Metro Health joins global trial for laser treatment of arterial disease
Metro Health Hospital has announced it is participating in a clinical trial for Spectranetics Corp. related to laser treatment of peripheral arterial disease, or PAD. The trial is expected to involve 353 patients at Metro Health and 34 other teaching hospitals around the world. None of the other hospitals involved so far is in Michigan.
Spectranetics, of Colorado Springs, Colo., sells the only excimer laser system approved in the U.S., Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system.
Called the Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis, or EXCITE ISR, the clinical trial seeks to evaluate the safety and effectiveness of using a laser in combination with balloon angioplasty to open blocked arteries in the legs and feet. EXCITE is the first randomized study evaluating in-stent restenosis.
Patients with PAD often have a stent inserted to permanently open the blocked artery. Stents have been shown to reduce life-threatening complications of PAD; however, after a stent has been implanted, it’s common for patients to develop in-stent restenosis, or ISR, which creates a new blockage in the artery.
The clinical trial will study the differences between using balloon angioplasty alone versus balloon angioplasty in combination with an excimer (or ultraviolet) laser. In balloon angioplasty, a blocked artery is opened by a tiny "balloon" inserted with a catheter. When inflated in the blocked area, the balloon compresses the plaque and other materials blocking the artery, which improves the flow. The balloon is then removed.
The addition of the excimer laser to the process uses ultraviolet light, delivered through a fiber-optic catheter, to vaporize and remove the blockage prior to the balloon being inserted.
“We are incredibly pleased to be the only hospital in Michigan selected for the EXCITE clinical trial,” said Dr. David Duffey, chief medical officer at Metro Health.
PAD can result in limb amputation. Patients at high risk include those who are obese, have diabetes, heart disease or another circulatory issue. Smokers are also at a higher risk, as are African Americans and Native Americans.