Prospective, Post Market Surveillance Q3-registry (POLARIS) | NCT02307292

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

NCT02307292

Sponsor

QualiMed Innovative Medizinprodukte GmbH

Status

Unknown status

Last Update Posted

Jan 12, 2015Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

Peripheral Artery Disease

Interventions

POLARIS Peripheral Vascular Self Expanding Stent System

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Apr 2017Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

Nov 18, 2014

First Submission Date that Met QC Criteria

Dec 3, 2014

First Posted Date

Dec 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2015

Last Update Posted Date

Jan 12, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hans Krankenberg, MD PhD, Herz- und Gefaesszentrum Bad BevensenPrincipal Investigator

Lead Sponsor

QualiMed Innovative Medizinprodukte GmbHINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Name	Type	Description	Arm Group Labels	Other Names
POLARIS Peripheral Vascular Self Expanding Stent System	Device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Binary restenosis/ reocclusion	Defined as peak systolic velocity tatio (PSVR) > 2.4	at 12 months
Target limb amputation at the index leg (major and minor separately)		at 12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with single significant (>50%) superficial femoral artery disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sigrid Krimmer-Quendler, PhD	Contact	+40417165780		quendler@qualimed.de

Overall Officials

Name	Affiliation	Role
Hans Krankenberg, MD,PhD	Cardiovascular Center Bad Bevensen, Department of Angiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HGZ Bad Bevensen, Department of Angiology	Recruiting	Bad Bevensen		29549	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34994234	Derived	Thieme M, Arjumand J, Spanagel M, Tepe G, Blessing E, Kroeg B, Reichert V, Betge S, Wickenhofer R, Tessarek J, Ingwersen M, Krankenberg H. Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry. J Endovasc Ther. 2022 Dec;29(6):904-912. doi: 10.1177/15266028211067726. Epub 2022 Jan 7.

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases