Svelte Medical Systems has announced treatment of the first patient in its DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) study at Middelheim Hospital in Antwerp, Belgium.
According to a company press release, DIRECT II is a prospective, randomised, multicentre clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to Medtronic’s Resolute Integrity drug-eluting stent. The press release added that study builds on the positive six-month results of the DIRECT I first-in-man study which evaluated the Svelte drug-eluting coronary stent IDS in 30 patients in New Zealand. In DIRECT I, the Svelte drug-eluting coronary stent IDS met all study endpoints and demonstrated in-stent neointimal volume obstruction of 2.7% as assessed by intravascular ultrasound (IVUS), which is one-third to one-half the volumetric obstruction observed in market-leading drug-eluting stent first-in-man studies.
The Svelte drug-eluting coronary stent IDS combines a thin-strut cobalt chromium stent with a fully bioabsorbable drug carrier made of amino acids, which are also found naturally in the human body, and the well-studied compound sirolimus (rapamycin) mounted on a fixed-wire delivery system. Low profile and highly flexible, the Svelte IDS navigates the vasculature similar to a traditional guidewire, facilitating use of the transradial approach and general downsizing of the access site, while allowing access to more difficult to cross and distal lesions. The system also includes proprietary Balloon Control Band (BCB) technology providing uniform and controlled balloon growth, even at high pressures, to safely perform direct stenting as well as high-pressure post-dilatation, thereby minimising procedure time and cost.
“The Svelte IDS offers a unique approach to percutaneous coronary intervention and we look forward to evaluating the performance of the drug-eluting platform in this highly scientific clinical study,” said Stefan Verheye, co-director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp. “We have experience with the bare-metal version of the IDS, and the system’s low profile and unique balloon technology have allowed us to direct stent both simple and complex lesions.”
The DIRECT II study will enrol 159 patients at up to 20 clinical sites in Europe and Brazil to assess the primary endpoints of Target Vessel Failure (TVF) and in-stent Late Loss (LL). All patients are scheduled to receive 6-month clinical and angiographic follow-up, with clinical follow-up through five-years. A subset of patients will also receive optical coherence tomography (OCT) imaging at six-months.