A Comparison of Carotid Artery Stent Placement Performed within and outside Clinical Trials in the United States (IN2-1.007)

Background: Carotid angioplasty and stenting (CAS) has emerged as a less invasive treatment alternative to carotid endarterectomy and the frequency of CAS is increasing. A large scale analysis of the device malfunction related adverse events associated with carotid stenting has not previously been undertaken. Methods: Adverse events reported to the United States FDA Manufacturer and User Facility Device Experience were analyzed. This data includes voluntary reporting of adverse events related to medical device use. We analyzed the characteristics of device related adverse events which included hypotension, bradycardia, hyperperfusion syndrome, transient ischemic attack (TIA), stroke, carotid artery spasm, myocardial infarction, cardiac arrest, and vessel dissection from 2010 to 2012 in the United States. Results: From 2010 to 2012, there were a total of 1211 adverse events reported to the FDA related to CAS. The most common adverse event was stroke, which represented 39.3% of the clinical adverse events. Adverse device deployment was most commonly affected by intraprocedural malfunction of the stent, which occurred in 22.0% of reported events, followed by incomplete coverage by the stent requiring a second stent, 15.5% of events. In addition, vessel tortuosity, 11.0% of events, and vessel calcification, 4.5%, played a role in adversely affecting stent deployment. The stents most commonly involved in intraprocedural malfunction were the Carotid Wall Monorail stent and the Acculink carotid stent, which represented 29.5% and 30.8% of the failures respectively. The clinical events associated with device malfunction were stroke (n=464), TIA (n=186), carotid artery spasm (n=30), and carotid dissection (n=8). Conclusions: This is the first large scale study to report on the device malfunction related adverse events associated with carotid stent placement. The most common device complication relates to intraprocedural malfunction of the stent, which represents 22% of reported failures.

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Abstract 154: A Comparison of Carotid Artery Stent Placement Performed Within and Outside Clinical Trials in the United States

Stroke ◽

10.1161/str.43.suppl_1.a154 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Haitham M Hussein ◽

Saqib A Chaudhry ◽

Shahram Majidi ◽

Rakesh Khatri ◽

Gustavo J Rodriguez ◽

...

Keyword(s):

United States ◽

Clinical Trial ◽

Clinical Trials ◽

Hospital Mortality ◽

Stent Placement ◽

The United States ◽

Cardiac Events ◽

Hospital Outcomes ◽

End Point ◽

National Cohort

Background: A discrepancy between characteristics of patients treated with carotid angioplasty and stent placement (CAS) within and outside clinical trials, particularly characteristics with direct impact on clinical outcome, may lead to reduction in anticipated benefit. Objective: To identify differences in demographic and clinical characteristics and outcomes related to CAS in patients treated within clinical trials and those treated outside clinical trials in a large national cohort. Methods: We determined the frequency of CAS performed within and outside clinical trials and associated in-hospital outcomes using data from the Nationwide Inpatient Survey (NIS) data files from 2005 to 2008. All the in-hospital outcomes were analyzed after adjusting for potential confounders using multivariate analysis. Results: Of the 47,899 patients who underwent CAS, 16,078 (1%) underwent the procedure as part of a clinical trial. The mean age of the patients was significantly lower in patients treated with CAS as part of a clinical trial than those treated with CAS outside a clinical trial. The proportion of women and non-whites was lower among patients treated with CAS as part of a clinical trial. The in-hospital mortality was two folds higher among patients treated with CAS outside clinical trial (1.12% versus 0.53%, p=0.0.0005). The rate of composite end-point of stroke, cardiac events, and death was significantly higher among patients treated with CAS outside clinical trials (p=0.02). After adjusting for age, gender, presence of hypertension, diabetes mellitus, renal failure, congestive heart failure, and hospital teaching status, CAS performed as part of clinical trial was associated with lower rates of in-hospital mortality (OR 0.349, 95% CI 0.219-0.555)(p<0.0001) and composite end point of stroke, cardiac events, and death (OR 0.349, 95% CI 0.219-0.555)(p<0.0001) . Conclusions: Our results suggests that CAS performed as part of clinical trial was associated with lower rates of in-hospital mortality and composite end point of stroke, cardiac events, and death in United States. These findings highlight the need for strategies that ensure appropriate adoption of CAS to ensure that the benefits observed in clinical trials can be replicated in general practice.

