Clinical trial NCT05609539: Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm
Official title: Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm: Clinical Pivotal Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Aortic Aneurysm
Keywords: AAA
EVAR
Hostile Neck Anatomy
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
Collaborators: name: Ospedale di Circolo - Fondazione Macchi
name: Azienda Ospedaliera di Padova
name: Azienda Ospedaliera Ordine Mauriziano di Torino
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2022-11-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of the clinical effectiveness of the endovascular exclusion of infrarenal Abdominal Aortic Aneurysm with a single renal scallop endograft
timeFrame: up to 24 hours
Secondary outcomes:
measure: Evaluation of the intra-operative and peri-operative (within 30 days) adverse events
timeFrame: up to 30 days
measure: Collection of eventual adverse events related to the treatment procedure and eventual post-hoc analysis
timeFrame: "through study completion, an average of 2 years".
measure: Evaluation of reintervention rate
timeFrame: "through study completion, an average of 2 years".
measure: Evaluation time elapsed from procedure to re-intervention
timeFrame: "through study completion, an average of 2 years".
measure: Evaluation of the association between baseline and anatomical features to adverse technical success, clinical success and reintervention rate
timeFrame: "through study completion, an average of 2 years".
measure: Evaluation of the average procedural time
timeFrame: up to 24 hours
measure: Evaluation of the average fluoroscopy time
timeFrame: up to 24 hours
measure: Evaluation of the average contrast medium (CM)
timeFrame: up to 24 hours
measure: Evaluation of the average dose absorption (DAP) mGy/m3
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Baggiovara
country: Italy
facility: AOU di Modena
state: Modena
Study officials:
affiliation: AOU di Modena
name: Roberto Silingardi, Prof.
role: STUDY_CHAIR
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