Native Coronary Artery StenosisNCT02317081
Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)
A study testing Axetis Inert Coronary Stents in people with Native Coronary Artery Stenosis, run by Axetis AG at 3 sites in Netherlands.
Trial summary
Prospective, multicenter, single arm study, to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Native Coronary Artery Stenosis
- What is being tested?
- Axetis Inert Coronary Stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesNetherlands
- Study dates
- Feb 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 85 years
- Evidence of myocardial ischemia without elevatedTroponin / 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
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- 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
Who cannot join
- 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
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- 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
- Target vessel with previously placed stent or with graft
- Located within an arterial or saphenous vein graft
- Treatment of more than 1 lesion in one vessel, or treatment of more than two lesions
Trial locations and contacts
3 sites in 1 country.
Silvio Schaffner contact
Netherlands3 sites, 3 recruiting
- Recruiting
AMC Amsterdam, Netherlands
Amsterdam
Joanna Wykrzykowska, MD PhD FESC, +31630387425, J.J.Wykrzykowska@amc.uva.nl
- Recruiting
Thoraxcentrum Twente, Medisch Spectrum
Enschede
Clemens Von Birgelen, MD, +31053489, c.vonbirgelen@mst.nl
- Recruiting
St. Antonius
Nieuwegein
Benno Rensing, MD, +31306092274, b.rensing@wxs.nl
About this study
Prospective, multicenter, single arm study, to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels.
Read the detailed description
Prospective, multicenter, open-label and single arm study, conducted in 3 interventional cardiology centers in The Netherlands. 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. In total, 35 patients will be enrolled. All patients will be treated with Axetis Inert Coronary Stent System. All patients will undergo repeat angiography at 6 months follow-up. Quantitative coronary angiography (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. The primary endpoint is in-stent Late Lumen Loss (LLL) at 6 months after stent implantation as assessed by off-line QCA. Clinical follow-up will occur at 6 and 12 months post-stent implantation.
- Conditions
- Native Coronary Artery Stenosis
- Being tested
- Axetis Inert Coronary Stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axetis Inert Coronary StentsDevice
de novo coronary artery stenosis in native vessels
| Study group | Role | What they receive |
|---|---|---|
| Axetis Inert Coronary Stents | Experimental | Axetis Inert Coronary Stents for de novo coronary lesion Receives: Device: Axetis Inert Coronary Stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent Late Lumen Loss (LLL) assessed by off-line QCA
Measured: 6 months after stent implantation
Secondary outcomes (7)
Acute Lumen gain
Angiographic endpoint MLD (mm); Diameter Stenosis (%); Binary Restenosis (DS ≥50%)
Measured: Post intervention (1 hour)
Acute area gain
Optical coherence tomography end point
Measured: Post intervention (1 hour)
Percent Acute device success
Device-oriented Composite Endpoints (DoCE) at 6 months and 12 months (DoCE is defined as Cardiac Death, MI not clearly attributable to a nonintervention vessel, and clinically-indicated Target Lesion Revascularization and its individual components) Stent thrombosis according to the ARC definitions up to 12 months follow-up
Measured: 1 day post intervention
late lumen loss
Angiographic endpoint
Measured: 6 months after intervention
maximal neointimal thickness
OCT
Measured: 6 months after intervention
Percent procedural success
Measured: post intervention (1 hour)
Number of adverse cardiac events
clinical endpoint
Measured: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Native Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axetis AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvonne Teunissen, PhD, Study director, Cardialysis BVMariann Gyöngyösi, Prof. MD, Principal investigator, University Hospital, Cardiology, Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317081
- Sponsor's protocol ID
- AXETIS FIM
- Status last verified
- Jun 2015
- First submitted
- 19 Nov 2014
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)
- ClinicalTrials.gov ID
- NCT02317081
- Acronym / sponsor ID
- AXETIS FIM
- Conditions
- Native Coronary Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Axetis AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, single arm study, to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels.
Detailed description
Prospective, multicenter, open-label and single arm study, conducted in 3 interventional cardiology centers in The Netherlands. 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. In total, 35 patients will be enrolled. All patients will be treated with Axetis Inert Coronary Stent System. All patients will undergo repeat angiography at 6 months follow-up. Quantitative coronary angiography (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. The primary endpoint is in-stent Late Lumen Loss (LLL) at 6 months after stent implantation as assessed by off-line QCA. Clinical follow-up will occur at 6 and 12 months post-stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axetis Inert Coronary Stents | Experimental | Device: Axetis Inert Coronary StentsAxetis Inert Coronary Stents for de novo coronary lesion |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 85 years
- Evidence of myocardial ischemia without elevatedTroponin / 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%.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axetis Inert Coronary Stentsde novo coronary artery stenosis in native vessels | Device | Axetis Inert Coronary Stents |
Primary outcome
In-stent Late Lumen Loss (LLL) assessed by off-line QCA
Time frame: 6 months after stent implantation
7 secondary outcomes
Acute Lumen gain
Time frame: Post intervention (1 hour)
Acute area gain
Time frame: Post intervention (1 hour)
Percent Acute device success
Time frame: 1 day post intervention
late lumen loss
Time frame: 6 months after intervention
maximal neointimal thickness
Time frame: 6 months after intervention
Percent procedural success
Time frame: post intervention (1 hour)
Number of adverse cardiac events
Time frame: 12 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvio Schaffner contact
Yvonne Teunissen, PhD study director
Cardialysis BV
Mariann Gyöngyösi, Prof. MD principal investigator
University Hospital, Cardiology, Vienna, Austria
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axetis Inert Coronary Stents in people with Native Coronary Artery Stenosis, run by Axetis AG at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvio Schaffner (axetis@gmx.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent Late Lumen Loss (LLL) assessed by off-line QCA (time frame: 6 months after stent implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.