BioMimics 3D Stent Clinical Investigation: The Mimics Study (Mimics)
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|ClinicalTrials.gov Identifier: NCT02163863|
Recruitment Status : Unknown
Verified June 2014 by Veryan Medical Ltd..
Recruitment status was: Active, not recruiting
First Posted : June 16, 2014
Last Update Posted : June 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Femoropopliteal stenting||Not Applicable|
The Mimics Study is a prospective, part randomized study; an initial roll-in registry of 10 subjects treated with BioMimics 3D followed by a randomized assignment to treatment with BioMimics 3D or Control on a 2:1 basis for 76 subjects.
The primary purpose of the study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease based on:
- Safety; measured by freedom from major adverse events determined at 30 days after the procedure, compared to historic controls.
- Performance; measured by freedom from clinically driven TLR at 6 months, compared to historic controls.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||BioMimics 3D Stent Clinical Investigation: The Mimics Study|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||July 2014|
Experimental: BioMimics 3D
The BioMimics 3D Stent System, delivering a self-expanding Nitinol stent with 3D helical centerline geometry.
Device: Femoropopliteal stenting
Active Comparator: Control
CR Bard LifeStent System, delivering a self-expanding Nitinol stent
Device: Femoropopliteal stenting
- Primary safety endpoint [ Time Frame: 30 days ]Freedom from major adverse events defined as death, amputation and target lesion revascularization (TLR)
- Primary performance endpoint [ Time Frame: 6 months ]Freedom from clinically driven TLR
- Acute procedural outcomes [ Time Frame: Within 30 days of the procedure ]
- Device deployment success
- Acute procedural success
- Procedural complications
- Post implant anatomical outcomes [ Time Frame: Immediately post implant but within the index procedure ]- Stented vessel geometry, i.e. presence/absence of 3D helical geometry in the stented region
- Mechanical outcomes [ Time Frame: 30 days, 6, 12 and 24 months ]- Stent integrity, i.e. presence/absence of kinks and fractures
- Haemodynamic outcomes [ Time Frame: discharge, 30 days, 6, 12 and 24 months ]
- Restenosis measured by duplex ultrasound and angiography.
- Swirling flow
- Clinical and functional outcomes [ Time Frame: discharge, 30 days, 6, 12 and 24 months ]
- Rutherford classification (not at discharge)
- Walking impairment questionnaire (not at discharge)
- Freedom from major adverse events at 30 days, 6, 12 and 24 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163863
|Principal Investigator:||Thomas Zeller, M.D.||Universitäts-Herzzentrum Freiburg Bad Krozingen|
|Principal Investigator:||Sebastian Sixt, MD||Medizinisches Versorgungszentrum Hamburg|
|Principal Investigator:||Henrik Schroeder, MD||Zentrum für Minimal Invasive Therapie Berlin|
|Principal Investigator:||Horst Sievert, MD||Cardiovascular Center Frankfurt|
|Principal Investigator:||Karl-Ludwig Schulte, MD||Königin Elisabeth Herzberge Berlin|
|Principal Investigator:||Gunnar Tepe, MD||Klinikum Rosenheim|
|Principal Investigator:||Giovanni Torsello, MD||St. Franziskus-Hospital Münster|
|Principal Investigator:||Dierk Scheinert, MD||Park-Krankenhaus Leipzig|