Vascular Surgery Associates (VSA) has a long
tradition of publishing clinical research based
on reviews of standard surgical procedures.
Over one hundred scientific papers have been
published by the members of VSA on a variety
of vascular surgical topics. Recent involvement
with multi-institutional clinical trials provides
access to exciting new therapies before these
treatments become widely available.
For
information regarding any trial, contact our
research coordinator 310-652-8132
Trial
status as of July 10, 2006
Trial
Name: NAPA-3: A Phase III, multicenter, multi-national,
randomized, double-blind, placebo-controlled
study to evaluate the efficacy and safety of
Alfimeprase in subjects with acute peripheral
arterial occlusion.
Sponsor:
Nuvelo
Inc.
Status: Open to enrollment 3rd quarter 2006
Summary:
Blood clots or thrombosis are a leading cause
of death and illness. Currently there are few
fast and safe ways to dissolve these clots without
surgery. The purpose of this study is to test
the safety and effectiveness of an experimental
drug designed to dissolve blood clots in the
circulation.
Eligible
Patients: Patients who developed blocked
arteries who would require treatment for moderate
to severe lack of circulation.
Trial Name: A Phase III, Multi-Center, Randomized,
Double-Blind, Placebo-Controlled Trial of the
Ex-Vivo Treatment With CGT003 of Peripheral Vein
Grafts in Patients Undergoing Peripheral Arterial
Bypass Graft Procedures.
Sponsor:
Corgentech,
Inc.
Status: Trial completed. Study showed
no effect of gene therapy on graft patency
Summary:
The long-term results of bypasses in the legs,
using the patients' own vein, are limited by
narrowings that develop months to years after
the operation. The purpose of this study is
to test the safety and effectiveness of an experimental
drug in preventing graft narrowing or occlusion
that could result in amputation. The drug is
a form of gene therapy used to treat the patients'
vein during the operation.
Eligible
Patients: Patients who need bypass surgery
of the leg for treatment of critical lack of
circulation.
Trial
Name: REACH: An International Prospective Observational
Registry in Subjects at Risk of Atherothrombotic
Events
Sponsor:
Bristol-Myers
Squibb/ Sanofi Partnership
Status: Closed to enrollment. 58,000
patients enrolled worldwide
Summary:
The purpose of this study is to collect data
on patients with blockages of arteries to the
heart, brain or legs. This epidemiologic study
is intended to provide long term comprehensive
data on risk factors for stroke, heart attack
and peripheral arterial disease.
Eligible
Patients: Patients who have had a heart
attack, stroke or leg circulation problem who
have several risk factors, such as diabetes,
hypertension, high cholesterol or cigarette
smoking.
Trial
Name: Phase II Double-Blind, Randomized, Placebo-Controlled
Study to Assess the Safety and Efficacy of AMG
0001 to improve Perfusion in Critical Leg Ischemia.
Sponsor:
AnGes
Inc.
Status: Enrollment Closed
Summary:
The purpose of this study is to test the safety
and effectiveness of a drug to stimulate new
circulation in the legs of patients with severe
arterial blockages. The drug is a form of gene
therapy, or angiogenesis, which causes new blood
vessels to grow in the legs of patients who
would otherwise be at risk for an amputation.
Eligible
Patients: Patients with critical lack of
circulation in the leg who are not good candidates
for standard bypass surgery. Symptoms caused
by the peripheral arterial disease may be pain
in the foot at night or a nonhealing ulcer or
wound of the foot.
Trial
Name: A comparative Evaluations of Human Thrombin
vs. Bovine Thrombin in achieving hemostasis
in patients undergoing cardiovascular, neurologic
(spine) and general surgery procedures.
Sponsor:
Ethicon
Inc.
Status: Enrollment Closed
Summary:
Thrombin is a liquid that is derived from blood
and is commonly used to help stop bleeding from
small blood vessels or needle holes in arteries
during surgery. The most common source of thrombin
is from cows (bovine). This study is designed
to evaluate the effectiveness of human-derived
thrombin for the same uses during cardiovascular,
spine or general surgery operations.
Eligible
Patients: Patients undergoing any peripheral
vascular operation where thrombin is commonly
used to control intraoperative bleeding, such
as aneurysm repair, leg bypass or dialysis surgery.
Trial
Name: Pivotal Study Protocol: Clinical Study
Comparing Expedial™ and ePTFE Vascular
Access Grafts
Sponsor:
LeMaitre Vascular Inc
Status: Enrolling Patients
Summary:
Patients with end-stage kidney disease are usually
treated with hemodialysis. Dialysis machines
take blood continuously removed from the patient
and filter out toxins before returning the blood
to the circulation. In order to get access to
the patient's circulation a connection is made
between an artery and vein. The best option
is to use the patient's own vein for this connection,
or fistula. However, many patients do not have
veins large enough to use for this purpose.
In this situation, a plastic tube is placed
under the skin to connect the blood vessels
and allow access to the circulation. This study
is designed to compare a new graft that has
desirable properties to the standard PTFE dialysis
graft.
Eligible
Patients: Patients who need placement of
an artificial graft for hemodialysis access.
Phase
2 Gene Transfer Study for Blood Vessel Growth
in Patients with Intermittent Claudication.
Sponsor:
Genzyme
Inc.
Status: Enrollment Closed-Results being
analyzed
Summary:
Intermittent claudication is pain or fatigue
that occurs in muscle groups of the legs due
to peripheral arterial occlusive disease, or
blockage of the leg arteries. Current options
for treatment include angioplasty, which is
frequently not durable, or bypass surgery, with
the risks of an operation. The purpose of this
trial is to investigate the safety and effectiveness
of a novel drug to stimulate the growth of new
arteries of the leg, known as angiogenesis.
Eligible
Patients: Patients with peripheral arterial
disease and intermittent claudication for at
least six months.
