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Abdominal Aortic Aneurysm clinical trials

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NCT ID: NCT04894864 Recruiting - Postoperative Pain Clinical Trials

Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair

Start date: October 8, 2020
Phase: Phase 4
Study type: Interventional

Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.

NCT ID: NCT04811222 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

DOTATATE PETMRI AAA Study

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Abdominal Aortic Aneurysm (AAA) screening and an aging population have increased the prevalence of AAA diagnoses. Small AAAs (<5.5cm) are monitored with ultrasound. Large AAAs may rupture and this is usually fatal. Surgery is considered at a crude size threshold of 5.5cm when the annual rupture risk reaches 5%. AAA size is the only predictor of growth and rupture available but growth is non-linear and some small AAAs rupture. Thus, only 1 in 20 patients treated at 5.5cm will have benefited from rupture prevention in the year following surgery, and others may miss out on life-saving surgery. This study will develop an imaging tool PETMRI with radiotracer Ga- DOTATATE with high clinical utility, to improve prediction of aneurysm growth and risk.

NCT ID: NCT04746677 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.

NCT ID: NCT04697784 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Post-Approval Study of the TREO Abdominal Stent-Graft System

TREO PAS
Start date: January 20, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.

NCT ID: NCT04500756 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Limiting AAA With Metformin (LIMIT) Trial

LIMIT
Start date: February 28, 2022
Phase: Phase 2
Study type: Interventional

In this research, the investigators are looking at the effects of a drug called metformin may have on the growth of abdominal aortic aneurysm (AAA)s. AAA is an abnormal enlargement of the aorta, which is the large artery in the abdomen (stomach area). The enlargement of the aorta carries a risk that it will rupture and cause life-threatening bleeding in the abdomen (belly). In this study the investigators hope to learn how metformin is associated with the enlargement or change in size of the AAA in study participants. Smaller studies have suggested that metformin may reduce the rate at which aortic aneurysms enlarge. This study will test this question: does metformin prevent AAAs from growing larger?

NCT ID: NCT04444999 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Carbon Dioxide Guided Angiography in Endovascular Abdominal Aortic Aneurysm Repair

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Endovascular aneurysm repair (EVAR) has lower short-term morbidity and mortality than open surgery. Intra-arterial contrast agents are an important component of successful EVAR as the tool of choice for preoperative evaluation of aortic aneurysm morphology as well as precise sizing and intraoperative visualization of the ostia of the renal and hypogastric arteries for graft replacement. Although iodinated contrast (IC) is overwhelmingly the most common contrast agent, the perioperative use of IC agents is not recommended in patients with renal dysfunction or allergies to IC The aim of this study was to evaluate feasibility, efficacy and safety of carbon dioxide (CO2) digital subtraction angiography (DSA) to guide endovascular aneurysm repair (EVAR) in a cohort of patients with abdominal aortic aneurysm

NCT ID: NCT04422054 Recruiting - Surgery Clinical Trials

Aneurysm Diameter and Surgical Outcome

ADASO
Start date: January 2, 2020
Phase:
Study type: Observational

Aneurysm diameter is an important risk for rupture and related death in affected patients. This study will evaluate whether aneurysms size may even influence post procedural outcomes both in open surgical repair and in end-vascular aneurysm repair. We will retrospectively review clinical data of operated patients with abdominal aortic aneurysm. We will consider both open surgical repair and endovascular aneurysm repair procedures in order to assess the influence of aneurysm size at the time of intervention.

NCT ID: NCT04307992 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

AneuFix - Prophylactic Sac Filling

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.

NCT ID: NCT04246463 Recruiting - Surgery Clinical Trials

Terumo Aortic Global Endovascular Registry

TiGER
Start date: December 17, 2019
Phase:
Study type: Observational

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

NCT ID: NCT04220177 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAA

Start date: December 11, 2019
Phase: N/A
Study type: Interventional

This is a Prospective, Open-label, Multicenter, and Non-randomized Clinical Study. The main purpose of this study is to establish the efficacy and safety of a medical device system, SETA LATECBA Stent Graft, intended for the treatment of EVAR of pararenal AAA (patients with complex anatomy, not eligible for other surgical procedure).Other objective is to evaluate the technical performance of the device SETA LATECBA Stent Graft.