A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection

November 16, 2022 updated by: Contego Medical, Inc.
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

106

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

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  • 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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection
Other Names:
  • Paladin Post-Dilation Balloon System with Integrated Embolic Protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Device-related MAE
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

Contego Medical, Inc.

Investigators

  • Principal Investigator: Prof. Thomas Zeller, MD, Universitäts Herzzentrum Freiburg Bad-Krozingen
  • Principal Investigator: Prof. Horst Sievert, MD, CardioVascular Center, Sankt Katharinen Hospital

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

Helpful Links

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 (Actual)

August 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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