| February 16, 2005
The Hospital of the University
of Pennsylvania Begins Clinical Trial of Newest Technology
to Treat
Thoracic Aortic Aneurysms
(Philadelphia, PA) – A clinical trial is underway
at the Hospital of the University of Pennsylvania
(HUP) to study the safety and effectiveness
of an endovascular medical device to treat life-threatening
thoracic aortic aneurysms. Ronald Fairman, MD,
Chief of Vascular Surgery at HUP, is leading the study
at Penn and is one of 35 principal investigators in
North America to participate in this landmark trial.
Thoracic aortic aneurysms (TAAs) occur when a section
of the aorta – the body’s largest artery
that carries blood out of the heart and into the organs
of the body – weakens and bulges outward like
a balloon in the section of the artery that runs down
the chest.
Each year, more than 20,000 patients in the United States
are diagnosed with TAA. Aortic aneurysms – including
thoracic and abdominal aortic aneurysms – remain
the 13th major cause
of death in this country, accounting for nearly 15,000
deaths annually.
“The STARZ-TX2 trial is groundbreaking and excellent
news for patients diagnosed with descending thoracic
aortic aneurysms,” says Dr. Fairman. “Surgery
can be life-threatening for many of these patients and
a ‘wait-and-see’ approach is often not an
option because patients are at an increased risk of
an aortic rupture. A non-surgical approach to treating
this life-threatening disease could benefit thousands
of lives.”
The clinical trial, called STARZ-TX2 (Study of Thoracic
Aortic Aneurysm Repair with the Zenith®
TX2™ Thoracic TAA Endovascular
Graft), is open to patients diagnosed with a descending
thoracic aortic aneurysm. STARZ-TX2 will compare the
outcomes of patients treated with open surgery to patients
treated with the Zenith TX2 Thoracic TAA Endovascular
Graft, manufactured by Cook Incorporated. Specifically,
the trial will assess device performance, as well as
patient survival and aneurysm rupture rates in the surgical
and endovascular treatment groups, over a 12-month period.
The trial will enroll 275 patients at up to 35 medical
institutions in the United States and Canada. Additional
trial sites in Japan, Australia and Europe also will
participate.
Currently, surgical repair is the standard of care for
the treatment of TAAs. Surgical repair requires a surgeon
to open the chest cavity, clamp off the aorta and sew
a surgical graft in place to prevent an aneurysm from
rupturing. Open surgical repairs carry high health risks
for many older patients, who may also suffer from other
significant medical conditions such as heart disease,
lung disease, diabetes or hypertension.
The Zenith TX2 system requires an incision to insert
the graft’s hydrophilic, kink-resistant delivery
system into the femoral artery in the leg. Once the
system is guided into position through the patient’s
arteries under fluoroscopy, a one- or two-piece, fabric-covered,
self-expanding stent graft is placed inside the weakened
section of the thoracic aorta to relieve pressure on
the aneurysm, helping to reduce the risk of rupture.
Endovascular treatment of aortic aneurysms has been
a common practice for the past 10 years in the United
States, Europe and Asia. During that time, significant
improvements in treatment outcomes have been observed
among patients treated with endovascular devices as
compared with standard open surgery. Current endovascular
treatments are marketed worldwide for the treatment
of abdominal aortic aneurysms.
The major cause of thoracic aortic aneurysms is a hardening
of the arteries, a condition in which fatty deposits
adhere to the walls of the arteries, which become less
elastic and weaker as a result. Major risk factors leading
to a hardening of the arteries include smoking and high
blood pressure as well as genetics. Other possible causes
of TAA include trauma to the aorta and congenital diseases
such as Marfan’s syndrome.
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###
PENN Medicine is a $2.7 billion
enterprise dedicated to the related missions of medical
education, biomedical research, and high-quality patient
care. PENN Medicine consists of the University of Pennsylvania
School of Medicine (founded in 1765 as the nation’s
first medical school) and the University of Pennsylvania
Health System (created in 1993 as the nation’s
first integrated academic health system).
Penn’s School of Medicine is ranked #3 in the
nation for receipt of NIH research funds; and ranked
#4 in the nation in U.S. News & World Report’s
most recent ranking of top research-oriented medical
schools. Supporting 1,400 fulltime faculty and 700 students,
the School of Medicine is recognized worldwide for its
superior education and training of the next generation
of physician-scientists and leaders of academic medicine.
Penn Health System is comprised of: its flagship hospital,
the Hospital of the University of Pennsylvania, consistently
rated one of the nation’s “Honor Roll”
hospitals by U.S. News & World Report; Pennsylvania
Hospital, the nation's first hospital; Presbyterian
Medical Center; a faculty practice plan; a primary-care
provider network; two multispecialty satellite facilities;
and home health care and hospice.
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