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Developing a Clinical Trials Infrastructure in the United States

NAM Perspectives ◽

10.31478/201205g ◽

2012 ◽

Vol 2 (5) ◽

Author(s):

Paul Eisenberg ◽

◽

Petra Kaufmann ◽

Ellen Sigal ◽

Janet Woodcock ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

The United States

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690 Are participants in obstetrical randomized clinical trials representative of the United States pregnant population?

American Journal of Obstetrics and Gynecology ◽

10.1016/j.ajog.2020.12.714 ◽

2021 ◽

Vol 224 (2) ◽

pp. S433

Author(s):

Cynthia Coots ◽

Stephen Wagner ◽

Matthew J. Bicocca ◽

Megha Gupta ◽

Hector Mendez Figueroa ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

The United States

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EPID-07. ACCESS TO GLIOBLASTOMA CLINICAL TRIALS FOR RURAL PATIENTS IN THE UNITED STATES FROM 2010–2020

Neuro-Oncology ◽

10.1093/neuonc/noaa215.325 ◽

2020 ◽

Vol 22 (Supplement_2) ◽

pp. ii79-ii79

Author(s):

Kathryn Nevel ◽

Samuel Capouch ◽

Lisa Arnold ◽

Katherine Peters ◽

Nimish Mohile ◽

...

Keyword(s):

United States ◽

Clinical Trials ◽

Rural Communities ◽

The United States ◽

Interventional Treatment ◽

Phase Ii Trials ◽

Treatment Trials ◽

Rural Sites ◽

Rural Patients ◽

Urban Sites

Abstract BACKGROUND Patients in rural communities have less access to optimal cancer care and clinical trials. For GBM, access to experimental therapies, and consideration of a clinical trial is embedded in national guidelines. Still, the availability of clinical trials to rural communities, representing 20% of the US population, has not been described. METHODS We queried ClinicalTrials.gov for glioblastoma interventional treatment trials opened between 1/2010 and 1/2020 in the United States. We created a Structured Query Language database and leveraged Google application programming interfaces (API) Places to find name and street addresses for the sites, and Google’s Geocode API to determine the county location. Counties were classified by US Department of Agriculture Rural-Urban Continuum Codes (RUCC 1–3 = urban and RUCC 4–9 = rural). We used z-ratios for rural-urban statistical comparisons. RESULTS We identified 406 interventional treatment trials for GBM at 1491 unique sites. 8.7% of unique sites were in rural settings. Rural sites opened an average of 1.7 trials/site and urban sites 2.8 trials/site from 1/2010–1/2020. Rural sites offered more phase II trials (63% vs 57%, p= 0.03) and fewer phase I trials (22% vs 28%, p= 0.01) than urban sites. Rural locations were more likely to offer federally-sponsored trials (p< 0.002). There were no investigator-initiated or single-institution trials offered at rural locations, and only 1% of industry trials were offered rurally. DISCUSSION Clinical trials for GBM were rarely open in rural areas, and were more dependent on federal funding. Clinical trials are likely difficult to access for rural patients, and this has important implications for the generalizability of research as well as how we engage the field of neuro-oncology and patient advocacy groups in improving patient access to trials. Increasing the number of clinical trials in rural locations may enable more rural patients to access and enroll in GBM studies.

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The United States’ Regulatory Environment Is Evolving to Accommodate a Coming Boom in Gene Therapy Research

Applied Biosafety ◽

10.1177/1535676019854866 ◽

2019 ◽

Vol 24 (3) ◽

pp. 147-152 ◽

Cited By ~ 2

Author(s):

Daniel Eisenman

Keyword(s):

United States ◽

Gene Therapy ◽

Clinical Trials ◽

The United States ◽

Regulatory Environment ◽

Evidence Based ◽

Regulatory Structure ◽

Regulatory Changes ◽

Current State ◽

Therapy Field

Introduction: A dramatic increase in the number of clinical trials involving gene-modified cell therapy and gene therapy is taking place. The field is on the verge of a boom, and the regulatory environment is evolving to accommodate the growth. Discussion: This commentary summarizes the current state of the field, including an overview of the growth. The United States (US) regulatory structure for gene therapy will be summarized, and the evolution of the oversight structure will be explained. Conclusion: The gene therapy field has recently produced its first FDA-approved therapeutics and has a pipeline of other investigational products in the final stages of clinical trials before they can be evaluated by the FDA as safe and effective therapeutics. As research continues to evolve, so must the oversight structure. Biosafety professionals and IBCs have always played key roles in contributing to the safe, evidence-based advancement of gene therapy research. With the recent regulatory changes and current surge in gene therapy research, the importance of those roles has increased dramatically.

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