UPMC Heart and Vascular Institute Recruiting Patients for Nectero Medical StAAAble Clinical Trial Investigating Novel Therapeutic for Small to Mid-Size Abdominal Aortic Aneurysms

The UPMC Heart and Vascular Institute is participating in an international, multicenter phase 2/3 randomized controlled clinical trial sponsored by Nectero Medical evaluating the Nectero EAST^® system for treating abdominal aortic aneurysms (AAA).

Vascular surgeon Raymond E. Eid, MD, is the principal investigator at the UPMC study site. Dr. Eid’s focus is on treating aneurysms, carotid disease, and peripheral vascular disease using open and endovascular techniques.

Study Details

The study, “Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy (stAAAble),” is designed to treat patients with small to mid-sized AAAs with maximum diameters of 3.5 to 5 cm using an endovascularly delivered investigational therapeutic with the potential to slow aneurysm growth, and possibly reduce the risk of a catastrophic rupture.

Patients enrolled in the study will be evaluated post-procedure at regular intervals for up to five years to monitor for treatment efficacy as measured by stability of the patient’s AAA on CT scans.

“This AAA patient population historically has been without any treatment options,” Dr. Eid explains. “Current guidelines typically recommend surveillance without intervention until aneurysms reach 5.5 cm in diameter (or 5 cm in women), the current threshold for surgical repair. As a result, many patients are monitored for years while the aneurysm continues to enlarge and the disease progresses.”

About the Nectero EAST System

The Nectero EAST system is an investigational, one-time treatment using a therapeutic that targets a specific protein in the tissue of the abdominal aortic wall that weakens over time leading to aneurysm growth. The Nectero EAST system uses a catheter-based dual balloon approach to deliver the therapeutic. The first balloon is inserted below the renal arteries to occlude the aneurysm, while the second balloon is then inserted and expanded in the AAA to deliver the therapeutic directly into the wall of the aorta.

The entire procedure takes approximately one hour. The Nectero EAST system does not involve permanent implants in the patient, and the approach does not foreclose on any future interventions the patient may need to deal with their aneurysm should it continue to grow or otherwise change over time.

“With AAA’s in the size range being treated in this clinical trial, the one-year risk of a rupture ranges from 0.5 to 5%, and we know the risk increases significantly as the aneurysm enlarges,” Dr. Eid says. “If the Nectero EAST treatment approach can prevent these aneurysms from growing, while also strengthening the existing tissue, we can theoretically mitigate the risk of rupture. This would also allow us to delay – and potentially avoid – the need for repair in the future. We’re excited to offer this study to patients at UPMC and contribute to the development of a promising potential treatment option for this group of patients.”

Patient Referrals and Contact Information

To learn more about the study or to refer a patient to UPMC for possible enrollment, please email study coordinator, Judith Brimmeier, at brimmeierja@upmc.edu.