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Aneurysm clinical trials

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NCT ID: NCT04252079 Not yet recruiting - Clinical trials for Juxtarenal Aortic Aneurysm

Endovascular Repair of Juxtarenal Aortic Aneurysm

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The investigators compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality,endoleak events secondary intervention rates

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: NCT04246125 Completed - Lung Neoplasms Clinical Trials

Patient Skin Dose in Interventional Radiology

DPPRI
Start date: October 13, 2020
Phase:
Study type: Observational

Studies on radiation induced patients' skin lesions in interventional radiology highlighted the need for optimized and personalized patient dosimetry and adapted patient follow-up. Measurements using Gafchromic® films or thermoluminescent dosimeters have long been the only way to accurately evaluate the maximum absorbed dose to the patient skin. However as these dose measurements are tedious and expensive, they could not be systematically applicable in clinical practice. Therefore, more practical calculation methods have been developed. These software programs calculate the skin dose using dosimetric information from images DICOM header or radiation dose structured reports (RDSRs). Validation studies of these software programs are rare and when existent have many limitations. Radiation Dose Monitor (RDM from Medsquare) is a software program for archiving and monitoring of radiation dose (DACS, Dosimetry Archiving Communication System) used in routine in the investigator's hospitals. A new functionality developed in RDM allows quick estimation without in-vivo measurements of the absorbed dose to the skin of the patient. Comparing RDM calculations with in-vivo measurements will enable this software validation so that it can be used in clinical routine. Main objective: to validate RDM software for calculating patient skin dose in interventional radiology.

NCT ID: NCT04244188 Completed - Clinical trials for Aortic Arch Aneurysm

Simulation of Stent-graft Deployment in Aortic Arch Aneurysms

Start date: January 1, 2019
Phase:
Study type: Observational

Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, the investigators aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.

NCT ID: NCT04236856 Completed - Headache Clinical Trials

CorPath® GRX Neuro Study

Start date: August 21, 2020
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.

NCT ID: NCT04227054 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks

AAA-SHAPE
Start date: September 9, 2020
Phase: N/A
Study type: Interventional

To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.

NCT ID: NCT04224675 Not yet recruiting - Aneurysm Clinical Trials

Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms

Start date: March 7, 2020
Phase: N/A
Study type: Interventional

Thoracic aortic aneurysms (TAA) are considered "silent killers" because they scarcely display any symptomatology, but are correlated with significant mortality and morbidity. Current guidelines regard aortic aneurysm disease as a coronary artery disease equivalent and suggest aspirin and statin use to reduce the progression of atherosclerosis, as well as beta-blocker (BB) therapy. No therapy, however, is effective at limiting aneurysm expansion and preventing rupture, even in large trials. TAA has emerged as an inflammation-mediated disorder. Angiotensin-converting enzyme inhibitors (ACEIs) can reduce the wall shear stress and inflammation, both of which play vital roles in the expansion of the aneurysm. The study will be a randomized, double-blind trial. Patients will be randomized into one of two parallel arms, receiving captopril or atenolol. The doses of captopril and atenolol will be 25 mg daily for the first 15 days, rising to 100 mg according to clinical tolerance and BP estimates. The sample size will be set at 424 subjects (212 per group). The primary end-point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months of therapy with captopril vs. atenolol. BBs have not been precisely found to decrease aneurysm growth rates. ACEIs could lead to the prevention of aneurysm degeneration through their antihypertensive and anti-inflammatory properties. The results of this trial will clarify that ACEIs are superior to BB therapy in reducing the growth rate of TAAs, the rate of change in aortic insufficiency, the time to aortic rupture or dissection, the need for aortic surgery or intervention, and death.

NCT ID: NCT04224051 Enrolling by invitation - Clinical trials for Abdominal Aortic Aneurysm

Metformin for Abdominal Aortic Aneurysm Growth Inhibition

MAAAGI
Start date: February 12, 2020
Phase: Phase 2
Study type: Interventional

A multi-centre population-based open-label randomized controlled trial with allocation concealment and blinded outcome assessment will examine if up to 2g metformin daily slows AAA growth in patients with small AAAs who do not have diabetes.

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.

NCT ID: NCT04216433 Completed - Clinical trials for Abdominal Aortic Aneurism

A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)

AAA
Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

In the spirit of improving patient safety and quality of healthcare in our region, the Dallas-Fort Worth Hospital Council Education and Research Foundation (Foundation) and Baylor Research Institute sought and obtained federal funding support (AHRQ grant) to develop an Abdominal Aortic Aneurism (AAA) surgery registry in North Texas. Participating centers will directly benefit from this project and will have access to a de-identified version of the registry data through their collaboration. These data may be used for quality improvement initiatives and/or to conduct your own research. In summary, this effort represents a substantial investment (with no costs to facilities) in improving outcomes for patients with AAA.