Prospective, Post Market Surveillance Q3-registry (POLARIS) (Q3-Registry)

QualiMed

Status: Unknown

Conditions: Peripheral Artery Disease

Treatments: Device: POLARIS Peripheral Vascular Self Expanding Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT02307292

QualiMed

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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