While experts are debating the safety of drug-eluting stents in patients with stable coronary heart disease (see page 1, this issue), the first patient has been enrolled in the Xpert Nitinol Stenting for Critically IschEmic Lower Limbs (XCELL) trial, the initial US study to evaluate the safety and efficacy of the Xpert self-expanding stent in blood vessels below the knee for the treatment of patients with severe peripheral arterial disease (PAD).
The patient, who has just received the Xpert stent is an 87-year-old man with PAD who has leg pain at rest and gangrenous ulcers on his left foot as well as other health problems, including diabetes. Before the procedure, the arteries in his left calf were completely blocked.
The procedure was successful in opening the most critical blockage below his knee and restoring blood flow to his foot. The patient was discharged from the hospital with no complaints of pain on the morning after the procedure. He is expected to return for follow-up exams at 1, 3, 6, and 12 months to monitor his condition and the stent function.
“Those with advanced disease may be poor candidates for surgery and have few treatment options, making many of them at high risk for losing a limb,” said lead investigator James Joye, DO, of El Camino Hospital, Mountain View, Calif.
A total of 10 healthcare centers have signed up to participate in the XCELL study, which is expected to enroll 140 patients. The primary end point is the incidence of major amputation at 12 months after treatment.