The ARIA trial protocol: a randomised controlled trial to assess the clinical, technical, and cost-effectiveness of a cloud-based, ARtificially Intelligent image fusion system in comparison to standard treatment to guide endovascular Aortic aneurysm repair
This study aims to assess the benefit to patients, practitioners, and the health service of a novel image fusion medical device (Cydar EV), which allows this high-resolution 3D information to be available to operators at the time of surgery.MethodsThe trial is a multi-centre, open label, two-armed randomised controlled clinical trial of 340 patient, randomised 1:1 to either standard treatment in endovascular aneurysm repair or treatment using Cydar EV, a CE-marked medical device comprising of cloud computing, augmented intelligence, and computer vision. The primary outcome is procedural time, with secondary outcomes of pro...
Source: Trials - March 25, 2024 Category: Research Source Type: clinical trials

Treatment of TASC C and D Aortoiliac Lesions
Conditions: Peripheral Arterial Disease; Aortoiliac Occlusive Disease; Leriche Syndrome; Peripheral Vascular Disease Interventions: Procedure: Open surgery; Procedure: Hybrid repair; Procedure: Endovascular repair Sponsors: Clinical Centre of Serbia; University of Belgrade; University of Trieste; Centro Hospitalar De S ão João, E.P.E.; Centro Hospitalar Universitário de Santo António; Centro Hospitalar do Tâmega e Sousa; Hospital Beatriz Ângelo; Centro Hospitalar e Universitário de Coimbra, E.P.E.; Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro; Centro Hospitalar de Vila Nova de Gaia/Espinho, E. P.E.; Cl...
Source: ClinicalTrials.gov - February 12, 2024 Category: Research Source Type: clinical trials

Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany
DiscussionAlthough preexisting studies repeatedly indicated a beneficial effect of SE on T2EL rates after EVAR, patient relevant outcomes have not been assessed until now. The present study is the first randomized controlled multicentre study to assess the impact of SE on quality of life. Further unique features include employment of easily assessable high-risk criteria, a contemporary follow-up protocol, and approval to use any commercially available coil material. Overcoming limitations of previous studies might help SE to be implemented in daily practice and to enhance patient safety.Trial registration ClinicalTrials.go...
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials

Effect of Dexamethason on Postimplantation Syndrome After EVAR
Conditions:   Aneurysm Abdominal;   Endovascular Aneurysm Repair;   Postimplantation Syndrome;   Dexamethasone Interventions:   Drug: Dexamethasone;   Other: Placebo Sponsor:   Centro Hospitalar de Lisboa Central Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - September 21, 2023 Category: Research Source Type: clinical trials

Early endovascular intervention for unfavorable remodeling of the thoracic aorta after open surgery for acute DeBakey type I aortic dissection: study protocol for a multicenter, randomized, controlled trial
DiscussionIf early minimally invasive endovascular repair could safely and effectively promote distal aortic remodeling and bring favorable long-term outcomes for patients with dominant false lumen and residual tears in the descending thoracic aorta after total arch replacement and frozen elephant trunk technique, it would improve the treatment strategy for DeBakey type I aortic dissection.Trial registrationChinese Clinical Trial Registry, CHiCTR2000030050. Registered on 11 March 2020. (Source: Trials)
Source: Trials - August 5, 2023 Category: Research Source Type: clinical trials

The Enzen Trial: Comparison of Evar Endoprosthesis: Endurant Versus Zenith
Conditions:   Aortic Aneurysm;   Aortoiliac Atherosclerosis Intervention:   Device: EVAR Sponsor:   Hospital do Servidor Publico Estadual Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - August 1, 2023 Category: Research Source Type: clinical trials