- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02317081
Axetis Inert Coronary Stent System First In Man Clinical Investigation (AXETIS FIM)
June 25, 2015 updated by: Axetis AG
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Silvio Schaffner
- Email: axetis@gmx.ch
Study Locations
-
-
-
Amsterdam, Netherlands
- Recruiting
- AMC Amsterdam, Netherlands
-
Contact:
- Joanna Wykrzykowska, MD PhD FESC
- Phone Number: +31630387425
- Email: J.J.Wykrzykowska@amc.uva.nl
-
Enschede, Netherlands
- Recruiting
- Thoraxcentrum Twente, Medisch Spectrum
-
Contact:
- Clemens Von Birgelen, MD
- Phone Number: +31053489
- Email: c.vonbirgelen@mst.nl
-
Nieuwegein, Netherlands
- Recruiting
- St. Antonius
-
Contact:
- Benno Rensing, MD
- Phone Number: +31306092274
- Email: b.rensing@wxs.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Axetis Inert Coronary Stents
Axetis Inert Coronary Stents for de novo coronary lesion
|
de novo coronary artery stenosis in native vessels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
In-stent Late Lumen Loss (LLL) assessed by off-line QCA
Time Frame: 6 months after stent implantation
|
6 months after stent implantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Lumen gain
Time Frame: Post intervention (1 hour)
|
Angiographic endpoint MLD (mm); Diameter Stenosis (%); Binary Restenosis (DS ≥50%)
|
Post intervention (1 hour)
|
Acute area gain
Time Frame: Post intervention (1 hour)
|
Optical coherence tomography end point
|
Post intervention (1 hour)
|
Percent Acute device success
Time Frame: 1 day post intervention
|
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
|
1 day post intervention
|
late lumen loss
Time Frame: 6 months after intervention
|
Angiographic endpoint
|
6 months after intervention
|
maximal neointimal thickness
Time Frame: 6 months after intervention
|
OCT
|
6 months after intervention
|
Percent procedural success
Time Frame: post intervention (1 hour)
|
post intervention (1 hour)
|
|
Number of adverse cardiac events
Time Frame: 12 months after intervention
|
clinical endpoint
|
12 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yvonne Teunissen, PhD, Cardialysis BV
- Principal Investigator: Mariann Gyöngyösi, Prof. MD, University Hospital, Cardiology, Vienna, Austria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
November 19, 2014
First Submitted That Met QC Criteria
December 12, 2014
First Posted (Estimate)
December 15, 2014
Study Record Updates
Last Update Posted (Estimate)
June 29, 2015
Last Update Submitted That Met QC Criteria
June 25, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AXETIS FIM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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