Coronary Artery Disease Clinical Trial
Official title:
Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigation
Objective of this First in Man study is to assess feasibility and safety of Qvanteq's
bioactive coronary stent for treatment of stable coronary artery disease patients with de
novo coronary artery stenosis in native vessels.
The proprietary surface of Qvanteq's bioactive coronary stent improves the in-growth
behavior of the stent in the treated vessel. In-vivo animal studies revealed fast in-growth
(similar to BMS), which however is not resulting in excessive tissue overgrowth as observed
in BMS but rather has an efficacy profile similar to drug-eluting stent (DES), meaning
suppression of tissue overgrowth. This should reduce the risk of restenosis and thrombus
formation despite the presence of a short term dual anti platelet therapy (DAPT).
Furthermore, prolonged DAPT time as applied with current DES increases the bleeding risk of
patients.
The study is a prospective, multicenter, open-label, single arm study; conducted in up to 6
cardiology centers in CH and NL. In total, approx. 35 patients will be enrolled. All
patients will be treated with the Qvanteq's bioactive coronary stent. Clinical follow-up
will occur at 1, 6 & 12 months post-stent implantation. All patients will undergo
angiography assessment (QCA) and Optical Coherence Tomography investigation (OCT) at
baseline and at 6 months follow-up. Baseline OCT should be performed after the successfully
completed angiographic procedure (documentary OCT). 1 and 12 months clinical follow-ups are
conducted via telephone.
Primary Angiographic endpoint is in-stent Late Lumen Loss at 6 months; assessed by off-line
QCA. Primary OCT endpoint is mean neointimal thickness at 6 months; assessed by off-line OCT
analysis.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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