Peripheral Artery DiseaseQ3-RegistryNCT02307292
Prospective, Post Market Surveillance Q3-registry (POLARIS)
An observational study of Peripheral Artery Disease, run by QualiMed Innovative Medizinprodukte GmbH at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- POLARIS Peripheral Vascular Self Expanding Stent System
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Apr 2017
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with single significant (>50%) superficial femoral artery disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
HGZ Bad Bevensen, Department of Angiology
Bad Bevensen, 29549
Hans Krankenberg, MD, PhD, +495821821157, h.krankenberg@hgz-bb.de
About this study
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.
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
- Conditions
- Peripheral Artery Disease
- Being tested
- POLARIS Peripheral Vascular Self Expanding Stent System
- Keywords
- Superficial femoral artery, Self Expanding Stent System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POLARIS Peripheral Vascular Self Expanding Stent SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from target lesion revascularization
Clinically driven
Measured: at 12 months
Secondary outcomes (5)
Binary restenosis/ reocclusion
Defined as peak systolic velocity tatio (PSVR) > 2.4
Measured: at 12 months
Target limb amputation at the index leg (major and minor separately)
Measured: at 12 months
All-cause death
Measured: at 12 months
Change in resting ankle brachial index (ABI)
Measured: From baseline to 12 and 24 months
Change in Rutherford Classification
Measured: From baseline to 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- QualiMed Innovative Medizinprodukte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hans Krankenberg, Herz- und Gefaesszentrum Bad Bevensen
- Investigators
- Hans Krankenberg, MD,PhD, Principal investigator, Cardiovascular Center Bad Bevensen, Department of Angiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307292
- Sponsor's protocol ID
- QualiMed
- Acronym
- Q3-Registry
- Status last verified
- Jan 2015
- First submitted
- 18 Nov 2014
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34994234
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02307292
- Acronym / sponsor ID
- Q3-Registry / QualiMed
- Conditions
- Peripheral Artery Disease
- Keywords
- Superficial femoral artery, Self Expanding Stent System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- QualiMed Innovative Medizinprodukte GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with single significant (>50%) superficial femoral artery disease
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POLARIS Peripheral Vascular Self Expanding Stent System | Device | – |
Primary outcome
Freedom from target lesion revascularization
Time frame: at 12 months
Clinically driven
5 secondary outcomes
Binary restenosis/ reocclusion
Time frame: at 12 months
Target limb amputation at the index leg (major and minor separately)
Time frame: at 12 months
All-cause death
Time frame: at 12 months
Change in resting ankle brachial index (ABI)
Time frame: From baseline to 12 and 24 months
Change in Rutherford Classification
Time frame: From baseline to 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
- Derived from this study: PubMed 34994234Thieme 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Krankenberg, MD,PhD principal investigator
Cardiovascular Center Bad Bevensen, Department of Angiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by QualiMed Innovative Medizinprodukte GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sigrid Krimmer-Quendler, PhD (+40417165780, quendler@qualimed.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from target lesion revascularization (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.