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  • 201-833-3000

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  • 877-HOLY-NAME (465-9626)

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  • 201-833-3300

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Clinical Research

Advanced Clinical Trials to Prevent Lower Leg Amputation

SAVAL – Drug coated stent for below-knee arterial blockages

TOBA – Tack Optimized Balloon Angioplasty Study

Nearly 17 million people in the U.S. live with peripheral arterial disease (PAD), leading to thousands of individuals needing limb amputations. Now eligible patients with PAD may have access to highly successful procedures through national and international clinical trials at the Interventional Institute at Holy Name Medical Center.

The treatments are "revolutionizing" the care people can receive for blocked blood vessels in their legs, according to Dr. John Rundback, Director of the Institute and one of the investigators in the trial. The two studies, Tack Optimized Balloon Angioplasty (TOBA) and BTK Vascular Stent System (SAVAL), offer treatments for ongoing issues that can arise from treating blocked vessels in the legs.

Standard care for patients with PAD often involves a balloon angioplasty – a procedure that uses a tiny balloon to hold open the artery or vein while a mesh stent is implanted. The stent is designed to keep the walls of the vessel open permanently. Many times, however, complications arise – other blockages develop, the stent can trigger inflammation and scar tissue may form.

Both the TOBA and SAVAL trials provide advanced technology to help prevent these complications. In the TOBA study, small tacks are inserted to repair tears in the treated artery, vastly decreasing the chance of inflammation and another blockage forming. The SAVAL trial is evaluating the initial and long-term effectiveness of stents coated with a medication that interacts with the surrounding muscle to prevent scar tissue buildup, which may create more clogs in the small arteries of the lower leg.

"Ten years ago about 50 percent of patients with PAD had a recurrence after angioplasty," Dr. Rundback said. "These new technologies are completely changing the way we treat patients with complex blockages in their lower legs that lead to amputation, and reduce the need for repeat procedures dramatically – it's amazing."

Early results of the TOBA study indicate more than 90 percent of patients have experienced restored blood flow to the affected area. This enhanced blood flow promotes healing, improves outcomes and preserves limbs. Data from the SAVAL trial are not yet available.

Not all patients qualify to participate in the TOBA or SAVAL studies. A patient's medical history and the type and size of blockages are reviewed to determine eligibility. For more information, call the Interventional Radiology department at 201-227-6210.

Holy Name offers numerous clinical inpatient and outpatient studies for individuals with all types of diseases and conditions. High quality clinical trials are conducted at the Medical Center to test new medications, devices, diagnostic modalities and treatment protocols. Call Holy Name's Institute of Clinical Research at 201-541-6312 or go to for more information.

For information on these clinical trials and others approved by the federal government, visit