Prospective, Post Market Surveillance Q3-registry (POLARIS)
- Conditions
- Peripheral Artery Disease
- Registration Number
- NCT02307292
- Lead Sponsor
- QualiMed Innovative Medizinprodukte GmbH
- 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 Stent System
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from target lesion revascularization at 12 months Clinically driven
- Secondary Outcome Measures
Name Time Method Binary restenosis/ reocclusion at 12 months Defined as peak systolic velocity tatio (PSVR) \> 2.4
Target limb amputation at the index leg (major and minor separately) at 12 months All-cause death at 12 months Change in resting ankle brachial index (ABI) From baseline to 12 and 24 months Change in Rutherford Classification From baseline to 12 and 24 months
Trial Locations
- Locations (1)
HGZ Bad Bevensen, Department of Angiology
🇩🇪Bad Bevensen, Germany