Status:
UNKNOWN
Prospective, Post Market Surveillance Q3-registry (POLARIS)
Lead Sponsor:
QualiMed Innovative Medizinprodukte GmbH
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
19+ years
Brief Summary
This is a prospective, non-randomized post market surveillance registry designed to document the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self Expanding Ste...
Eligibility Criteria
Inclusion
- Age \>18 years
- Single target de novo superficial femoral artery lesion (angiographic evidence of \>50% Stenosis or occlusion) by visual estimate
- Rutherford category II-IV
- At least one patent outflow artery to the ankle.
- Patient signed the informed consent
Exclusion
- Patient with acute or subacute Thrombus
- Patients with hyperkoagulopathy
- Patients with Stenosis or occlusion where lesion crossing with guide wire is not possible
- Pregnancy or positive pregnancy test
- Previous enrolment in this Trial or other industrial Trials
- Patient´s inability to fully cooperate with the registry protocol Patient with cancer Treatment (life expectancy less than 2 years) Patients with renal failure
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2017
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT02307292
Start Date
December 1 2014
End Date
April 1 2017
Last Update
January 12 2015
Active Locations (1)
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1
HGZ Bad Bevensen, Department of Angiology
Bad Bevensen, Germany, 29549