Cordis, a subsidiary of Johnson & Johnson, released the results of its two-year SMART vascular stent clinical trial. The SMART vascular stent clinical trial is designed to test the efficacy of the company’s stent systems in patients diagnosed with obstructive superficial femoral artery disease.
According to a press release by the company, the SMART vascular stent systems are the only devices available on the market that have received FDA indication for the treatment of superficial and iliac femoral artery disease.
The STROLL trial is a multicenter, single-arm, non-randomized trial that compared the efficacy of the SMART vascular stent system against a predetermined goal. According to two-year results from the clinical trial, device efficacy is positive. Approximately 80 percent of patients enrolled in the study met the clinically-driven target revascularization after 24 months.
According to researchers, the two-year patency rate (attributed to the device) was approximately 75 percent, and the primary duplex patency rate was an estimated 83.5 percent.
Cordis reported that patients experienced no adverse events in the 30 days following the surgery (an initial index procedure). In addition, healthcare researchers in the study noted that stent fracture rates were two percent. All stent fractures recorded in the study were Type I, the lowest-risk category.
In its press release, the company noted that the devices have been available on the open market since 1999.