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Aortic Aneurysm, Abdominal clinical trials

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NCT ID: NCT06349382 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

CArbohydrate Loading in Aortic Surgery

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The adverse effects of overnight fasting before surgery have been well-documented in the contemporary literature. Still, due to the possibility of pulmonary aspiration of gastric contents, many clinicians worldwide still employ this practice. On the other hand, the benefits of preoperative oral carbohydrate loading (OCHL) have been shown in various patient groups. Studies examining the usefulness of preoperative OCHL in aortic surgery are lacking. In particular, no randomized control trials have specifically examined the impact of preoperative OCHL on the postoperative course in patients undergoing open abdominal aortic surgery.

NCT ID: NCT06332911 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm Without Rupture

Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

TEVAR
Start date: August 1, 2024
Phase:
Study type: Observational

Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study. The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR.

NCT ID: NCT06325371 Not yet recruiting - Aneurysm Abdominal Clinical Trials

Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2

DEDICATE
Start date: April 1, 2024
Phase:
Study type: Observational

This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention. The enrollment period will be of 54 months (01/01/2020-30/06/2024). Minimum sample size will be of 50 Patients.

NCT ID: NCT06218875 Not yet recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Start date: April 2024
Phase:
Study type: Observational [Patient Registry]

A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.

NCT ID: NCT06162273 Not yet recruiting - Clinical trials for Aortic Aneurysm, Abdominal

An Exploratory Study of Iliac Artery Branch Stent for Internal Iliac Artery Reconstruction in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair

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

The purpose of this study is to evaluate the efficacy and safety of IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company in the treatment of abdominal aortic aneurysm/iliac aneurysm reconstruction of internal iliac artery

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: 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: 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: NCT05756283 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair

Start date: September 2023
Phase: N/A
Study type: Interventional

An abdominal aortic aneurysm is a condition where the major artery in the abdomen becomes larger than usual. Over time, as it continues to grow, the wall of the artery weakens and there is a risk that the artery can burst causing internal bleeding and death. Aortic aneurysms are fixed when they reach a certain size to prevent that outcome. The surgery to fix them is a major, high-risk surgery that is associated with a lot of complications and a slow recovery back to normal. The time between diagnosis and surgery is called the pre-operative period and is a key time to optimize a patient's health in order to ensure the best possible outcomes following surgery. This study will look at whether a multidisciplinary pre-operative program that involves exercise training, nutritional advice and supplementation, and psychosocial support will reduce complications following surgery. This program should decrease complications and speed up a patient's recovery back to normal after surgery. It is also a way for patients to take ownership of their disease and play an active role in their health care journey. The benefits from this program will go beyond the pre-operative time frame, as the habits and knowledge gained will improve their health over their lifetime. This study will also assess the economic impact and cost of a program like this.

NCT ID: NCT05643664 Not yet recruiting - Clinical trials for Frequency of Ischemic Complications

The Role of Artificial Intelligence in the Treatment of Abdominal Aortic Aneurysms

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

"Pilot randomized prospective clinical study of the effectiveness of the use of artificial intelligence in determining "safe" clamping zones in the surgical treatment of abdominal aortic aneurysms."