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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05224219
Other study ID # MPSRA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 1, 2022

Study information

Verified date February 2022
Source University of Bologna
Contact Enrico Gallitto, MD, PhD
Phone +393330512143288
Email enrico.gallitto@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Advanced Endovascular repair of aneurysms and dissections involving thoraco-abdominal (type I-IV) and complex abdominal (juxta and para-renal) aorta is a ground-gaining procedure allowing favorable results in high surgical risk patients. The availability of iliac vessels navigation and the major role of lower leg perfusion in order to decrease the risk of spinal cord ischemia during these complex procedures, led to the development of devices with lower sheaths sizes and to the improvement of the technique with preloaded devices for visceral vessels in order to navigate in hostile anatomies or when an iliac access is not available. The aim of the study is to evaluate in a prospective single center observational setting, the outcomes, safety and efficacy of the modified preloaded system for renal arteries in fenestrated endografting in the routine treatment of paravisceral and thoraco-abdominal aortic pathologies.


Description:

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Study Design


Locations

Country Name City State
Italy University of Bologna Bologna Emilia Romagna

Sponsors (1)

Lead Sponsor Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Bertoglio L, Loschi D, Grandi A, Melloni A, Bilman V, Melissano G, Chiesa R. Early Limb Reperfusion Using Routinely Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures. Cardiovasc Intervent Radiol. 2020 Dec;43(12):1868-188 — View Citation

Gallitto E, Faggioli G, Spath P, Pini R, Mascoli C, Ancetti S, Stella A, Abualhin M, Gargiulo M. The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft. J Vasc Surg. 2020 Jul; — View Citation

Gallitto E, Gargiulo M, Faggioli G, Pini R, Mascoli C, Freyrie A, Ancetti S, Stella A. Impact of iliac artery anatomy on the outcome of fenestrated and branched endovascular aortic repair. J Vasc Surg. 2017 Dec;66(6):1659-1667. doi: 10.1016/j.jvs.2017.04. — View Citation

Maurel B, Resch T, Spear R, Roeder B, Bracale UM, Haulon S, Mastracci TM. Early experience with a modified preloaded system for fenestrated endovascular aortic repair. J Vasc Surg. 2017 Apr;65(4):972-980. doi: 10.1016/j.jvs.2016.09.045. — View Citation

Spanos K, Kölbel T, Kubitz JC, Wipper S, Konstantinou N, Heidemann F, Rohlffs F, Debus SE, Tsilimparis N. Risk of spinal cord ischemia after fenestrated or branched endovascular repair of complex aortic aneurysms. J Vasc Surg. 2019 Feb;69(2):357-366. doi: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Technical Success Successful deployment of custom-made modified endograft, target vessel patency and aneurysm exclusion, in absence of intra-operative mortality. Intra-operative final completion angiography.
Primary Mortality Assessment of mortality related to procedure Within the first 30-days from the procedure.
Secondary Cardiovascular Adverse Events Cardiopulmonary and renal events related to the procedure. Within the first 30-days from the procedure.
Secondary Neurologic Adverse Events Incidence of Spinal Cord Ischemia (transient/permanent) and Stroke Within the first 30-days from the procedure.
Secondary Vessel Instability Target vessel patency and absence of stenosis, endoleak, occlusion, need for reintervention Within the first 30-days from the procedure.
Secondary Rate of early reintervention Any re-intervention needed after the type of procedure and the specific reason Within the first 30-days from the procedure.
Secondary Overall Survival Assessment of mortality in the post-operative period Through study completion, an average of 1 year.
Secondary Aorta Related Survival Assessment of mortality in the post-operative period related to aortic procedure or aortic related death. Through study completion, an average of 1 year.
Secondary Freedom from reintervention Time from procedure to the first aortic related/procedure related reintervention Through study completion, an average of 1 year.
Secondary Freedom from Vessel Instability Target vessel patency and absence of stenosis, endoleak, occlusion, need for reintervention Through study completion, an average of 1 year.
Secondary Freedom from Major Endoleaks Time from procedure to the presence of high-flow endoleak (TypeI/III) and from endoleak that required reintervention Through study completion, an average of 1 year.
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