This balloon expandable stent is combined with a guide 0.014 in its distal part. The platform is made of cobalt chrome and the polymer is bio-degradable. 30 patients were included prospectively and there was angiographic follow-up with IVUS and OCT after 6 months. The reference vessel diameter was 2.69 mm ± 0.48, with a length of 11.72mm ± 3.99.
The success of the device was of 97% and of 100% for the procedure. At the 6 and 12-month follow-up, there were no clinically guided deaths, myocardial infarctions or revascularizations, but there was one revascularization due to angiographic restenosis.
Conclusion: This new delivery system that integrates the stent and the guide is an attractive alternative for cases where direct stenting is planned.
mark_webster_europcr
Mark Webster
2013-05-22
Original title: Final 6-month results of the DIRECT (Direct-on-a-wire implantation of Rapamicyn-eluting stent with bioabsorbable Carrier Technology) first-in-man study.