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Aneurysm clinical trials

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NCT ID: NCT06103942 Not yet recruiting - Clinical trials for Thoracoabdominal Aortic Aneurysm

Automated Carbon Dioxide Angiography in Fenestrated/Branched Endovascular Abdominal Aortic Aneurysm Repair

Start date: November 1, 2023
Phase:
Study type: Observational

Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent. Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for vascular imaging and endovascular procedures. Fenestrated and branched endovascular aortic repair (F/B-EVAR) for thoracoabdominal aortic aneurysms (TAAAs) is nowadays considered the treatment of first choice, due to its reduced procedure-related morbidity and mortality, when compared to open repair. A peculiarity of these procedures is the need of high volumes of contrast media, which are not needed in case of open repair. This increases the related risk of impaired kidney function at the short- and long-term. The present study will specifically examine the safety of the use of CO2 as intra-arterial contrast agent using the Angiodroid automated CO2-injection system during F/B-EVAR procedures. Furthermore, the current study will focus on image quality during the different steps of the procedure with the aim of standardize injection parameters (volume and pressure) for the detection of the ostium of the visceral vessels as well as of the iliac arteries, all defined as target vessels.

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: NCT06094127 Recruiting - Clinical trials for Thoracic Aortic Aneurysm

Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

Start date: July 6, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft [ZTA]) and collect longer term follow-up to better understand clinical outcomes associated with the expected lifetime of the device.

NCT ID: NCT06081153 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

Mechanistic Clinical Trial of PCSK9 Inhibition for AAA

Start date: July 1, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this mechanistic clinical trial is to assess whether lowering the low-density lipoprotein cholesterol (LDL-C) levels in the blood with the injections of the medication evolocumab will have any effect on the tissue or cells of patients with abdominal aortic aneurysm (AAA). Researchers will compare participants receiving evolocumab injections to participants receiving placebo injections to see how the tissue and cells of the aorta are affected by changes in LDL-C levels.

NCT ID: NCT06064435 Not yet recruiting - Clinical trials for Intracranial Aneurysm

Endovascular Coiling Using Target Tetra® Coils for Small Intracranial Aneurysm

Start date: December 2023
Phase:
Study type: Observational

The goal of this study was to verify the safety and effectiveness of Target Tetra® Detachable Coil in the endovascular embolization treatment of small intracranial aneurysm (≤5mm).

NCT ID: NCT06062524 Recruiting - Clinical trials for Aortic Dissection Aneurysm

Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System

Start date: October 24, 2023
Phase: N/A
Study type: Interventional

A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting aneurysm of descending thoracic aorta after aortic dissection repair.

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: NCT06057987 Recruiting - Clinical trials for Coronary Artery Ectasia

Coronary Artery Ectasia Database - Poland

CARED-POL
Start date: July 14, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to comprehensively investigate the current prevalence, morphological characteristics, risk factors for the development, complications as well as long-term prognosis of coronary artery aneurysm and ectasia (CAAE) in the Polish population. Data obtained from the CARED-POL Registry will enable the selection of morphological risk factors for the unfavorable course of CAAE, including the progression and development of giant aneurysms, aneurysm clotting with vessel occlusion, and thromboembolic complications. Comparing the safety and effectiveness of available CAAE treatment methods in individual patient subgroups will allow individualization of treatment, including anticoagulant therapy.

NCT ID: NCT06047951 Recruiting - Clinical trials for Intracranial Aneurysm

Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial

BLAST
Start date: January 10, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to confirm the feasibility and safety of performing radiosurgery on unruptured, low-risk aneurysms in humans. Participants will choose if they want to undergo radiosurgery or not. Participants who choose not to have radiosurgery will be assigned to the observational group. Participants who choose to have radiosurgery performed will be assigned to the radiosurgery group. Participants in both groups will attend an initial exam session as well as four follow-up sessions: Day 0 - Initial questionnaire - CTA scan - MRI - Radiosurgery performed on patients in the radiosurgery group 6 months - CTA scan - Follow-up questionnaire 12 months - CTA scan - MRI - Follow-up questionnaire 24 months - CTA scan - Follow-up questionnaire 36 months - CTA scan - MRI - Follow-up questionnaire Researchers will compare the observational group and the radiosurgery group to see if there is a difference in the incidence of aneurysm rupture during the study period (3 years). The hypothesis is that radiosurgery should not increase the risk of aneurysm rupture.

NCT ID: NCT06044480 Not yet recruiting - Dexamethasone Clinical Trials

Effect of Dexamethason on Postimplantation Syndrome After EVAR

DEPOS
Start date: November 1, 2023
Phase: Phase 4
Study type: Interventional

This study is a multi center double-blinded randomized controlled superiority trial, comparing the effects on postimplantatrion syndrome of a single preoperative dose of dexamethasone vs. standard treatment in endovascular aneurysm repair. Participating researchers must be vascular surgeons or vascular anesthesiologists certified by national entities. Recruitment is expected to begin in the second semester of 2023. The trial will follow the ICH-GCP guidelines and national and international legislation and reporting will be performed according to CONSORT 2010 guidelines. Site inclusion requires hospital ethics committee approval. Written informed consent is mandatory for all patients and the information and consent forms must be approved by Institutional Ethics Committee.