Stentys has announced that it has enrolled the first patient in its APPOSITION IV clinical study using its new Self-Apposing Sirolimus-eluting stent. The randomised study will enrol 150 heart attack patients who will be treated with either the Stentys stent or Medtronic’s Resolute drug-eluting stent, and will compare stent apposition in both groups at four and nine months after treatment.
Conventional drug-eluting stents have shown a high rate of persistent malapposition several months after heart attack treatment. This malapposition can trigger stent re-clotting, recurrence of the heart attack and possible subsequent death years afterwards.
“Long-term malapposition of drug-eluting stents has been associated with late stent thrombosis, so this randomised trial with the new Stentys Sirolimus-eluting self-apposing stent will be carefully followed by the community,” said William Wijns, co-principal investigator of the study and chairman of EuroPCR.
“Following the excellent results from the APPOSITION III study, we are going to add the Sirolimus-eluting stent to our portfolio and combine the beststent platform with a proven drug from the ‘limus’ family,” said Gonzague Issenmann, CEO and co-founder of STENTYS. “Cardiologists will have access to Stentys stents eluting the two compound families available on the market.”
The trial enrolment is expected to be completed before the end of 2012, and the final results to be announced in the second half of 2013. The Sirolimus-eluting Stentys stent CE mark is expected in the second half of 2014.