Prospective, Post Market Surveillance Q3-registry (POLARIS)
Q3-Registry
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.
1 other identifier
observational
250
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedJanuary 12, 2015
January 1, 2015
2.3 years
November 18, 2014
January 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from target lesion revascularization
Clinically driven
at 12 months
Secondary Outcomes (5)
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
Change in Rutherford Classification
From baseline to 12 and 24 months
Interventions
Eligibility Criteria
Patients with single significant (\>50%) superficial femoral artery disease
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HGZ Bad Bevensen, Department of Angiology
Bad Bevensen, 29549, Germany
Related Publications (1)
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.
PMID: 34994234DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans Krankenberg, MD,PhD
Cardiovascular Center Bad Bevensen, Department of Angiology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
November 18, 2014
First Posted
December 4, 2014
Study Start
December 1, 2014
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
January 12, 2015
Record last verified: 2015-01