Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigation

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigation

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Qvanteq bioactive coronary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
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, 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). The lesion must have a visually estimated diameter stenosis of ≥ 50% and < 100% Lesion length must be ≤16 mm The vessel size must be between 2.5 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 Key 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 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 (Creatinine clearance less than 30 mL/Min), 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. Previous CABG Angiographic Exclusion Criteria: Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter Target lesion in left main stem. Target lesion involves a side branch > 2.0mm in diameter Aorto-ostial target lesion (within 3 mm of the aorta junction). Total occlusion or TIMI flow <3, prior to wire crossing The target vessel contains visible thrombus Restenotic lesion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qvanteq bioactive coronary stent system<br>Open-label, single arm, non-randomized study | Device: Qvanteq bioactive coronary stent<br>* PCI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Late Lumen Loss (LLL) assessed by off-line QCA |  | At 6 months after stent implantation | 
| Mean neointimal thickness assessed by off-line OCT analysis |  | At 6 months after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute lumen gain assessed by off-line QCA |  | At 6 months after stent implantation | 
| In-segment Late Lumen Loss assessed by off-line QCA |  | At 6 months after stent implantation | 
| Mean Lumen Diameter (MLD) assessed by off-line QCA |  | At 6 months after stent implantation | 
| Diameter stenosis assessed by off-line QCA |  | At 6 months after stent implantation | 
| Binary restenosis (diameter stenosis > = 50%) assessed by off-line QCA |  | At 6 months after stent implantation | 
| Prolapse area/volume assessed by off-line OCT analysis |  | At baseline | 
| Mean/minimal lumen diameter/area/volume assessed by off-line OCT analysis |  | At baseline and at 6 months after stent implantation | 
| Mean/minimal stent diameter/area/volume assessed by off-line OCT analysis |  | At baseline and at 6 months after stent implantation | 
| Stent symmetry assessed by off-line OCT analysis |  | At baseline and at 6 months after stent implantation | 
| Stent expansion assessed by off-line OCT analysis |  | At baseline and at 6 months after stent implantation | 
| Incomplete strut apposition assessed by off-line OCT analysis |  | At baseline and at 6 months after stent implantation | 
| In-stent neointimal hyperplasia volume obstruction (%) assessed by off-line OCT analysis |  | At 6 months after stent implantation | 
| Neointimal hyperplasia area/volume assessed by off-line OCT analysis |  | At 6 months after stent implantation | 
| Mean/maximal thickness of the struts coverage assessed by off-line OCT analysis |  | At 6 months after stent implantation | 
| Percentage number of covered struts assessed by off-line OCT analysis |  | At 6 months after stent implantation | 
| Percentage of incomplete apposed struts assessed by off-line OCT analysis |  | At 6 months after stent implantation | 
| Healing score assessed by off-line OCT analysis |  | At 6 months after stent implantation | 
| Acute success (device and procedural) |  | At baseline | 
| Device-oriented composite endpoints (cardiac death, MI not clearly attributable to a non-intervention vessel, clinically indicated target lesion revascularization) |  | At 1, 6 and 12 months after stent implantation | 
| Myocardial infarction (Q-wave, Non q-wave) |  | At 1, 6 and 12 months after stent implantation | 
| Clinically indicated revascularization of the target vessel |  | At 1, 6 and 12 months after stent implantation | 
| Any revascularization |  | At 1, 6 and 12 months after stent implantation | 
| Stent thrombosis according to ARC definitions |  | Up to 12 months after stent implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD, PCI, bioactive coronary stent, OCT