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

January 9, 2015 updated by: Hans Krankenberg, QualiMed Innovative Medizinprodukte GmbH

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.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Bevensen, Germany, 29549
        • Recruiting
        • HGZ Bad Bevensen, Department of Angiology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binary restenosis/ reocclusion
Time Frame: at 12 months
Defined as peak systolic velocity tatio (PSVR) > 2.4
at 12 months
Target limb amputation at the index leg (major and minor separately)
Time Frame: at 12 months
at 12 months
All-cause death
Time Frame: at 12 months
at 12 months
Change in resting ankle brachial index (ABI)
Time Frame: From baseline to 12 and 24 months
From baseline to 12 and 24 months
Change in Rutherford Classification
Time Frame: From baseline to 12 and 24 months
From baseline to 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QualiMed Innovative Medizinprodukte GmbH

Investigators

  • Principal Investigator: Hans Krankenberg, MD,PhD, Cardiovascular Center Bad Bevensen, Department of Angiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

January 12, 2015

Last Update Submitted That Met QC Criteria

January 9, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QualiMed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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