A Medical Device Daily
If at first you don't succeed ... .
Conor (Warren, New Jersey), last year acquired for $1.4 billion by drug-eluting stent (DES) maker Cordis (Miami Lakes, Florida) (Medical Device Daily, Feb. 5, 2007), suffered a major downturn in its developmental prospects last year with the failed-endpoint results of its COSTAR II study.
But it now is taking another stab at DES development.
Yesterday, it reported that it will launch a new trial of a Sirolimus-eluting DES, incorporating a new cobalt chromium reservoir-base stent design, and comparing the stent to the Taxus Liberte Paclitaxel-eluting DES from Boston Scientific (Natick, Massachusetts).
In the COSTAR II trial, Conor CoStar stent failed to achieve non-inferiority for in-stent late loss vs. the Taxus, with the company attributing the failure to the use of "very low doses" of the drug paclitaxel (MDD, May 8, 2007).
At the time, it said it would move to the use of Sirolimus for its next try at DES development, though still using its architecture of tiny reservoirs on the stent as repositories for the eluted drug.
The new trial, dubbed RES-ELUTION, will be a randomized, multi-center comparison of the two stents in de Novo native coronary artery lesions. Primary endpoint of the study is angiographic in-stent late lumen loss at six months. The Conor Stent contains the same drug, sirolimus, as in Cordis' Cypher DES.
Secondary endpoints include target lesion failure, target vessel failure, major adverse cardiac events, stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at six months. Up to 50 patients will also be evaluated via intravascular ultrasound at six months, the company said.
The study will involve 388 patients at 40 sites in Australia, Belgium, Brazil, Denmark, France, Germany, New Zealand, The Netherlands and the UK. Patients will receive clinical follow-up at 30 days, six months and annually through five years.
The company said that trial data will support a CE-mark filing.