Prospective, Post Market Surveillance Q3-registry (POLARIS)
Sponsored by QualiMed Innovative Medizinprodukte GmbH
About this trial
Last updated 11 years ago
Study ID
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Ended 8 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- 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 Criteria
- 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