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Aneurysm clinical trials

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NCT ID: NCT06118840 Not yet recruiting - Clinical trials for Intracranial Aneurysm

IDEAL Study: Blinded RCT for the Impact of AI Model for Cerebral Aneurysms Detection on Patients' Diagnosis and Outcomes

IDEAL
Start date: December 2023
Phase: N/A
Study type: Interventional

This study (IEDAL study) intends to prospectively enroll more than 6800 patients who will undergo head CT angiography (CTA) scanning in the outpatient clinic. It will be carried out in 25 hospitals in more than 10 provinces in China. The patient's head CTA images will be randomly assigned to the True-AI and Sham-AI group with a ratio of 1:1, and the patients and radiologists are unaware of the allocation. The primary outcomes are sensitivity and specificity of detecting intracranial aneurysms. The secondary outcomes focus on the prognosis and outcomes of the patients.

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: 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: 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.

NCT ID: NCT05959759 Not yet recruiting - Clinical trials for Intracranial Aneurysm

Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.

Start date: July 31, 2023
Phase: Phase 4
Study type: Interventional

This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.

NCT ID: NCT05914636 Not yet recruiting - Clinical trials for Intracranial Sacciform Aneurysm

Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm

AneBiote
Start date: August 31, 2024
Phase:
Study type: Observational

The physiopathology of intracranial aneurysm from initiation to ruptured is incompletely understood but included inflammation. The microbiota is known to interact with brain and can promote inflammation. The objective of this study is to describe microbiota with taxonomic and metabolomic analysis. A comparison between ruptured and unruptured intracranial aneurysm will be performed. The study hypothesis is that microbiota is different between ruptured and unruptured patient.

NCT ID: NCT05907902 Not yet recruiting - Clinical trials for Intracranial Aneurysm

Aspirin Treatment for Small Unruptured InTracranial Aneurysms With Ischemic cereBrovascuLar diseasE

AT-SUITABLE
Start date: July 1, 2023
Phase: Phase 3
Study type: Interventional

The management of small unruptured intracranial aneurysms (UIA) with ischemic cerebrovascular disease (ICVD) has been a very controversial topic in neurosurgery. Thus, we initiated a multicenter, prospective, randomized controlled trial (PROBE) design to elucidate in UIA patients with ICVD who do not qualify for preventive endovascular or neurosurgical intervention whether aspirin treatment decreases the risk of aneurysm growth and rupture.

NCT ID: NCT05880680 Not yet recruiting - Aneurysm Clinical Trials

SEAL™ ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry

SEAL™ ME
Start date: June 15, 2023
Phase:
Study type: Observational [Patient Registry]

Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System.