Aorto-iliac Occlusion Treatment With ShorT Unibody aorTic Endograft - ASTUTE Study

NCT05614856 | Suspended DMC FDA Device

• 1 other identifier: ASTUTE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this multi center prospective observational study is to evaluate the iliac patency rate during the time in patients treated with "AFX (Endologix, Irvine Calif)" unibody stent-graft for aorto-iliac occlusive disease The main question it aims to answer is if The Unibody AFX (Endologix) endograft could be in a large and real-world cohort of patients effective solution for the less-invasive treatment of the aortoiliac occlusive disease (AIOD). Participants affected by AIOD with an indication of endovascular treatment will be prospectively enrolled and treated as our clinical practice. The requested follow-up did not differ from the one suggested by the most recent guidelines

Conditions

Occlusive Arterial Disease

Keywords

EVAR; AIOD; Unibody endograft

Outcome Measures

Primary Outcomes (1)

• Patency rate

  short-, mid- and long-term patency rate (primary, assisted and secondary). Primary patency was defined as uninterrupted flow in the treated aortoiliac segment without occlusion or reintervention. Primary-assisted patency was defined as uninterrupted flow in the treated segment, allowing for reintervention for hemodynamically significant lesions in order to prevent occlusion. Secondary patency was defined as patency of the treated allowing for reintervention for occlusion.

  through study completion, an average of 30 days (short), 1-year (mid) and 5-years (long)".

Secondary Outcomes (7)

• Technical success

  within 24 hours of procedure conclusion

• Clinical Success

  through study completion, an average of 30 days (short), 1-year (mid) and 5-years (long)".

• Freedom from procedure related re-intervention and Adverse events

  through study completion, an average 2-years.

• Quality of life change

  through study completion, an average 2-years.

• Rutherford scale change

  through study completion, an average 2-years.

Study Arms (1)

Treatment Group

Patients affected by AIOD classified as TASC B, C or D involving aortic bifurcation and or the first 5mm of one of both common iliacs treated with the unibody endograft AFX (Endologix, Irvine, Calif)

Device: EVAR off-label use

Interventions

EVAR off-label use DEVICE

Normally a femoral access was used, although a brachial approach can be useful for crossing total occlusions. For TASC B and C lesions, predilatation of the iliac lesions is advisable, while for TASC D it is mandatory. In case of total aortic occlusions, the procedure demands that recanalization of the distal aorta occurs as close as possible to the bifurcation.. The key technique is to recanalize from one common iliac artery into the opposing snaring the wire to create a femoral-femoral crossover. The femoral-femoral wire is then replaced with a MPA catheter; the SurePass wire attached to the contralateral limb is then passed through the catheter. The sheath can be placed within 5 cm of the aortic bifurcation, and the AFX can be delivered through the common iliac and aortic occlusion. Predilatation were performed with bilateral 6-8 mm x 150 mm balloons and or progressive dilatators.

Also known as: Aorto-iliac recanalization with an abdominal aortic endograft

Treatment Group

Eligibility Criteria

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

Study Population

Patients affected by AIOD classified as TASC B, C or D involving aortic bifurcation and or the first 5mm of one of both common iliacs with indication to endovascular treatment enrolled at the Unit of Vascular Surgery of the Ospedale Civile di Baggiovara (Azienda Ospedaliero-Universitaria di Modena) and fulfilling the previous inclusion criteria. The Investigators (3 experts Vascular surgeons) will screen the patients for inclusion. Once the patient's eligibility will be stated, informed consent will be collected and the study could take place.

