Trial assessing plaque excision device begins

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The first patient has been enrolled in the SWIFT clinical trial, a non-randomized, multi-center study assessing the long-term outcomes for patients with peripheral arterial disease (PAD) treated with the SilverHawk Plaque Excision System (FoxHollow Technologies). After treatment with plaque excision, 100 patients will be followed for a year using duplex ultrasound, and in some cases, also will be evaluated using CT angiography.

The first SWIFT patient was treated by Dr Jeffrey Martinez, a vascular surgeon at Baptist Medical Center in San Antonio, TX. Data collected by these sites will be submitted to two independent third party core labs for review. University of Washington Medical Center will handle the duplex ultrasound analysis. Quantitative vascular angiographic assessment will be directed by Dr Jeff Popma, an interventional cardiologist at Brigham and Women’s Hospital in Boston, MA.

“With over 800 patients enrolled, the TALON study showed us that plaque excision was an effective method of treatment for patients with significant blockages in the arteries above and below the knee,” said Dr James McKinsey, Site Chief of Vascular Surgery at Columbia University of the Columbia/Weil Cornell Division of Vascular Surgery, and principal investigator of SWIFT. “The SWIFT study is designed to provide definitive objective data confirming the high clinical success, durability and safety that was demonstrated with plaque excision in the initial TALON registry.”

FoxHollow Technologies also announced a new randomized, controlled, multi-center study is set to begin later this year. The PROOF study will compare SilverHawk to open surgical bypass for patients who are at extremely high risk for limb loss due to critical limb ischemia (CLI). Patient enrolment in the new PROOF study is expected to begin by the end of this year. The study will randomize 400 patients with CLI either to SilverHawk or surgical bypass. The primary study endpoint is amputation-free survival. The study will also measure ten additional endpoints such as limb salvage, quality of life, re-intervention rates and the cost efficiency of each procedure. Patients will be followed for five years post-procedure with interim outcomes analysis to be reported initially at six months and one year.

“Bypass surgery is still considered the standard of care, despite the fact that this approach is a very invasive one that typically requires long recuperation periods and may be associated with perioperative complications given that these patients often have many coexisting illnesses,” said Dr David Kandzari, interventional cardiologist at Duke University Medical Center and the Duke Clinical Research Institute, and co-principal investigator on the PROOF study.

“We know from clinical practice that minimally invasive alternatives such as plaque excision provide exceedingly good outcomes for patients with short recovery times. We expect this study to provide compelling evidence that an endovascular option such as plaque excision is an excellent alternative to bypass surgery with beneficial impacts on safety, efficacy, quality of life and cost.”

In addition to these two new trials, FoxHollow is supporting a number of studies related to its expanding biologics programme. The largest of these studies is LEAP, a large, multi-center, multi-arm trial involving patients who have arterial blockages in both legs. Over 60 hospitals in the US are participating.

Patients enrolled in LEAP will undergo plaque excision in one leg, receive one of three study drugs or a placebo for a period of time, and then undergo plaque excision in the other leg. Plaque samples from both legs will be analysed to uncover gene and protein differences that might lead to the discovery of new biomarkers for atherosclerotic disease, and potentially provide an effective tool to accelerate drug development. The identification of novel biomarkers may someday enable physicians to understand and treat each patient’s vascular disease on the basis of the individual’s unique biological profile.