The objective is to assess the feasibility and safety of the Axetis Inert Stent for treatment of 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 endpoint is in-stent Late Lumen Loss (LLL) at 6 months after stent
implantation as assessed by off-line QCA.
Secondary outcome
Angiographic endpoints:
* Acute Lumen Gain (mm);
* 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
* 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
Quantitative and Qualitative assessment:
* Residual edge dissections
* Thrombus (intraluminal mass)
Clinical endpoints:
* Acute success (device and procedural success)
* Device-oriented Composite Endpoints at 6 months and 12 months
(Device-oriented Composite Endpoint (DoCE) is defined as Cardiac Death, MI not
clearly attributable to a non-intervention vessel, and clinically-indicated
TargetLesionRevascularization) and its individual components.
* Stent thrombosis according to the ARC definitions up to 12 months follow-up.
Background summary
One or two of the patients' coronary arteries has a significant narrowing that
is causing decreased blood flow to your heart muscle. To prevent damage to the
heart muscle, this narrowing has to be resolved. This is commonly done with a
percutaneous coronary intervention (PCI). The procedure is performed by
entering the arteries with a catheter trough your groin or arm. By X-ray, the
coronary arteries are made visible. A balloon and then a stent are placed
within the narrowing in the artery to achieve the desired result; a reopened
artery with good blood flow.
Stent placement means that a small metal scaffold (stent) is left behind after
the balloon is removed and the stent becomes a permanent part of the artery.
Stents have been used for many years to treat narrowing of both coronary
arteries and bypass grafts (saphenous vein grafts). The Axetis Inert Stent is a
standard stent with a special surface treatment which have shown in
pre-clinical studies significant reduction of restenosis or re-narrowing of the
artery after the treatment. The procedure itself is a standard procedure for
this condition.
Study objective
The objective is to assess the feasibility and safety of the Axetis Inert Stent
for treatment of patients with de novo coronary artery stenosis in native
vessels.
Study design
Prospective, multicentre, open-label and single arm study, conducted in 2 to 3
interventional cardiology centers in The Netherlands. In total, approximately
35 patients will be enrolled. All patients will be treated with Axetis Inert
Coronary Stent System
Clinical follow-up will occur at 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) and at 6 months follow-up.
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.
Intervention
Axetis Inert Stent
Study burden and risks
Potential Risks
The coating on the stent is tested in depth and the materials used are well
known, there is little potential to cause side effects. Long term animal
studies performed showed the stent does not have toxic or damaging effects on
the body. However, if the patient experiences any signs of an allergic reaction
such as rash, itching or swelling, he/she should inform the study team
(cardiology department) immediately. Previous stent implantation studies
involving the use of antiplatelet have shown a 1 to 2 % chance of blood
clotting within the stent.
This treatment may involve some additional risks to the patient, the nature of
which is unknown. Potential risks in case of pregnancy are not known for this
treatment and the use of adequate birth control during the course of the study
is mandatory for women in their fertile period.
Potential complications and adverse effects due to the use of this stent are
the same to any routinely performed coronary stenting procedure and therapy.
Potential Benefits
The Axetis Inert stent, a Bare Metal Stent with a special surface treatment,
and has shown very promising results in pre-clinical studies. It shows an
important lowering of restenosis or re-narrowing of the artery after the
treatment compared to conventional Bare Metal Stents. In addition, the Axetis
Inert Stent has also shown to become completely part of the inner lining of the
artery, reducing the risk for late stent thrombosis.
Grafenauweg 4
Zug CH-6300
CH
Grafenauweg 4
Zug CH-6300
CH
Listed location countries
Age
Inclusion criteria
*18 to 85 years
*Evidence of myocardial ischemia without elevated Troponin / cardiac biomarkers (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study). NSTEMI patients are allowed, as long as Troponin is within the normal limits before the start of the procedure.
*The patient has a planned intervention of up to two de-novo lesions in two different vessels (previously untreated vessels)
*Lesion must have a visually estimated diameter stenosis of *50% and <100%.
*Lesion length must be * 28 mm
*RVD must be between 2.4 and 3.8 mm
*Written informed consent
*The patient and the patient*s physician agree to the follow-up visits including angiographic follow-up and OCT control at 6 months
Exclusion criteria
- Evidence of ongoing acute myocardial infarction in ECG and or elevated cardiac biomarkers prior to procedure
- 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 (e.g., eGFR <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis)
- History of bleeding diathesis or coagulopathy
- The patient is a recipient of a heart transplant
- Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, ticagrelor and ticlopidine) or stainless steel
- 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
- Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
*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 1, prior to wire crossing
*The target vessel contains visible thrombus
*Restenotic lesion
*Located within an arterial or saphenous vein graft
*Target vessel with previously placed stent or with graft
*Treatment of more than 1 lesion in one vessel, or treatment of more than two lesions
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 | NL44586.018.13 |