Prospective, Post Market Surveillance Q3-registry (POLARIS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-04-30

Brief Summary

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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

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Detailed Description

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Conditions

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Peripheral Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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POLARIS Peripheral Vascular Self Expanding Stent System

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No