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Trial record 8 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

Observational Study to Confirm Safety and Efficacy of the ROADSAVER Stent for the Treatment of Carotid Artery Stenosis (ROADSAVER)

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ClinicalTrials.gov Identifier: NCT03504228
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.

Brief Summary:
Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study. The maximum number of patients enrolled at each site will be not limited. Follow-ups are scheduled at discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up contacts via hospital visit and/or telephone.

Condition or disease Intervention/treatment
Carotid Artery Stenosis Device: ROADSAVER

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective, Single-arm, Multi-center, Observational Study to Further Confirm Safety and Efficacy of the Dual-layer Micromesh Roadsaver Stent for the Treatment of Carotid Artery Stenosis in Patients Eligible for Elective Stenting Procedure
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Intervention Details:
  • Device: ROADSAVER
    Dual layer micromesh Roadsaver carotid stent


Primary Outcome Measures :
  1. The rates of Major Adverse Events (MAE) [ Time Frame: 30 days ]
    Defined as the cumulative incidence of any death or stroke up to 30 days after the index procedure


Secondary Outcome Measures :
  1. Technical Success [ Time Frame: 12 months ]
    Defined as a successful access and deployment of the device with recanalization determined by less than 30% residual stenosis by angiography during the index procedure

  2. Procedural success [ Time Frame: 12 months ]
    Defined as technical success without any device- or procedure-related death, stroke, or any other serious adverse events

  3. MAE [ Time Frame: 12 months ]
    any death or stroke

  4. Death [ Time Frame: 12 months ]
    Stroke related

  5. Major Stroke [ Time Frame: 12 months ]
    Major

  6. Minor Stroke [ Time Frame: 12 months ]
    Minor

  7. TIA [ Time Frame: 12 months ]
    Transient Ischemic Attack

  8. Device malfunction [ Time Frame: 12 months ]
    Defined as the failure of a device after its introduction into the patient

  9. TLR [ Time Frame: 12 months ]
    Target Lesion Revascularization

  10. Major vascular and bleeding complications [ Time Frame: 12 months ]

    Defined as follows:

    • Major hematoma, defined as one requiring transfusion, surgical evacuation, or delay in discharge
    • Pseudo-aneurysm
    • Arteriovenous fistula
    • Retroperitoneal bleeding
    • Peripheral ischemia/nerve injury caused by the proximal access site
    • Vascular surgical repair to correct a local vascular complication and control bleeding



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients included in this study will be comprised of male and female patients derived from general interventional radiology or angiology populations.
Criteria

Inclusion Criteria:

  • The patient has a non-occlusive and non-thrombotic carotid artery stenosis and is eligible to be treated with Roadsaver Carotid Stent as per the Instructions for Use (IFU)
  • The patient is at least 18 years of age
  • The patient has a life expectancy of at least 12 months from the date of the index procedure
  • The patient is able and willing to provide a signed IRB-/EC-approved informed consent form prior to participation

Exclusion Criteria:

- Any condition that makes patient unsuitable for percutaneous transluminal angioplasty (PTA), including intolerance or allergy to any material used and accompanying therapy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504228


Contacts
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Contact: Dragica Paunovic, MD +3216381311 Dragica.Paunovic@terumo-europe.com
Contact: Tamara Sals, MSc +3216381281 Tamara.Sals@terumo-europe.com

Locations
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Belgium
OLV Ziekenhuis Recruiting
Aalst, Belgium
Contact: Roel Beelen, MD         
Principal Investigator: Roel Beelen, MD         
Imelda Ziekenhuis Recruiting
Bonheiden, Belgium
Contact: Jürgen Verbist, MD         
Principal Investigator: Jürgen Verbist, MD         
AZ Sint-Blasius Recruiting
Dendermonde, Belgium
Contact: Koen Deloose, MD         
Principal Investigator: Koen Deloose, MD         
AZ Groeninge Recruiting
Kortrijk, Belgium
Contact: Olivier François, MD         
Principal Investigator: Olivier François, MD         
UZ Leuven Recruiting
Leuven, Belgium
Contact: Kim Daenens, MD         
Principal Investigator: Kim Daenens, MD         
France
GCS Centre de Cardiologie du Pays Basque Recruiting
Bayonne, France
Contact: Jean-Luc Banos, MD         
Principal Investigator: Jean-Luc Banos, MD         
Groupe Hospitalier Mutualiste de Grenoble Recruiting
Grenoble, France
Contact: Benjamin Faurie, MD         
Principal Investigator: Benjamin Faurie, MD         
Germany
Sankt-Gertrauden Krankenhaus Recruiting
Berlin, Germany
Contact: Ralf Langhoff, MD         
Principal Investigator: Ralf Langhoff, MD         
Diakonissenkrankenhaus Flensburg Ev.-Luth. Diakonissenanstalt zu Flensburg Not yet recruiting
Flensburg, Germany
Contact: Stefan Müller-Hülsbeck, MD         
Principal Investigator: Stefan Müller-Hülsbeck, MD         
Cardioangiological Center Bethanien Not yet recruiting
Frankfurt/Main, Germany
Contact: Michael Piorkowski, MD         
Principal Investigator: Michael Dr. Piorkowski, MD         
SRK Karlsbad Not yet recruiting
Karlsbad, Germany
Contact: Christiane Pöckler-Schoeniger, MD         
Principal Investigator: Christiane Pöckler-Schoeniger, MD         
Klinikum Passau Recruiting
Passau, Germany
Contact: Wiebke Kurre, MD         
Principal Investigator: Wiebke Kurre, MD         
SRH Zentralklinikum Suhl Recruiting
Suhl, Germany
Contact: Volker Sesselmann, MD         
Principal Investigator: Volker Dr. Sesselmann, MD         
Hungary
Markusovszky Teaching Hospital Not yet recruiting
Budapest, Hungary
Contact: Istvan Király, MD         
Principal Investigator: Istvan Király, MD         
Moritz Kaposi Teaching Hospital Not yet recruiting
Kaposvár, Hungary
Contact: Zsolt Vajda, MD         
Principal Investigator: Zsolt Vajda, MD         
Bacs-Kiskun County Hospital Recruiting
Kecskemét, Hungary
Contact: Zoltán Ruzsa, MD         
Principal Investigator: Zoltán Ruzsa, MD         
Macedonia, The Former Yugoslav Republic of
University Clinic of Cardiology Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Contact: Sasko Kedev, MD         
Principal Investigator: Sasko Kedev, MD         
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
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Study Director: Dragica Paunovic, MD Terumo

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Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT03504228     History of Changes
Other Study ID Numbers: T130E2
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carotid Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases