The objective is to assess the feasibility and safety of the Qvanteq*s bioactive coronary Qstent for treatment of stable coronary artery disease patients with de novo coronary artery stenosis in native vessels.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary Angiographic endpoint is in-stent Late Lumen Loss (LLL) at 6 months
after stent implantation as assessed by off-line QCA.
The primary OCT endpoint is mean neointimal thickness as assessed by OCT at 6
months by off-line OCT analysis.
Secondary outcome
Angiographic endpoints:
• Acute Lumen Gain (mm);
• In-segment Late Lumen Loss (LLL) at 6 months;
• MLD (mm) post procedure and at 6 months;
• Diameter Stenosis (%) post procedure and at 6 months;
• Binary Restenosis (DS >=50%) at 6 months.
All measurements will be made of the in-stent, in-segment, proximal and distal
stent margins
OCT endpoints:
Quantitative assessment at baseline
• prolapse area/volume
Quantitative assessment (at baseline and at 6 months follow-up):
• Mean/Minimal Lumen diameter/area/volume
• Mean/Minimal Stent diameter/area/volume
• Stent symmetry
• Stent expansion
• Incomplete strut apposition
Quantitative assessment (at 6 months follow-up):
• In-stent neointimal hyperplasia volume obstruction (%)
• Neointimal hyperplasia area/volume
• Mean/maximal thickness of the struts coverage
• Percentage number of covered struts
• Percentage of incomplete apposed struts
• Healing Score
Quantitative and Qualitative assessment:
• Residual edge dissections
• Thrombus (intraluminal mass)
Clinical endpoints:
• Acute success (device and procedural success)
• Device-oriented Composite Endpoints at 1, 6 and 12 months and its individual
components (Device-oriented Composite Endpoint (DoCE) is defined as Cardiac
Death, MI not clearly attributable to a non-intervention vessel, and
clinically-indicated Target Lesion Revascularization).
• Death at all timepoints
• Myocardial infarction (Q-wave, Non q-wave) at all timepoints
• Revascularization of the target vessel, clinically indicated at all timepoints
• Any revascularization at all timepoints
• Stent thrombosis according to the ARC definitions up to 12 months follow-up.
Background summary
The introduction of newer generation DES have improved both the safety and
efficacy compared to BMS and early generation DES. Nevertheless, the risk of
late stent thrombosis and the associated need for prolonged dual antiplatelet
therapy remains an important clinical caveat. European and American society of
cardiology recommend a DAPT duration of 1 year following implantation of DES in
view of an increased risk of stent thrombosis mainly observed in observational
(all comers) studies. Reasons for an increased risk of stent thrombosis
following DES implantation are mainly the impaired healing of DES with a delay
in endothelialisation and an increased inflammatory response (granuloma
formation). Whilst the shortening of DAPT may carry the risk of an increased
risk of stent thrombosis following DES implantation, any prolongation of DAPT
goes along with an increased bleeding risk.
An ideal situation would be achieved with a stent device, which shows optimal
healing properties, specifically a fast endothelialisation (similar to BMS), a
low degree of inflammation and a sustained efficacy based on a minimal
neointimal proliferation (comparable to DES). Such a device by definition
would not require a prolonged DAPT throughout one year (similar to a BMS) and
thereby limit the bleeding risk. Particularly for patients with an increased
bleeding risk or for patients requiring oral anticoagulation (triple therapy,
approximately in 8% of patients undergoing PCI), the avoidance of a DAPT for
more than 1-3 months would be beneficial to decrease the risk for DAPT induced
bleeding.
The Qstent is a Cobalt Chromium stent which underwent Qvanteq*s proprietary
surface treatment. The development goal for Qvanteq*s surface treated Qstent is
to achieve a fast endothelial growth (similar to a BMS), which however is not
resulting in an excessive neointimal hyperplasia as observed in BMS but rather
has an efficacy profile similar to DES. This should reduce the risk of
restenosis and thrombus formation despite the presence of a short term DAPT.
