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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 : August 20, 2019
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

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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 +32483534106 Tamara.Sals@terumo-europe.com

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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: August 20, 2019
Last Verified: August 2019
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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Constriction, Pathologic
Carotid Stenosis
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases