Prospective, Non-randomized Post Market Surveillance Registry to Document the Clinical Performance in Routine Clinical Practice of the POLARIS Peripheral Vascular Self Expanding Stent System.

QualiMed Innovative Medizinprodukte GmbH1 site in 1 country250 target enrollmentDecember 2014

ConditionsPeripheral Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: QualiMed Innovative Medizinprodukte GmbH
Enrollment: 250
Locations: 1
Primary Endpoint: Freedom from target lesion revascularization
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

April 2017

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

QualiMed Innovative Medizinprodukte GmbH

Responsible Party

Principal Investigator

Hans Krankenberg

MD PhD

Herz- und Gefaesszentrum Bad Bevensen

Eligibility Criteria

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

Outcomes

Primary Outcomes

Freedom from target lesion revascularization

Time Frame: at 12 months

Clinically driven

Secondary Outcomes

Change in Rutherford Classification(From baseline to 12 and 24 months)
Binary restenosis/ reocclusion(at 12 months)
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)