Swiss coronary stent company Qvanteq enrolled first patient in clinical study25.11.2014 10:02
Qvanteq AG today announced that it has enrolled the first patient in the First in Man (FiM) clinical study QUEST I, this is following earlier regulatory approval from the Dutch and Swiss authorities. The aim of the QUEST I study is to assess feasibility and safety of the Qstent, a bioactive, coating-free coronary stent. The Qstent has shown excellent in-growth and a low tendency to produce a thrombus or clot in pre-clinical studies.
“Enrolling the first patient is a significant step towards clinical proof of concept for our bioactive and coating-free coronary stent”, commented Qvanteq’s CEO and founder Arik Zucker. “It is also the result of several years of strong commitment to bringing our technology to patients”, he added.
“This unique stent concept is indeed very exciting because there is no drug coating and therefore, it might well present clear benefits for the treated patients in terms of minimum dual antiplatelet treatment time. Fast endothelialization accompanied by low restenotic and low thrombogenicity potential offers patients a very valuable alternative to currently used stents in the clinic”, says Prof. Patrick W. J. C. Serruys, Chairman of QUEST I at Erasmus University, Thoraxcentrum, Rotterdam, NL.
Earlier in the year, Qvanteq AG obtained the ISO 13485 certification.
Qvanteq AG develops novel bioactive, coating-free stents to address and overcome the clinically adverse effects of today’s available stents. Qvanteq AG was founded in early 2009 and is held by private investors. Qvanteq is ISO 13485 certified. The company is based at the Technopark in Zurich, Switzerland.
About the Qstent
The Qstent is a novel and unique alternative to available coronary stents. It draws its neointimal suppression and low thrombogenicity entirely from its surface properties without the need of coatings or eluting drugs. Neointimal suppression in combination with minimum time of dual anti-platelet treatment (DAPT) are in great demand and the Qstent might therefore offer advantages in the treatment of coronary artery disease patients.
The Qstent bioactive surface is ultra-hydrophilic and its unique surface selectively interacts with the blood: immediately upon introduction into the blood stream, Qstent’s bioactive surface selectively recruits anti-thrombogenic and neointimal suppressive factors from the blood, leading to an optimal integration of the stent into the vessel wall.
Qvanteq’s novel bioactive, coating-free surface technology is simple and cost effective and the surface of any stent can be modified accordingly.
About QUEST I
Objective of this First in Man clinical study is to assess feasibility and safety of Qvanteq’s bioactive, coating-free coronary stent for treatment of stable coronary artery disease patients with de novo coronary artery stenosis. The study is a prospective, multicenter, open-label, single arm study; conducted in 4 cardiology centers in Switzerland and 2 in the Netherlands. In total, 35 patients will be enrolled. All patients will be treated with the Qstent, Qvanteq’s bioactive coronary stent. Clinical follow-up is scheduled at 1, 6 & 12 months post-stent implantation. All patients will undergo angiography assessment (QCA) and high resolution intracoronary imaging using Optical Coherence Tomography investigation (OCT) at baseline and at 6 months follow-up. This will offer unique insights in the arterial healing profile of the Qstent. Primary Angiographic endpoint is in-stent Late Lumen Loss at 6 months; assessed by QCA. Primary OCT endpoint is mean neointimal thickness at 6 months; assessed by OCT analysis.