Both in-vitro and in-vivo studies have shown positive promising results with
Qvanteq*s surface treated stents regarding this.
Study objective
The objective is to assess the feasibility and safety of the Qvanteq*s
bioactive coronary Qstent for treatment of stable coronary artery disease
patients with de novo coronary artery stenosis in native vessels.
Study design
Prospective, multicentre, open-label and single arm study, conducted in
approximately 5 interventional cardiology centers in Switzerland and the
Netherlands. In total, approximately 35 patients will be enrolled. All patients
will be treated with the Qstent (bioactive stent, Qvanteq AG, Zurich,
Switzerland).
Clinical follow-up will occur at 1, 6 and 12 months post-stent implantation.
All patients will undergo repeat angiography at 6 months follow-up. QCA
assessment will be performed at baseline (pre- and post-procedure) and at 6
months follow-up.
All patients will undergo Optical Coherence Tomography (OCT) investigation at
baseline (post procedure, documentary) and at 6 months follow-up. At baseline,
the OCT should be performed after the successfully completed angiographic
procedure (i.e. angiography guided Qstent implantation).
Off-line QCA and OCT analysis will be performed by an independent core
laboratory (Cardialysis BV, Rotterdam, The Netherlands) according to pre-set
Standard Operating Procedures.
Clinical data will be adjudicated by an independent Clinical Event Committee.
An independent Data Safety Monitoring Board (DSMB) will monitor the individual
and collective safety of the patients in the study on an ongoing basis.
Intervention
The patient has a planned intervention of one single de novo lesion in one or
two separate major epicardial territories (LAD, LCX, or RCA).
Study burden and risks
The potential risks are the well-known and common risks associated with any
PCI. Potential complications and adverse effects due to the use of this stent
include, but are not limited to death, stroke/cerebrovascular accidents,
myocardial infarction, stent thrombosis or occlusion of the coronary artery
that was treated, or another coronary artery, need for emergent coronary artery
bypass grafting (CABG) or percutaneous coronary intervention (PCI), procedural
adverse events, such as coronary spasm with myocardial ischemia, perforation or
cardiac tamponade, or dissection, distal embolization (air, tissue or
thrombotic emboli), side branch compromise, bleeding complications, access
vascular complications, such as hematoma, hemorrhage requiring transfusion,
pseudoaneurysm, peripheral ischemia, peripheral nerve injury, infection and
pain at the insertion site, arrhythmias, including ventricular fibrillation or
ventricular tachycardia, hypotension/Hypertension, allergic reaction to
drugs/contrast medium/stent material.
Technoparkstrasse 1
Zürich CH-8005
CH
Technoparkstrasse 1
Zürich CH-8005
CH
Listed location countries
Age
Inclusion criteria
• Subjects must be at least 18 years of age
• Evidence of myocardial ischemia without elevated cardiac biomarkers (e.g. stable or unstable angina with stable haemodynamic condition, or silent ischemia demonstrated by positive territorial functional study)
• The patient has a planned intervention of one single de novo lesion in one or two separate major epicardial territories (LAD, LCX, or RCA)
• Lesion must have a visually estimated diameter stenosis of >=50% and <100%
• Lesion length must be <=16 mm
• Vessel size must be between 2.5 mm and 3.5 mm
• Written informed consent
• The patient agrees to the follow-up visits including angiographic follow-up and OCT control at 6 months
Exclusion criteria
• Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure.
• Patient suffered from stroke/TIA or myocardial infarction during the last 6 months
• Left ventricle ejection fraction (LVEF) <30%
• Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• Known renal insufficiency, or subject on dialysis, or acute kidney failure.
• Patient undergoing planned surgery within 6 months with the necessity to stop ASA
• Patient requiring prolonged DAPT for other diagnoses (>1 month)
• History of bleeding diathesis or coagulopathy
• Patient requiring oral anticoagulation (Coumadin, NOAC)
• The patient is a recipient of a heart transplant
• Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or cobalt-chromium
• Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy
• Female of child bearing potential (age <50 years and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48848.078.14 |