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Aortic Aneurysm, Abdominal clinical trials

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NCT ID: NCT03987035 Active, not recruiting - Clinical trials for Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture

BGP Stent as Bridging Stent in FEVAR

Start date: March 18, 2021
Phase: Phase 3
Study type: Interventional

The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and performance of the BeGraft Peripheral (BGP) balloon expandable covered stent Graft System (Bentley InnoMed, Hechingen, Germany) implanted as bridging stent in FEVAR (fenestrated endovascular aortic repair) for complex aortic aneurysms.

NCT ID: NCT03743142 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm (AAA)

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms

EXCeL
Start date: September 11, 2018
Phase:
Study type: Observational [Patient Registry]

EVAR continues to evolve as a treatment option for AAA. New devices which are specifically designed to perform adequately across the spectrum of potential anatomic presentations for infrarenal EVAR are needed. The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the EXCeL Registry. This study will assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (CEXC Device) in patients who meet the IFU anatomic criteria (≥15mm proximal neck length and ≤90˚ proximal neck angulation; and ≥10mm proximal neck length and ≤60˚ proximal neck angulation) and in patients with challenging anatomic presentation that may present outside the IFU anatomic criteria. Successful outcomes from this study will provide evidence to support the CEXC Device as an option for expanding EVAR to a broader patient population with more challenging anatomic presentations.

NCT ID: NCT03687489 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System

Start date: September 30, 2018
Phase: N/A
Study type: Interventional

A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the infrarenal abdominal aortic aneurysm.

NCT ID: NCT03507413 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Metformin Therapy in Non-diabetic AAA Patients

MetAAA
Start date: September 26, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

A prospective randomized, double blind, placebo-controlled, safety and efficacy study of metformin as add-on therapy in abdominal aortic aneurysm (AAA) OBJECTIVES Primary Objective - To demonstrate treatment efficacy of metformin in AAA in comparison to placebo or active comparator, as measured by growth of the AAA maximum diameter at 12 months Secondary Objectives - To asses inflammatory cytokines and parameters of neutrophil activation in AAA in response to metformin treatment by glucose - insulin - Interleukin-6 - markers of neutrophil activation (MPO, elastase, NGAL)

NCT ID: NCT03431038 Active, not recruiting - Clinical trials for Sleep Apnea, Obstructive

Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH

Start date: September 1, 2017
Phase: N/A
Study type: Observational

This study explore AAA prevalence in OSAHS patients by ultrasound screening and try to analysis risk factors of AAA in OSAHS patients.

NCT ID: NCT03426839 Active, not recruiting - Clinical trials for Perioperative/Postoperative Complications

Haemostasis Management of Abdominal Aortic Procedures

Start date: May 2016
Phase: N/A
Study type: Interventional

Comparative study on efficacy of haemostatic therapy guided either by standard laboratory coagulation parameters or point-of-care testing in patients undergoing vascular surgical procedures. We investigate the amount of perioperative bleeding and the number of blood product used. Inclusion criteria Patients scheduled for elective and acute open aorta surgery or undergoing acute aorta surgery with minimally invasive techniques and were provided treatment in the operating theatre and/or ICU attached to perioperative care, they must be at least 18 years of age and written informed consent was obtained from the patient or his/her legal representative. Randomisation technique Patients will be randomly assigned to each of two treatment groups using sealed envelopes. In group 1 (G1) haemostasis strategy guided by conventional coagulation tests, while in group 2 (G2) transfusion algorithms guided by point-of-care (POC) tests will be carried out. Sampling techniques and measurements For assessment of monitored parameters shall be used arterial or venous blood depending on the catheter placed preoperatively. In case of the above mentioned vascular surgical procedures, all patients will receive arterial cannula routinely, and, depending on the extension of procedure, as appropriate, a central venous catheter will be inserted as well. Sampling in the patient groups shall be performed as follows: - pre- and postoperative evaluation of standard laboratory parameters in all patients - evaluation of standard laboratory parameters and arterial Astrup test during and after surgery in group 1, if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes - in case of elective surgery: thromboelastometry and arterial Astrup test during and after surgery in group 2 if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes - in case of acute surgery: thromboelastometry and arterial Astrup test before, during and after surgery in group 2 - in case of positive anamnesis, preoperative platelet aggregation test in both groups Besides the above samplings, routine lab tests (blood gas, blood count, sodium (Na), potassium (K), parameters of renal and liver function, clotting and inflammation, lactic acid, blood sugar) will be performed every day as usual during intensive therapy.

NCT ID: NCT03425305 Active, not recruiting - Heart Failure Clinical Trials

Serum Uric Acid Levels and Onset of Cardiovascular Diseases: a CALIBER Study

Start date: January 1998
Phase: N/A
Study type: Observational

Serum uric acid level is a commonly measured biomarker. The association between serum uric acid level and the risk of developing cardiovascular diseases has been observed in some studies, while others showed controversial results. Estimation of this association may help to predict cardiovascular outcomes and may guide new treatment strategies. The hypothesis is that increased serum uric acid level is associated with a range of cardiovascular diseases.

NCT ID: NCT03298477 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm Without Rupture

EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

EVAS2
Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

NCT ID: NCT03180996 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Global Fenestrated Anaconda Clinical sTudy

Global FACT
Start date: September 11, 2017
Phase:
Study type: Observational

This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.

NCT ID: NCT03115346 Active, not recruiting - Clinical trials for Abdominal Aortic Aneurysm

Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm

PROVE-AAA
Start date: April 15, 2017
Phase: N/A
Study type: Interventional

This study tests the use of a decision aid for Veterans who are facing a decision about surgery for their Abdominal Aortic Aneurysm (AAA). The local site investigators (LSI) will enroll Veterans with AAA who are candidates for endovascular or open surgical repair. There are 22-24 VA Medical Centers participating in the trial. 12 sites will be randomly assigned to the intervention group, and 12 sites will be randomly assigned to the control group. Twelve Veterans will be enrolled at each site. At sites assigned to the intervention arm, Veterans will receive a decision aid with information about the two types of surgery for AAA repair, open and endovascular, and complete a survey about their preferences. Veterans at control sites will complete the same survey, but will not receive the decision aid. After their surgery, Veterans will take another survey asking about their satisfaction. The LSI will compare the results of the survey between Veterans' in the intervention and control groups to determine the effect of the decision aid on agreement between preference and repair type.