Prospective, Post Market Surveillance Q3-registry (POLARIS)

Peripheral Artery Disease Clinical Trial

— Q3-Registry  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02307292
• Other study ID #: QualiMed
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2014
• Last updated: January 9, 2015
• Start date: December 2014
• Est. completion date: April 2017

Study information

• Verified date: January 2015
• Source: QualiMed Innovative Medizinprodukte GmbH
• Contact: Sigrid Krimmer-Quendler, PhD
• Phone: +40417165780
• Email: quendler[@]qualimed.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• POLARIS Peripheral Vascular Self Expanding Stent System

Locations

Country	Name	City	State
Germany	HGZ Bad Bevensen, Department of Angiology	Bad Bevensen

Sponsors (1)

Lead Sponsor	Collaborator
QualiMed Innovative Medizinprodukte GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from target lesion revascularization	Clinically driven	at 12 months	No
Secondary	Binary restenosis/ reocclusion	Defined as peak systolic velocity tatio (PSVR) > 2.4	at 12 months	Yes
Secondary	Target limb amputation at the index leg (major and minor separately)		at 12 months	Yes
Secondary	All-cause death		at 12 months	Yes
Secondary	Change in resting ankle brachial index (ABI)		From baseline to 12 and 24 months	No
Secondary	Change in Rutherford Classification		From baseline to 12 and 24 months	No