Clinical Research News
Advancing Treatment of Vascular Diseases
Peripheral arterial disease (PAD)
Cholesterol or scar tissue build up in the arteries of the legs, causing them to narrow.
Courtesy of Cook®Surgical techniques for treating major vascular diseases are rapidly evolving, becoming safer, and becoming available to more patients.
What makes such advances possible is rigorous research to define which situations demand open or minimally invasive techniques;
to examine public health issues such as cost, length of stay, and screening; and to monitor surgical techniques for complication rate, safety, and efficacy.
As a leading institution in the quest to refine and advance open and minimally invasive procedures for major vascular disorders, NewYork-Presbyterian Hospital is currently conducting 16 clinical trials.
Trials of open procedures include techniques to treat carotid stenosis, stroke, peripheral vascular arterial insufficiency, and aortic aneurysms.
Minimally invasive procedures under study include those for carotid stenosis, peripheral vascular occlusive disease and abdominal and thoracoabdominal aneurysms.
"The hope is that we will identify patients who need treatment earlier and be able to intervene more effectively, with the proper individualized procedures and with less complication and cost," explains Roman Nowygrod, MD, Professor of Surgery and Director of the Vein Disorder Treatment Center at the Department of Surgery, Columbia University College of Physicians and Surgeons.
For the treatment of carotid stenosis, studies at NewYork-Presbyterian Hospital are comparing open carotid endarterectomy with minimally invasive balloon angioplasty procedures.
For the treatment of aneurysms, researchers are investigating both FDA approved and new endovascular stent grafts, and, in parallel, evaluating the outcomes and cost of endovascular repair compared to open repair of aneurysms.
Another clinical investigation focuses on embolization, or the dislodgement of clots, during balloon angioplasty in the leg.
Trials being conducted in conjunction with the International Center for Health Outcomes and Innovation Research (InCHOIR) are evaluating the safety of new minimal access treatments for vascular disorders.
In these investigations, researchers in the Division of Vascular Surgery are examining trends during the last 20 years that have changed patterns of treatment, mortality, and complication rates.
Examples of their findings include the following:
- Aneurysm surgery—today almost half of patients with abdominal aortic aneurysms nationwide are treated with minimally invasive endovascular surgery, compared to just ten years ago when nearly all patients had open surgery to treat these conditions.
At NewYork-Presbyterian Hospital, about 80% of patients are now treated with endovascular methods, with mortality and complication rates significantly lower than the traditional surgical approaches.
- Carotid stenosis and lower extremity arterial occlusive diseases have undergone similar trends: high-risk patients are now often treated with balloon angioplasty and stent procedures, whereas even five years ago, they would have had open surgery.
The ZILVER® stent is the first paclitaxel-coated stent to be tested for treatment of peripheral arterial disease.
Physicians insert the stent through a tiny hole in the groin and advance it through a catheter to the narrowed segment of the artery.
After the stent is deployed, it expands and keeps the artery open indefinitely.
The addition of paclitaxel may help to prevent restenosis, or recurrent narrowing of the artery.
Their findings of safety and efficacy are leading to widespread changes in practice throughout the nation.
"These studies are already having an impact at the national level in formulating public policy regarding screening," says K. Craig Kent, MD, Chief, Division of Vascular Surgery, NewYork-Presbyterian Hospital.
"For example, this year, the federal government is approving cost reimbursement for screening for abdominal aneurysms for patients at high risk."
The ZILVER® trial provides an example of how NewYork-Presbyterian Hospital trials are extending the use of a valuable technique to treat new areas of the body.
This clinical trial is investigating the first paclitaxelcoated stent for arteries in the legs.
While drug-coated stents have been proven to prevent restenosis (narrowing) of the arteries of the heart, this is the first stent to be tested in the leg.
"Preliminary results suggest that there are differences between the leg and coronary arteries, so the stent must be studied in the leg.
Ours is the only study in the U.S. to investigate this," states Nicholas J. Morrissey, MD, Bicampus Director of Clinical Trials, Assistant Professor of Surgery at Columbia University College of Physicians and Surgeons/Weill Cornell Medical College, and Principal Investigator of this multi-center trial.
NewYork-Presbyterian Hospital is the leading institution among approximately 20 participating in the ZILVER® study.
Dr.Morrissey acknowledges that conducting research at two university campuses presents unique challenges—especially in navigating through double the required regulatory processes.
He is enthusiastic about the strength of the vascular program, however. "Our faculty are recognized as world leaders in vascular intervention.
As a result, NewYork-Presbyterian is chosen for many of the most cutting-edge trials in the world," he explains.
"Even if patients may not be eligible for a particular study, they can be assured that our doctors are top in their field."
To learn more about clinical trials in the Division of Vascular Surgery, please click here or call 201.346.7001.
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