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Sansum Clinic Cardiologists Initiate Clinical Trial to Test Bioresorbable Vascular Scaffold for Treatment of Heart Disease

Physicians at Sansum Clinic are currently enrolling patients in the ABSORB III clinical trial. ABSORB III is the first U.S. clinical trial to evaluate the potential benefits of the Absorb Bioresorbable Vascular Scaffold (BVS) in comparison to a medicated metallic heart stent, also called a drug eluting stent, in patients with coronary artery disease, the most common form of heart disease.

The Absorb BVS, made by global health-care company Abbott, is a small mesh tube that is designed to open a blocked heart vessel, restore blood flow to the heart and then dissolve into the blood vessel over time. The scaffold dissolves except for two pairs of tiny metallic markers, which help guide placement and remain in the artery to enable a physician to see where the device was placed.

Sansum Clinic cardiologists Dr. Joseph Aragon (principal investigator) and Dr. Michael Shenoda (sub-investigator) are among the first cardiologists in the Central Coast region enrolling patients into the ABSORB III clinical trial. The trial is being conducted at Santa Barbara Cottage Hospital.

Coronary artery disease is a leading cause of death for men and women in the United States. Patients with this disease can experience symptoms such as chest pain and shortness of breath when the demand for blood to the heart is more than the heart's ability to supply blood due to blockages in the vessels. These blockages are caused by the build-up of fat and cholesterol inside the vessel.

Since the 1970s, physicians have treated coronary artery disease patients with balloon angioplasty and metallic and drug eluting metallic stents, allowing many patients to avoid open heart surgery.

Unlike a metallic stent that remains permanently in the body, Absorb is referred to as a scaffold to indicate that it is a temporary structure. This Absorb BVS is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.

The ABSORB III clinical trial will enroll approximately 2,250 patients, the majority in the United States. The primary endpoint of the trial is target lesion failure, a combined measure of safety and efficacy, at one year compared to standard treatment. In addition, a subset of patients within the trial will be evaluated for novel endpoints such as vasomotion, a measure of how much natural motion returns to the vessel as Absorb dissolves into the arterial tissue.

 Each year, about 785,000 Americans have their first heart attack. Another 470,000 who have already experienced one or more heart attacks will have another. Heart disease accounts for one of every six deaths that take place in the United States.

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