betty and guy beatty center for integrated - Inova Health System

I NTERVENTIONAL RADIOLOGY
In 2009, there were a number of industry sponsored research protocols carried out by members of Interventional
radiology. The following is a summary of these protocols:
1. Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)
� Prospective, multicenter, unblinded, two arm, randomized trial designed to test the hypothesis that
medical therapy with stenting of hemodynamically significant (angiographically documented) renal artery
stenosis in patients with systolic hypertension reduces the incidence of cardiovascular and renal events com
pared with medical therapy alone.
� Primary Endpoint: Event-free survival from cardiovascular and renal adverse events defined as a composite
of cardiovascular or renal death, stroke, MI, hospitalization for CHF, progressive renal insufficiency, or need
for permanent renal replacement therapy.
� Enrollment goal 1080 subjects with 200 sites internationally.
��Follow subjects for up to 5 years, closely monitoring for blood pressure control and management of other
risk factors.
A subgroup of 400 patients will undergo renal artery Duplex ultrasound at baseline, 1 year and study termination.
2. CRUX Biomedical Evaluation of the Crux Inferior Vena Cava Filter System � ������������
� This is an open label, non-randomized, prospective, multicenter study.
� Primary Efficacy Objective: To describe the clinical utility of the Crux IVCF by the following criteria: Ab-
sence of a recurrent PE and IVC thrombosis related to the Crux IVCF
� Primary Safety Objective: To estimate the proportion of patients who experience device/procedure related
complications associated with the Crux IVCF. 104 patients considered to be at risk for PE are expected to be
enrolled in this study. It is anticipated that approximately 30 patients will undergo retrieval of the implanted filter.
3. SIR-Spheres Registry
�� Nationwide registry for all subjects undergoing SIR-Spheres procedure
�� The purpose of the Registry is to build a Phase IV (i.e., post-marketing) database of patient demographics, primary and secondary diagnoses,
treatment details, complications and patient outcomes. The data will be used to further evaluate and analyze patient outcomes from SIR-���������
therapy.
In addition, de-identified, aggregate data may be used in discussions with regulatory authorities, public and private payers/insurers, policy-makers, and others.
�� ��������������������������������������������������������������������������������������������
dressed in accordance with
Sirtex policy and reported to the FDA in accordance with legal and regulatory requirements.
4. Therasphere HDE
�� A Humanitarian Device Exemption Use Protocol of TheraSphere or Treatment of Unresectable Hepatocellular Carcinoma
�� Post-Marketing: TheraSphere commercially distributed under HDE # 980006
�� Objectives-Provide supervised access to TheraSphere therapy at this institution, evaluate response to treatment, toxicities and adverse experiences
associatedwith TheraSphere treatment, and survival time
�� Endpoints- Proportion of patients completing scheduled treatment plan,
�� Efficacy: Response to Treatment, Survival Time from First Treatment
�� Safety: Adverse Experiences
The research team did not submit a list of publications and presentations.
P AGE 43