Spectrum Health Leading Enroller in International Trial to Improve Abdominal Aortic Aneurysm Repair
Clinical Study Evaluates Safety and Efficacy of Aneurysm Sealing System for Endovascular Repair
Spectrum Health is the leading enroller in an international clinical trial for a new investigational device designed for the repair of some abdominal aortic aneurysms (AAA).
The trial, which recently closed to enrollment, is designed to determine if a new stent graft procedure that seals the AAA repair in a polymer will result in reduced leaks and surgical repairs. The trial enrolled 179 patients at 29 centers in the U.S. and Europe. Spectrum Health physicians performed the procedure on 19 patients.
Spectrum Health Medical Group vascular surgeon Robert Cuff, MD, who leads the trial at the Fred and Lena Meijer Heart Center, attributes that level of participation to Spectrum Health’s ongoing efforts to identify surgical candidates through screening.
“The dedication and teamwork of our vascular surgeons working with their staff allowed us to identify a sizeable number of candidates for this trial,” Cuff said.
The aorta is the body’s main artery, carrying blood from the heart to the rest of the body. An AAA is an enlarged and weakened section, or “ballooning” of the aorta that is prone to rupture and often times death. According to the Centers for Disease Control, approximately 13,000 Americans die each year from thoracic and abdominal aortic aneurysms. Most of the deaths result from rupture or dissection, a kind of splitting of the aorta.
The trial, EVAS FORWARD, sponsored by Endologix, Inc., evaluates the safety and efficacy of the Nellix™ EndoVascular Aneurysm Sealing System (EVAS). The device is not commercially available in the United States, and is only available at selected clinical study sites for investigational use. It is only for infrarenal AAAs, which occur below the renal arteries, the blood vessels that lead to the kidneys.
“In the cases performed at our site, we found the Nellix procedure to be simple, predictable and with good acute outcomes. Based upon our results so far, we expect that Nellix will significantly reduce endoleaks and provide meaningful clinical benefits for patients. We look forward to participating in the Continued Access phase of the IDE and offering Nellix to patients when it is commercially available in the U.S,” Cuff said.
There are two approaches to the repair of AAAs. The standard procedure is called an open repair where a patient’s abdomen is surgically opened to gain access to the aneurysm.
A more recent procedure is the endovascular aneurysm repair, which is a minimally-invasive procedure. A doctor makes a small incision in each groin to access the femoral arteries. A stent-graft is then inserted through one or both of the femoral arteries and advanced up into the aorta to the site of the aneurysm.
A stent-graft is a long cylinder-like tube made of a thin metal stent frame covered with a graft material such as polyester. The stent helps to hold the graft in place. The stent-graft is inserted into the aorta and placed at the site. Once in place, the stent-graft is expanded, attaching to the wall of the aorta and supporting it. The aneurysm eventually shrinks down onto the stent. Most times two or more stent pieces are combined to repair the aneurysm.
There are two common complications with this procedure, said Cuff. One is blood from small vessels leaking back into the aneurysm sac, the space created between the stent and the damaged aorta. The other complication is shifting of the stent-graft which can cause the pieces to separate. This can cause the stent-graft to leak, requiring a surgical repair. These complications can occur in up to 20 percent of cases and require additional surgeries to repair.
“This Nellix system includes an additional step in performing a minimally-invasive AAA repair,” said Cuff. “Once the stents are in place, special endobags surrounding the stents are filled with a resin-like polymer material that fills the remaining aneurysm sac to protect the aorta while excluding and sealing the aneurysm from blood flow. By sealing the aneurysm sac, we hope to learn if this will significantly reduce these complication rates.”
The EVAS FORWARD-IDE clinical trial enrolled 179 patients at 29 centers in the U.S. and Europe. Enrollment under an extended investigation phase is anticipated to begin shortly and will continue during the pivotal trial follow-up period and PMA preparation/review process. Based on current assumptions and timelines, the company anticipates FDA approval of the Nellix System in the U.S. before the end of 2016.
Additional information about Nellix and the trial can be found at www.endologix.com.
Spectrum Health is a not-for-profit health system, based in West Michigan, offering a full continuum of care through the Spectrum Health Hospital Group, which is comprised of 11 hospitals including Helen DeVos Children’s Hospital; 170 ambulatory and service sites; 1,150 employed physicians and advanced practice providers including members of the Spectrum Health Medical Group; and Priority Health, a 590,000-member health plan. Spectrum Health is West Michigan’s largest employer with 21,400 employees. The organization provided $294,625 million in community benefit during its 2014 fiscal year. In 2014, Spectrum Health was named one of the nation’s 15 Top Health Systems® by Truven Health Analytics.