
Clinical
Research
Currently, the Division, in conjunction with the Keck School
of Medicine, has the following research studies that are we actively
screening for and enrolling participants in. Persons requesting
additional information or are interested in potential participation
are encouraged to call (323) 442-5752.
Link: V. Joy Hunt,
RN, MSN
Carotid Revascularization Endarterectomy versus Stenting
Trial (CREST)ProColŪ Vascular Access Bioprosthesis
Sponsor - NIH/NINDS/UMDNJ
Facility - USC University Hospital and LAC+USC Medical Center
Principal Investigator - Fred A. Weaver, MD, MMM
The purpose of this study is to compare results of treating
narrowing of carotid arteries (carotid stenosis) with either carotid
endarterectomy (surgery) or carotid stenting (metal device placed
inside the narrowing of the carotid artery during an arteriogram).
Enrolled subjects will receive extensive follow-up for 5 years
or until the end of the study.
This study has 2 phases. All participants of the first phase
(Lead-In Phase), if they meet criteria, will receive a carotid
stent that has been approved by the Food and Drug Administration
(FDA) to treat the narrowed carotid artery. During this phase,
additional information about the use of the carotid stent, the
stenting procedure and the use of a clot protection device will
be collected. Although USC continues to enroll subjects into this
phase of the trial, our focus is now on enrolling subjects into
the second phase, which is the primary focus of this study.
The second phase (Randomization Phase) compares results of treating
carotid stenosis with either carotid endarterectomy (surgery)
or carotid stenting. Participants who meet criteria and consent
to participate in this phase will be randomly assigned to one
of the two treatments. The CREST physicians hope to enroll 18
subjects per year.
We are looking to enroll participants who:
- are 18 years of age or older
- have known carotid artery stenosis
- are symptomatic (as evidenced by transcient ischemic attack
or stroke) or asymptomatic (without symptoms)
- can tolerate aspirin, Plavix or Ticlid (blood thinning medications)
Evaluation of Alfimeprase in Patients with Acute
Peripheral Arterial Occlusion
Sponsor - Nuvelo, Inc.
Facility - USC University Hospital
Principal Investigator - Fred A. Weaver, MD, MMM
The purpose of this study is to compare the safety and effectiveness
of an experimental "thrombolytic" or clot dissolving drug (Alfimeprase)
versus a placebo in dissolving an acute blood clot and restoring
blood flow to the leg. Although Alfimeprase is an experimental
drug, the FDA is permitting its use in this research study. Participants
who meet criteria and consent to participate in this trial will
be randomly assigned to one of three treatments.
We are looking to enroll participants who:
- have onset of affected leg symptoms within 14 days of treatment
- are male or female of any race or ethnicity
- are 18 years of age or older
- are not pregnant, lactating or women of child-bearing potential
Use of Recombinant Human Thrombin (rhThrombin) to
Stop Bleeding During Vascular Surgery
Sponsor - ZymoGenetics, Inc.
Facility - USC University Hospital and LAC+USC Medical Center
Principal Investigator - Fred A. Weaver, MD, MMM
The purpose of this study is to evaluate the safety of rhThrombin
and to compare how well it works to a commonly used drug to stop
bleeding during either peripheral arterial bypass surgery to restore
blood flow to the leg or surgery to establish a vascular access
for hemodialysis. The physicians hope to enroll about 40 subjects
over the next 3 months.
We are looking to enroll participants who:
- are undergoing either peripheral arterial bypass surgery or
having a vascular access placed for hemodialysis
- are 18 years of age or older
- are not pregnant within 14 days of the treatment
Heparin Induced Thrombocytopenia (HIT) after Vascular
Surgery
Sponsor – USC
Facility – USC University Hospital and LAC+USC Medical Center
Principal Investigators – Fred A. Weaver, MD, MMM and Howard
Liebman, MD
The purpose this study is to evaluate the incidence of Heparin-Platelet
Factor 4 antibodies (HIT antibodies), an acquired autoimmune thrombotic
(clotting) disorder, occurring in patients after peripheral arterial
bypass surgeries and their role in early graft failure (closure)
and other thrombotic complications.
We are looking to enroll participants who:
- are age 18 years or older
- have known atherosclerotic occlusive vascular disease (blocked
arteries to the legs requiring surgery to restore blood flow)
Upcoming Trials with Possible Enrollment Opportunities
The following are research studies that the USC Vascular Surgeons
are looking to participate and enroll participants in the very near
future. If interested, please contact V. Joy Hunt, RN, MSN for more
information or to be added to the waiting list:
- Early Endovascular Treatment of Abdominal Aortic
Aneursysms (PIVOTAL)
The purpose of this trial is to compare endovascular (inside
the artery) aneurysm repair using the AneuRx Stent Graft System
versus surveillance (monitoring) in participants with smaller
(4-5 cm) diameter abdominal aortic aneurysms (AAA).
- Treatment of Thoracic Aneurysms with the Valiant
Thoracic Stent Graft System
- Catheter-Directed Thrombolysis of Acute Venous
Thrombosis
- New Treatment Option for Varicose Vein Sclerosis
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