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Endoleak clinical trials

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NCT ID: NCT06456125 Active, not recruiting - Hemorrhage Clinical Trials

Safety and Efficacy Of Amber Peripheral Liquid Embolic System

OPAL
Start date: June 12, 2024
Phase: N/A
Study type: Interventional

A prospective, single-arm, multicenter, open-label, First-in-Human & Pivotal Study to assess the safety and efficacy of amber SEL-P in 70 patients requiring peripheral embolization: vascular anomalies, hemorrhages, aneurysms, and pseudoaneurysms, varicose veins, portal vein, hypervascular tumors, type -II endoleaks, and pathological organs. The study will be divided into two consecutive stages. Stage I will be dedicated to testing the device's safety, followed immediately by stage II, aimed to test the device's efficacy. The overall study sample will be used to assess the device safety and efficacy in all the enrolled participants.

NCT ID: NCT06374355 Not yet recruiting - Aortic Aneurysm Clinical Trials

Semibranch Registry - Retrospective

Start date: May 2024
Phase:
Study type: Observational

The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair.

NCT ID: NCT06318780 Recruiting - Aortic Diseases Clinical Trials

Concordance of Three Imaging Methods by Dynamic CT, Contrast Ultrasound and CT Angiography in the Characterization of Endoleaks in Patients With an Aortic Endoprosthesis

LEAKDYN
Start date: February 28, 2024
Phase: N/A
Study type: Interventional

Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Currently, three-phase CT angiography and CEUS ultrasound are recommended in the post-operative monitoring of EVAR but these remain limited in characterizing the type and source of endoleak. In this study the investigators will study the interest of d-CTA for a better detection and characterization of endoleaks.

NCT ID: NCT06187051 Completed - Aorta Aneurysm Clinical Trials

Type 1 Endoleak : Fenestrated Custom Made Endograft (FEVAR) Versus Open Surgery Explantation (OSR) : What's the Best

Start date: January 1, 2010
Phase:
Study type: Observational

Proximal type 1A endoleak is a worrying complication after endovascular repair of an abdominal aortic aneurysm (EVAR). The ideal solution is not obvious between relining by FEVAR and endograft explantation. A retrospective french multicentric study was performed between 2010 and 2023 to compare the outcomes and the efficiency of both technics and propose a decision algorithm for the management of type 1A endoleak after EVAR.

NCT ID: NCT06099015 Not yet recruiting - Portal Hypertension Clinical Trials

Cera™ Vascular Plug System Post-Market Clinical Follow-Up

Start date: June 2024
Phase:
Study type: Observational

The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: - confirm the performance - confirm the safety - identify previously unknown side-effects - monitor the identified side-effects (related to the procedures or to the medical devices) - identify and analyse emergent risks

NCT ID: NCT06059053 Recruiting - Aortic Aneurysm Clinical Trials

Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.

Start date: January 12, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair.

NCT ID: NCT05665101 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)

EVAR-SE
Start date: January 15, 2023
Phase: N/A
Study type: Interventional

Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture. Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.

NCT ID: NCT05309707 Recruiting - Clinical trials for Cardiovascular Diseases

ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0. The secondary objective is to evaluate the safety and clinical performance of the studied devices.

NCT ID: NCT05224219 Recruiting - Clinical trials for Thoracoabdominal Aortic Aneurysm

Modified Preloaded System for Renal Arteries in Fenestrated Endografting (MPSRA)

MPSRA
Start date: January 1, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT04751578 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands

AAA-SHAPE_NLD
Start date: July 13, 2021
Phase: N/A
Study type: Interventional

To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.