Objective: The aim was to evaluate renal related outcomes in patients who had incorporation of a small (<4.0 mm) renal artery (RA) during fenestrated-branched endovascular aortic repair (F-BEVAR).
Methods: A total of 215 consecutive patients enrolled in a prospective F-BEVAR trial were reviewed. Computed tomography angiography centreline of flow reconstruction was used to measure mean RA diameter. Patients who had at least one <4.0 mm main or accessory RA incorporated by fenestration or directional branch (study group) were compared with patients who had incorporation of two ≥5.0 mm RAs (control group). Endpoints were technical success of RA incorporation, RA rupture and kidney loss, primary and secondary RA patency, RA branch instability and re-interventions, and renal function deterioration.
Results: Twenty-four patients with 28 <4.0 mm RAs (16 accessory and 12 main RAs) were compared with 144 patients with 288 ≥5.0 mm incorporated RAs. Study group patients were significantly younger than controls (72 ± 8 vs. 75 ± 8 years, p = .04) and more often females (46% vs. 21%, p = .018); there were no differences in cardiovascular risk factors and aneurysm extent. Technical success was 92% for <4.0 mm and 99% for ≥5.0 mm RA incorporation (p = .05). Inadvertent RA rupture occurred in three patients in the study group (13%) and in one (1%) in the control group (p = .009) resulting in kidney loss in two study group patients (8%) and one (1%) control group patient (p = .05). At one year, primary patency was 79 ± 9% vs. 94 ± 1% (p < .001) and secondary patency was 84 ± 8% vs. 97 ± 1% (p < .001) for study vs. control group; freedom from branch instability was 79 ± 9% vs. 93 ± 2% (p = .005), respectively. There were no differences in re-intervention rates and renal function deterioration between the groups. The mean follow up time was 21 ± 14 months.
Conclusion: Incorporation of <4.0 mm RAs during F-BEVAR is associated with lower technical success, higher risk of arterial disruption and kidney loss, and lower patency rates at one year.
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http://dx.doi.org/10.1016/j.ejvs.2020.02.015 | DOI Listing |
Background: Clinical outcome assessments (COAs) are an important part of clinical trials to measure what is meaningful to patients and caregivers. This study aimed to examine trends in Alzheimer's Disease (AD) COAs used in clinical trials, given the FDA's recent emphasis on patient-focused drug development and early AD.
Method: ClinicalTrials.
Background: Clinical trial sponsors rely on research sites to identify and enroll appropriate study participants and to correctly and reliably assess symptom severity and function over the course of the trial. Low-recruiting sites represent a large financial and operational burden and may negatively impact trial success either by selecting inappropriate participants and/or high prevalence of data quality issues. We previously reported that >60% of sites in schizophrenia clinical trials recruited ≤5 participants.
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View Article and Find Full Text PDFAlzheimers Dement
December 2024
Applied Medical Sciences, Misr University for Science and Technology, Cairo, Egypt.
Background: Gamma desynchronization is an early pathophysiological event in Alzheimer's disease with a disturbance in oscillation in the gamma frequency range 30-80 Hz. This disruption was found to be directly related to the disease progression and severity. Thus, the use of transcranial alternating current stimulation (tACS) possessed greater interest.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, USA.
Background: Participant dropout from study treatment in a clinical trial can leave a trial underpowered, produce bias in statistical analysis, and limit interpretability of study results. Retaining participants in clinical trials for the full study duration is therefore as important as participant recruitment. This analysis aims to identify the baseline characteristics of participants who discontinued during the blinded phase of one of the first and largest preclinical AD trial completed to date, the Anti-Amyloid treatment in Asymptomatic AD (A4) Study.
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