Active clinical trials for "Aneurysm"

This is a multicenter, observational, prospective, single arm registry using Ovation Alto Endograft. A minimum of 50 up to a maximum of 120 subjects undergoing endovascular repair with Ovation Alto endograft will be enrolled and followed procedurally to discharge, at 1month, 6 months, 1 year and yearly afterward up to 3 years. This registry of Ovation Alto endograft will provide further assessment to confirm continuing safety and effectiveness of the graft and to confirm the stability of the neck diameter over time when treated with this device.

The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.

To analyse the clinical safety and efficacy of the DERIVO® 2heal® Embolisation Device in the standard clinical routine of flow diversion treatment with respect to the mid- and long-term clinical and angiographic outcomes.

A multi-center, prospective, single-arm, non-randomized, post-market, observational study. The primary objective of this study is to evaluate the long-term safety and efficacy of the Surpass Streamline Flow Diverter System (FDS) in the treatment of unruptured large and giant (≥ 10 mm) saccular wide-neck (neck width ≥ 4 mm) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm to ≤ 5.3 mm.

This is a pilot, prospective, randomized control trial that aim to provide a first estimation of the 3-month post-operative variation in the functional recovery of patients who benefited from an outpatient pre-habilitation program and patients who did not benefit from it.

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).

Since the 2000s, endovascular procedures have been expanding rapidly in multiple disciplines: cardiology, radiology, interventional neuroradiology, and of course vascular surgery. Most procedures are performed by puncture of the common femoral artery with introducers ranging in size from 4F to 26F for aortic procedures. The most frequent complications of percutaneous punctures are false femoral aneurysms due to failure to close the arterial gap (up to 8% in some studies). A false aneurysm is a pocket of blood communicating with an artery and secondary to the rupture of the arterial wall. The blood is then contained by the adjacent structures and often a fibrous shell which distinguishes it from an aneurysm which retains the integrity of its wall. The management of false femoral aneurysms is variable. Below 2 cm, monitoring may be performed with or without manual or ultrasound-guided compression. In case of persistence of the false aneurysm and/or complication, open surgery can be performed. Endovascular treatment of false aneurysms was first proposed in 1986. Different endovascular techniques can be proposed to occlude false aneurysms such as the use of coils, biological glue, the use of arterial closure systems... Echoguided injection of thrombin to occlude the false aneurysm in a manner has been published since the late 1990s. The treatment is evaluated as reliable and safe. A recent article in the EJVES (6) investigates the value of low-dose thrombin for this indication, and the results appear to be very encouraging for low-dose thrombin in false femoral aneurysms. Thrombin injection for the treatment of iatrogenic false femoral aneurysms is the technique currently favoured by the vascular surgery team at the Paris Saint Joseph Hospital Group (GHPSJ). Open surgery is a second-line treatment and remains indicated in case of acute symptoms (radiculalgia, motor/sensory deficits; ischemia, skin necrosis), a false aneurysm that is too deep or without a neck, an infectious origin or a patient treated with dabigatran. Patients will be reviewed at 1 and 12 months according to the usual follow-up. In this work, investigators will study the efficacy of false aneurysm closure using human thrombin injection. This work is intended to confirm previous work. A socio-economic study may be conducted in parallel. Follow-up after the use of percutaneous closure systems and in the context of bypass surgery may also be of interest.

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.

To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.