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

Sponsor
Contego Medical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02501148
Collaborator
(none)
106
Enrollment
1
Location
14
Actual Duration (Months)
7.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: carotid artery stenting

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
106 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Device-related MAE [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitäts-Herzzentrum Bad Krozingen Bad Krozingen Germany 79189

    Sponsors and Collaborators

    • Contego Medical, Inc.

    Investigators

    • Study Director: Ravish Sachar, MD, Contego Medical, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Contego Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT02501148
    Other Study ID Numbers:
    • CSP-1001
    First Posted:
    Jul 17, 2015
    Last Update Posted:
    Apr 4, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Contego Medical, Inc.
    Embolic protection
    Carotid artery stenting
    Additional relevant MeSH terms:
    Carotid Stenosis

    Study Results

    No Results Posted as of Apr 4, 2017