NCT02501148

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

5 active sites

Status
completed

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

July 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

July 15, 2015

Last Update Submit

November 16, 2022

Conditions

Carotid Artery Stenoses

Keywords

Embolic protectionCarotid artery stenting

Outcome Measures

Primary Outcomes (1)

  • Device-related MAE

    30 days

Study Arms (1)

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

carotid artery stentingDEVICE

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
Carotid artery stenting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Universitäts-Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Sankt Gertrauden Krankenhaus

Berlin, Germany

Location

CardioVascular Centre Frankfurt

Frankfurt, Germany

Location

Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

Hamburg, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30784647BACKGROUND

Related Links

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Prof. Thomas Zeller, MD

    Universitäts Herzzentrum Freiburg Bad-Krozingen

    PRINCIPAL INVESTIGATOR

  • Prof. Horst Sievert, MD

    CardioVascular Center, Sankt Katharinen Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 17, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(5)