Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm

NCT05609539 | Completed DMC FDA Device

• 1 other identifier: RESTHONE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Abdominal Aortic Aneurysm

Keywords

AAA; EVAR; Hostile Neck Anatomy

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 hours

Secondary Outcomes (9)

• Evaluation of the intra-operative and peri-operative (within 30 days) adverse events

  up to 30 days

• Collection of eventual adverse events related to the treatment procedure and eventual post-hoc analysis

  "through study completion, an average of 2 years".

• Evaluation of reintervention rate

  "through study completion, an average of 2 years".

• Evaluation time elapsed from procedure to re-intervention

  "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

  "through study completion, an average of 2 years".

Study Arms (1)

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

Device: Endovascular Aortic Repair (EVAR)

Interventions

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.

AAA patients with a mismatched takeoff of the renal arteries candidated to standard EVAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead
• Ospedale di Circolo - Fondazione Macchi: collaborator
• Azienda Ospedaliera di Padova: collaborator
• Azienda Ospedaliera Ordine Mauriziano di Torino: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

AOU di Modena

Baggiovara, Modena, 41126, Italy

Location

Related Publications (15)

• 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.

  PMID: 31394211 BACKGROUND

• Muhs 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.

  PMID: 29248241 BACKGROUND

• Wanhainen 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.

  PMID: 30528142 BACKGROUND

• Chaikof 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.

  PMID: 29268916 BACKGROUND

• Speziale 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.

  PMID: 25011083 BACKGROUND

• Stather 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.

  PMID: 24093314 BACKGROUND

• AbuRahma 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.

  PMID: 29802043 BACKGROUND

• Antoniou 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.

  PMID: 31899100 BACKGROUND

• Sveinsson 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.

  PMID: 34838610 BACKGROUND

• Eagleton 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.

  PMID: 33253871 BACKGROUND

• D'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.

  PMID: 34752851 BACKGROUND

• Murray 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.

  PMID: 31690524 BACKGROUND

• Oderich 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.

  PMID: 32891806 BACKGROUND

• Gallitto 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.

  PMID: 26417936 BACKGROUND

• Locham 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.

  PMID: 30292604 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Roberto Silingardi, Prof.

  AOU di Modena

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 8, 2022
• Study Start: February 1, 2023
• Primary Completion: September 28, 2025
• Study Completion: September 28, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

IT (1)