sealing length and could justify the introduction of dedicated devices. A recent study from our group currently under review for publication demonstrated that 25% of patients eligible for EVAR presented with mismatched RAs and that a dedicated device could improve sealing significantly. The study group sealing zone's length increased by about 25% when applying a hypothetical prototype with a single 10x10mm (wide x high) renal scallop. The same approach could be applied to the sealing surface with similar results. In the light of obtained results in selected patients, the use of a "single renal-scallop" custom-made device has been our standard of care.
The results will demonstrate whether the supra mentioned graft can the treatment of AAA with mismatched RAs in the real world. The effectiveness will be evaluated in terms of technical and clinical success.
The benefits could be relevant for the patients in terms of reduction of procedure-related adverse events such as endoleaks and related re-interventions. Furthermore, the use of custom-made standardized devices could significantly reduce costs for health care providers and in the future, it could be the base for an "off-the-shelf" endograft. Procedure-related complications were expected to be similar to standard EVAR and reduced in comparison with literature reporting adverse events in more complex techniques.
The present study aims to evaluate the clinical effectiveness of the custom-made standardized single renal scalloped stent-graft (Treo, Terumo Aortic) to treat infrarenal AAA. The final objective will be to employ the data obtained in this cohort for a future eventual development of an "off-the-shelf" device dedicated to patients with mismatched renal arteries. Such an endograft could keep the complexity of the procedure as similar as possible to standard EVAR while improving sealing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA patients with a mismatched takeoff of the renal arteries candidated to standard EVAR | – | Device: Endovascular Aortic Repair (EVAR)Patients suffering to AAA with a mismatched takeoff (>10mm) of the renal arteries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients fit to plead and with a diagnosis of AAA > 50mm with a mismatched takeoff of tthe renal arteries. All the patients must be fit to ever with a standard endoggraft and must be able to carry out adhere the follow-up requested
Key inclusion criteria (10 listed)
- Patients affected by infrarenal AAA > 50mm
- Treated in election for non-symptomatic AAA
- Anatomy inside Treo (Terumo Aortic) instruction to use (IFU)
- Distance between renal arteries >10mm on aortic center-lumen-line
- Age > 18
Key exclusion criteria (10 listed)
- Patients with aortic pathologies different from AAA (aortic ulcers, dissection, pseudo-aneurysm etc)
- Treated in urgent/emergent setting for symptomatic or ruptured AAA
- AAA < 50mm
- Outside TREO (Terumo Aortic) IFU
- With an inter-renal distance measured of the center-lumen-line <10mm
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 Aortic Repair (EVAR)Techniques for delivery and deployment of the standard device have been well described by different papers, but for the "prototype" some attention is required. Once the device was advanced at the level of the lowest RA the C-Arm has been moved to correct the parallax effect and positioned orthogonally to the origin of the artery. This procedure permits perfectly matching the scallop with the artery takeoff. A selective angiogram was performed to assure the patency of the lower RA. After the deployment of the main body proper iliac extensions were delivered to completely exclude the aneurysm as standard practice. | Device | AAA patients with a mismatched takeoff of the renal arteries candidated to standard EVAR |
Primary outcome
Evaluation of the clinical effectiveness of the endovascular exclusion of infrarenal Abdominal Aortic Aneurysm with a single renal scallop endograft
Time frame: up to 24 hours
Clinical effectiveness measured in terms of technical and clinical success. Technical success was defined as successful introduction and deployment of the device in the absence of surgical conversion or mortality, type I or III endoleaks, or graft limb obstruction. A technical success thus implies the following qualifying details: 1. Successful access to the arterial system using a remote site; 2. successful deployment of the endoluminal graft with secure proximal and distal fixation; 3. absence of either a type I or III endoleak; 4. patent endoluminal graft without significant twist, kinks, or obstruction by intraoperative measurements; 5 patency of both renal arteries and at least one hypogastric artery.
9 secondary outcomes
Evaluation of the intra-operative and peri-operative (within 30 days) adverse events
Time frame: up to 30 days
Collection of eventual adverse events related to the treatment procedure and eventual post-hoc analysis
Time frame: "through study completion, an average of 2 years".
Evaluation of reintervention rate
Time frame: "through study completion, an average of 2 years".
Evaluation time elapsed from procedure to re-intervention
Time frame: "through study completion, an average of 2 years".
Evaluation of the association between baseline and anatomical features to adverse technical success, clinical success and reintervention rate
Time frame: "through study completion, an average of 2 years".
Evaluation of the average procedural time
Time frame: up to 24 hours
Evaluation of the average fluoroscopy time
Time frame: up to 24 hours
Evaluation of the average contrast medium (CM)
Time frame: up to 24 hours
Evaluation of the average dose absorption (DAP) mGy/m3
Time frame: up to 24 hours
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 2 Oct 2025.
- Background: PubMed 31394211Marone EM, Freyrie A, Ruotolo C, Michelagnoli S, Antonello M, Speziale F, Veroux P, Gargiulo M, Gaggiano A. Expert Opinion on Hostile Neck Definition in Endovascular Treatment of Abdominal Aortic Aneurysms (a Delphi Consensus). Ann Vasc Surg. 2020 Jan;62:173-182. doi: 10.1016/j.avsg.2019.05.049. Epub 2019 Aug 6.
- Background: PubMed 29248241Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. 2018 Jun;67(6):1699-1707. doi: 10.1016/j.jvs.2017.10.059. Epub 2017 Dec 18.
- Background: PubMed 30528142Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available.
- Background: 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.
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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.
Roberto Silingardi, Prof. study chair
AOU di Modena
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 Abdominal Aortic Aneurysm, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 10 inclusion and 10 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 2 Oct 2025. 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 Italy. 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?
Evaluation of the clinical effectiveness of the endovascular exclusion of infrarenal Abdominal Aortic Aneurysm with a single renal scallop endograft (time frame: up to 24 hours). 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 NCT05609539, which also lists 15 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 2 Oct 2025.