Successful Enrollment of First Five Patients in a New Study Combining Existing Therapeutic Techniques
Dr. Christopher Owens, a vascular surgeon at the University of California, San Francisco (UCSF) and the San Francisco Veterans Affairs Medical Center (SFVAMC), has reached an important milestone by enrolling five patients in a breakthrough study aimed at reducing re-narrowing following treatment of blockages of the leg arteries.
Peripheral artery disease (PAD) affects 10-12 million Americans and is a significant source of pain and disability. PAD is caused by a chronic buildup of fatty plaque within the arterial wall and restricts blood flow to the legs and feet. This can result in pain in the legs, non-healing ulcers in the feet and amputations in the worst cases. Many of these patients can be treated by minimally invasive surgery to open arteries with restricted blood flow or blockage. Although the minimally invasive techniques such as balloon angioplasty or stenting of the artery allow a patient to avoid surgery, they often lead to the buildup of thick scar tissue that can re-narrow the artery in as many as 50-70% of treated patients in only one year. In his innovative study, Dr. Owens has adopted a new minimally invasive technique to deliver an anti-inflammatory drug to prevent scar tissue buildup after restoring blood flow.
This study at UCSF and SFVAMC integrates a medical device and drug that have each been FDA approved. The device - the Bullfrog® Micro-Infusion Catheter from Mercator MedSystems in San Leandro, Calif. - can precisely deliver drugs into the inflamed tissues (the adventitia and perivascular tissues) that surround diseased and damaged arteries. The catheter is threaded into the artery and navigated to the treatment site, where a tiny microneedle is deployed. The drug is injected into the tissues surrounding the artery and bathes the artery with the drug. Dr Owens reports that, "this is a very efficient way to deliver the drug right where it is needed to treat the artery and avoid any toxic side effects." This device has been used in other clinical applications in the United States, but this is the first time that it has been used in diseased peripheral arteries.
In this study, Dr. Owens is using the device to inject the anti-inflammatory steroid dexamethasone. Dexamethasone is typically used to treat allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, breathing disorders, asthma, allergies, and arthritis. Dr. Owens continues, "This technique of diffusing dexamethasone around arteries should reduce procedural inflammation and lead to more sustained blood flow in the leg so that the patient does not have to return as soon for another procedure to re-open the arteries. We're excited to continue with the study and follow the patients to see if this procedure has a lasting effect in the treatment of PAD."