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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
PCI
Thoraxcentrum Twente, Medisch Spectrum Twente
Enschede, Netherlands
Thoraxcenter Erasmus MC Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands
Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern
Bern, Switzerland
Cardiologie interventionnelle HUG - Hôpitaux Universitaires de Genève
Geneva, Switzerland
HerzKlinik Hirslanden
Zurich, Switzerland
Stadtspital Triemli Zürich Klinik für Kardiologie
Zurich, Switzerland
In-stent Late Lumen Loss (LLL) assessed by off-line QCA
Time frame: At 6 months after stent implantation
Mean neointimal thickness assessed by off-line OCT analysis
Time frame: At 6 months after stent implantation
Acute lumen gain assessed by off-line QCA
Time frame: At 6 months after stent implantation
In-segment Late Lumen Loss assessed by off-line QCA
Time frame: At 6 months after stent implantation
Mean Lumen Diameter (MLD) assessed by off-line QCA
Time frame: At 6 months after stent implantation
Diameter stenosis assessed by off-line QCA
Time frame: At 6 months after stent implantation
Binary restenosis (diameter stenosis > = 50%) assessed by off-line QCA
Time frame: At 6 months after stent implantation
Prolapse area/volume assessed by off-line OCT analysis
Time frame: At baseline
Mean/minimal lumen diameter/area/volume assessed by off-line OCT analysis
Time frame: At baseline and at 6 months after stent implantation
Mean/minimal stent diameter/area/volume assessed by off-line OCT analysis
Time frame: At baseline and at 6 months after stent implantation
Stent symmetry assessed by off-line OCT analysis
Time frame: At baseline and at 6 months after stent implantation
Stent expansion assessed by off-line OCT analysis
Time frame: At baseline and at 6 months after stent implantation
Incomplete strut apposition assessed by off-line OCT analysis
Time frame: At baseline and at 6 months after stent implantation
In-stent neointimal hyperplasia volume obstruction (%) assessed by off-line OCT analysis
Time frame: At 6 months after stent implantation
Neointimal hyperplasia area/volume assessed by off-line OCT analysis
Time frame: At 6 months after stent implantation
Mean/maximal thickness of the struts coverage assessed by off-line OCT analysis
Time frame: At 6 months after stent implantation
Percentage number of covered struts assessed by off-line OCT analysis
Time frame: At 6 months after stent implantation
Percentage of incomplete apposed struts assessed by off-line OCT analysis
Time frame: At 6 months after stent implantation
Healing score assessed by off-line OCT analysis
Time frame: At 6 months after stent implantation
Acute success (device and procedural)
Time frame: At baseline
Device-oriented composite endpoints (cardiac death, MI not clearly attributable to a non-intervention vessel, clinically indicated target lesion revascularization)
Time frame: At 1, 6 and 12 months after stent implantation
Myocardial infarction (Q-wave, Non q-wave)
Time frame: At 1, 6 and 12 months after stent implantation
Clinically indicated revascularization of the target vessel
Time frame: At 1, 6 and 12 months after stent implantation
Any revascularization
Time frame: At 1, 6 and 12 months after stent implantation
Stent thrombosis according to ARC definitions
Time frame: Up to 12 months after stent implantation
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