You may qualify if:

• Age \>18;
• Both sex;
• Preoperative 2.5mm CTA available;
• Written informed consent;
• Patients affected by AIOD classified as TASC B (with aortic involvement) C or D involving aortic bifurcation and or the first 5mm of one of both common iliacs;
• Treated in the coordinator center or in one of the study's participating center's;
• With a calcium volume in target zone based on real lumen of less than 20% and absence of circumferential calcifications;
• 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:

• Age\<18;
• No preoperative 2.5mm CTA available;
• Refused to sign the informed consent;
• Treated outside the coordinator centers or in one of the study's participating centers;
• Refusal to adhere to the requested follow-up;
• Patients affected by AIOD classified as TASC A or not involving aortic bifurcation or the first 5mm of one of both common iliacs;
• With a calcium volume in target zone based on real lumen of more than 20% and presence of circumferential calcifications;

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead
• Careggi Hospital: collaborator
• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: collaborator
• Azienda Policlinico Umberto I: collaborator
• S. Andrea Hospital: collaborator
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator
• Ospedale Policlinico San Martino: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• Azienda Ospedaliera Sant'Anna: collaborator

Study Sites (1)

AOU di Modena

Baggiovara, Modena, 41126, Italy

Location

Related Publications (19)

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• Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.

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• Grimme FA, Goverde PA, Van Oostayen JA, Zeebregts CJ, Reijnen MM. Covered stents for aortoiliac reconstruction of chronic occlusive lesions. J Cardiovasc Surg (Torino). 2012 Jun;53(3):279-89.

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• Sharafuddin MJ, Hoballah JJ, Kresowik TF, Sharp WJ, Golzarian J, Sun S, Corson JD. Long-term outcome following stent reconstruction of the aortic bifurcation and the role of geometric determinants. Ann Vasc Surg. 2008 May-Jun;22(3):346-57. doi: 10.1016/j.avsg.2007.12.013. Epub 2008 Apr 14.

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• Sabri SS, Choudhri A, Orgera G, Arslan B, Turba UC, Harthun NL, Hagspiel KD, Matsumoto AH, Angle JF. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. J Vasc Interv Radiol. 2010 Jul;21(7):995-1003. doi: 10.1016/j.jvir.2010.02.032. Epub 2010 Jun 11.

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• Mwipatayi BP, Thomas S, Wong J, Temple SE, Vijayan V, Jackson M, Burrows SA; Covered Versus Balloon Expandable Stent Trial (COBEST) Co-investigators. A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. J Vasc Surg. 2011 Dec;54(6):1561-70. doi: 10.1016/j.jvs.2011.06.097. Epub 2011 Sep 9.

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• Saratzis A, Salem M, Sabbagh C, Abisi S, Huasen B, Egun A, Nash J, Lau PF, Chaudhuri A, Dey R, Patrone L, Malina M, Davies R, Zayed H. Treatment of Aortoiliac Occlusive Disease With the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique: Results of a UK Multicenter Study. J Endovasc Ther. 2021 Oct;28(5):737-745. doi: 10.1177/15266028211025028. Epub 2021 Jun 23.

  PMID: 34160321 BACKGROUND

• Goverde PC, Grimme FA, Verbruggen PJ, Reijnen MM. Covered endovascular reconstruction of aortic bifurcation (CERAB) technique: a new approach in treating extensive aortoiliac occlusive disease. J Cardiovasc Surg (Torino). 2013 Jun;54(3):383-7.

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• Reijnen MM. Update on covered endovascular reconstruction of the aortic bifurcation. Vascular. 2020 Jun;28(3):225-232. doi: 10.1177/1708538119896197. Epub 2020 Jan 2.

  PMID: 31896301 BACKGROUND

• Sirignano P, Silingardi R, Mansour W, Andreoli F, Migliari M, Speziale F. Unibody bifurcated aortic endograft: device description, review of the literature and future perspectives. Future Cardiol. 2021 Aug;17(5):793-804. doi: 10.2217/fca-2020-0119. Epub 2020 Nov 23.

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• Silingardi R, Sirignano P, Andreoli F, Mansour W, Migliari M, Speziale F; LIVE Study Collaborators. Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study. JMIR Res Protoc. 2020 Apr 6;9(4):e16959. doi: 10.2196/16959.

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• Kouvelos GN, Nana P, Bouris V, Peroulis M, Drakou A, Rousas N, Giannoukas A, Matsagkas MI. Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study. Vasc Specialist Int. 2017 Mar;33(1):16-21. doi: 10.5758/vsi.2017.33.1.16. Epub 2017 Mar 31.

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MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Vascular Surgery, Chief of department

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 14, 2022
• Study Start: February 10, 2023
• Primary Completion: March 1, 2024
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

IT (1)