Carotid Artery StenosesNCT02501148
A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
An observational study of Carotid Artery Stenoses, run by Contego Medical, Inc. at 5 sites in Germany.
Trial summary
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenoses
- What is being tested?
- carotid artery stenting
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 5 sitesGermany
- Study dates
- Aug 2015to Oct 2016
- How long will I take part?
- 30 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults; either gender; requiring percutaneous intervention of an asymptomatic (> 70%) or symptomatic (>50%) internal carotid artery stenosis.
Who may be able to join
- Documented stenotic atherosclerotic lesion located at carotid bifurcation and / or proximal internal carotid artery (ICA)
- Subject is either (A) symptomatic within 6 months of procedure, with an ipsilateral carotid stenosis ≥ 50% by angiography, or (B) asymptomatic with carotid stenosis ≥ 70% by angiography
- Target lesion can be covered by a single stent of no more than 40 mm in length
- Target lesion reference vessel diameter (RVD) is 4.0 mm - 7.0mm
- Sufficient landing zone required for successful deployment of integrated embolic protection filter
- Willing to comply with all follow-up required study visits
- Provision of written informed consent before index procedure
Who cannot join
- Life expectancy of less than one year
- An evolving, acute or recent stroke within 14 days of study evaluation
- Acute myocardial infarction within 72 hours before procedure
- Known sensitivity to contrast media that cannot be adequately controlled with pre-medication
- Subject has a total occlusion of target carotid artery
- Subject has a previously place stent in ipsilateral carotid artery
Show all 12Show fewer
- Severe circumferential lesion calcification that may restrict full deployment of carotid stent
- Presence of filling defect or thrombus in target vessel
- Presence of "string sign" of target vessel
- Carotid (intracranial) stenosis located distal to target lesion
- Greater than 50% stenosis of common carotid artery proximal to target lesion.
- Known mobile plaque in aortic arch
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Universitäts-Herzzentrum Bad Krozingen
Bad Krozingen, 79189
Sankt Gertrauden Krankenhaus
Berlin
CardioVascular Centre Frankfurt
Frankfurt
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
Hamburg
Universitätsklinikum Leipzig
Leipzig
About this study
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.
- Conditions
- Carotid Artery Stenoses
- Being tested
- carotid artery stenting
- Keywords
- Embolic protection, Carotid artery stenting
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid artery stentingDevice
Also called Paladin Post-Dilation Balloon System with Integrated Embolic Protection
Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection
| Study group | Role | What they receive |
|---|---|---|
| Carotid artery stenting | Symptomatic and asymptomatic subjects requiring carotid artery stenting, post-dilation performed using the Paladin System with integrated embolic protection Receives: Device: carotid artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related MAE
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionOct 2016
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 Carotid Artery StenosesStudies 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
- 106 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Contego Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Thomas Zeller, MD, Principal investigator, Universitäts Herzzentrum Freiburg Bad-KrozingenProf. Horst Sievert, MD, Principal investigator, CardioVascular Center, Sankt Katharinen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501148
- Sponsor's protocol ID
- CSP-1001
- Status last verified
- Nov 2022
- First submitted
- 15 Jul 2015
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langhoff R, Schofer J, Scheinert D, Schmidt A, Sedgewick G, Saylors E, Sachar R, Sievert H, Zeller T. Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic Protection. JACC Cardiovasc Interv. 2019 Feb 25;12(4):395-403. doi: 10.1016/j.jcin.2018.11.039.
PubMed 30784647
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
- ClinicalTrials.gov ID
- NCT02501148
- Acronym / sponsor ID
- CSP-1001
- Conditions
- Carotid Artery Stenoses
- Keywords
- Embolic protection, Carotid artery stenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Contego Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Jul 2015 (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.
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid artery stenting | – | Device: carotid artery stentingSymptomatic and asymptomatic subjects requiring carotid artery stenting, post-dilation performed using the Paladin System with integrated embolic protection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults; either gender; requiring percutaneous intervention of an asymptomatic (> 70%) or symptomatic (>50%) internal carotid artery stenosis.
Key inclusion criteria (7 listed)
- Documented stenotic atherosclerotic lesion located at carotid bifurcation and / or proximal internal carotid artery (ICA)
- Subject is either (A) symptomatic within 6 months of procedure, with an ipsilateral carotid stenosis ≥ 50% by angiography, or (B) asymptomatic with carotid stenosis ≥ 70% by angiography
- Target lesion can be covered by a single stent of no more than 40 mm in length
- Target lesion reference vessel diameter (RVD) is 4.0 mm - 7.0mm
- Sufficient landing zone required for successful deployment of integrated embolic protection filter
Key exclusion criteria (12 listed)
- Life expectancy of less than one year
- An evolving, acute or recent stroke within 14 days of study evaluation
- Acute myocardial infarction within 72 hours before procedure
- Known sensitivity to contrast media that cannot be adequately controlled with pre-medication
- Subject has a total occlusion of target carotid artery
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 |
|---|---|---|
| carotid artery stentingAlso: Paladin Post-Dilation Balloon System with Integrated Embolic ProtectionPost-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection | Device | Carotid artery stenting |
Primary outcome
Device-related MAE
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 30784647Langhoff R, Schofer J, Scheinert D, Schmidt A, Sedgewick G, Saylors E, Sachar R, Sievert H, Zeller T. Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic Protection. JACC Cardiovasc Interv. 2019 Feb 25;12(4):395-403. doi: 10.1016/j.jcin.2018.11.039.
- Double Filtration During Carotid Artery Stenting Using a Novel Post-Dilation Balloon With Integrated Embolic ProtectionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Prof. Thomas Zeller, MD principal investigator
Universitäts Herzzentrum Freiburg Bad-Krozingen
Prof. Horst Sievert, MD principal investigator
CardioVascular Center, Sankt Katharinen Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenoses, run by Contego Medical, Inc. at 5 sites 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related MAE (time frame: 30 days). 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 NCT02501148, 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 21 Nov 2022.