Metro Health Hospital Participates in PAD Research
Metro Health Hospital is the first – and only – hospital in Michigan participating in a new clinical trial for a treatment related to peripheral arterial disease, or PAD.
The Metro Health Heart & Vascular team recently enrolled its first patient in the clinical trials conducted by Spectranetics Corporation, Colorado Springs, CO. The study, Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis, or EXCITE ISR, seeks to evaluate the safety and efficacy 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 suffering from PAD often have a stent inserted to permanently open the blocked artery. Stents have been shown to reduce the frequency of life-threatening complications of PAD and improve clinical outcomes. After a stent has been implanted, it’s common for patients to develop in-stent restenosis, or ISR, which creates blockage in the artery.
The clinical trial will evaluate the differences between using balloon angioplasty alone versus balloon angioplasty in combination with an Excimer laser. Balloon angioplasty is the process of opening a blocked artery with 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 utilizes an 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. “We are able to participate in cutting-edge research like this clinical study due to the team approach we take at Metro Health in the treatment of complex PAD and critical limb disorders. Each physician at Metro Heart & Vascular plays an integral role to support the international level of work being done here.”
The study is expected to enroll 353 patients at Metro Health and 34 other teaching hospitals around the world. These patients will be followed for outcomes for one year.
PAD can be a devastating diagnosis for patients, resulting 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.