Prospective, Post Market Surveillance Q3-registry (POLARIS)

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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02307292

Acronym

Q3-Registry

Enrollment

250

Registered

2014-12-04

Start date

2014-12-31

Completion date

2017-04-30

Last updated

2015-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Keywords

Superficial femoral artery, Self Expanding Stent System

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

Interventions

DEVICEPOLARIS Peripheral Vascular Self Expanding Stent System

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Freedom from target lesion revascularization	at 12 months	Clinically driven

Secondary

Measure	Time frame	Description
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	—

Countries

Germany

Contacts

Primary ContactSigrid Krimmer-Quendler, PhD

quendler@qualimed.de+40417165780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026