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Aortic Aneurysm clinical trials

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NCT ID: NCT05972018 Recruiting - Clinical trials for Aortic Aneurysm, Abdominal

Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters

EXODUS
Start date: October 18, 2023
Phase: Phase 4
Study type: Interventional

The goal of this randomized clinical trial is to compare single shot rectus sheath blocks of liposomal bupivacaine/bupivacaine mixture to bilateral rectus sheath catheters infused with ropivacaine (standard of care at our facility) in patients undergoing vascular surgery with an open mid-abdominal laparotomy incision. This study will examine the difference in the highest, lowest, average, and current pain scores reported at the end of 24-48 postoperative hours using the brief pain inventory-short form (BPI-SF). Participants will be randomized to either receive a single dose of liposomal bupivacaine/bupivacaine mixture intraoperatively at the end of surgery through bilateral rectus sheath blocks (LB/B group) or to receive the standard of care ropivacaine intraoperatively at the end of surgery through bilateral rectus sheath blocks with the insertion of bilateral RS catheter for continuous ropivacaine infusion plus repeated daily boluses (Catheter group; standard care). They will be assessed for a difference in postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's satisfaction, and quality of recovery. Additionally, we will examine the resources consumed by each intervention, including the medication cost (ropivacaine vs. LB/bupivacaine mixture), block and catheter supply, hospital length of stay, and anesthesia billing time.

NCT ID: NCT05954793 Recruiting - Clinical trials for Thoracoabdominal Aortic Aneurysm

A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

The INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with thoracoabdominal aortic aneurysms.

NCT ID: NCT05920317 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Comparison of a Full Automatic Software With Standard Methods of Vessels Analysis

PRAEVA-2-LP
Start date: June 16, 2023
Phase:
Study type: Observational

The treatment of aortic aneurysms is today based on different indicators (diameters, lengths, angles, volumes of the arteries) measured on CT scan images. Several indicators are time consuming and complicatated to measure. They demand training and practice. Nurea is developing a software for automatic measurement of these indicators, PRAEVAorta® 2, to facilitate and assist the physician in his clinical routine. The purpose of this study is to compare the analysis realised by the software PRAEVAorta® 2 with the analysis realised by the healthcare professional on retrospective CT scan images. Contrasted and non-contrasted, pre-operation or post-operation CT scans from 50 patients will be analysed. The main objectif is to validate the accuracy of the software by demonstrating its adequacy to the standard method of analysis. The second objectives are the following: - Evaluate the security of the software PRAEVAorta® 2 - Evaluate the unanticipated risks related to the use of the software - Validate the accessory PRAEVAorta® Web We make the following assumption : 90% of the patients show 90% of adequacy to the healthcare professional analysis

NCT ID: NCT05896397 Recruiting - Clinical trials for Thoracoabdominal Aortic Aneurysm

European Aortic Data Collection Project

EADC
Start date: May 31, 2023
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices. The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.

NCT ID: NCT05864560 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up

Start date: September 19, 2023
Phase:
Study type: Observational

The objective of the study is to collect real-world data on patient outcomes and evaluate the safety and performance of the Lifetech Ankura™ AAA Stent Graft System, Ankura™ Cuff Stent Graft System, Ankura™ AUI Stent Graft System and ZoeTrack™ Super Stiff Guidewire.

NCT ID: NCT05860452 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Effectiveness of TAP (Transversus Abdominis Plane) Block for Abdominal Aortic Surgery

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

The goal of this study is to learn about the effectiveness of TAP block for pain relief after vascular surgery on the abdominal aorta. The main question the investigators are looking to answer is whether the TAP block lowers the dose of opioid required after abdominal aortic surgery.

NCT ID: NCT05823519 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Neck Evolution With Ovation in Spain

NEOVAS
Start date: June 1, 2022
Phase:
Study type: Observational

This is a multicenter, observational, prospective, single arm registry using Ovation Alto Endograft. A minimum of 50 up to a maximum of 120 subjects undergoing endovascular repair with Ovation Alto endograft will be enrolled and followed procedurally to discharge, at 1month, 6 months, 1 year and yearly afterward up to 3 years. This registry of Ovation Alto endograft will provide further assessment to confirm continuing safety and effectiveness of the graft and to confirm the stability of the neck diameter over time when treated with this device.

NCT ID: NCT05812768 Recruiting - Clinical trials for Aortic Aneurysm, Abdominal

Suture-Tight™ First-in-Human Safety and Performance Study

Suture-Tight™
Start date: December 12, 2023
Phase: N/A
Study type: Interventional

Single center, open label, prospective, single-arm, first-in-human (FIH), pre-market clinical study with the objective of validating the safety and performance of the Suture-Tight™ Suture Delivery System in an EVAR procedure.

NCT ID: NCT05808439 Recruiting - Clinical trials for On Abdominal Aortic Aneurysms

Endovascular Repair of AAA

Start date: April 15, 2023
Phase:
Study type: Observational

We study differen t endovascular techniques as an alternative to surgical reconstruction to repair AAAS regarding ; success rates, 30-day mortality, endoleak events secondary intervention rates

NCT ID: NCT05777460 Recruiting - Aortic Diseases Clinical Trials

Mid- and Long-term Outcomes of Custom-made Aortic Devices

Start date: October 1, 2020
Phase:
Study type: Observational

This study aims to evaluate mid- and long-term outcomes after Thoracic endovascular aortic repair (TEVAR) with custom-made devices.