CompletedNCT02501148Updated Nov 21, 2022

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 in Carotid Artery Stenoses, sponsored by Contego Medical, Inc.. Completed at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-21.

Sponsored by Contego Medical, Inc. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 106
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.

Conditions studied

Carotid Artery Stenoses

Browse trials for

Carotid Stenosis 339

Keywords

Embolic protection
Carotid artery stenting

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 106 is below the median of 173 across 144 observational studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Contego Medical, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Adults; either gender; requiring percutaneous intervention of an asymptomatic (> 70%) or symptomatic (>50%) internal carotid artery stenosis.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 106 participants (actual)
Target follow-up: 30 Days
Patient registry: Yes

Groups and cohorts

Carotid artery stenting
Symptomatic and asymptomatic subjects requiring carotid artery stenting, post-dilation performed using the Paladin System with integrated embolic protection
Device: carotid artery stenting

Interventions

Devicecarotid artery stenting
Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection
Also known as: Paladin Post-Dilation Balloon System with Integrated Embolic Protection

What researchers measure

Primary outcomes

Device-related MAE
Time frame: 30 days

Study locations

5 sites

Universitäts-Herzzentrum Bad Krozingen
Bad Krozingen, 79189, Germany
Sankt Gertrauden Krankenhaus
Berlin, Germany
CardioVascular Centre Frankfurt
Frankfurt, Germany
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
Hamburg, Germany
Universitätsklinikum Leipzig
Leipzig, Germany

References and documents

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 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02501148
Lead sponsor: Contego Medical, Inc.
Responsible party: Sponsor
First posted: Jul 17, 2015
Start date: Aug 2015
Primary completion: Sep 2016
Completion: Oct 2016
Last update: Nov 21, 2022

Study contacts

Prof. Thomas Zeller, MD

principal investigator · Universitäts Herzzentrum Freiburg Bad-Krozingen

Prof. Horst Sievert, MD

principal investigator · CardioVascular Center, Sankt Katharinen Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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