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Completed

NCT Number: NCT02529345

Clear-Road Trial, Investigating the Efficacy of the RoadSaver Stent

The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Imelda Hospital, Bonheiden, Antwerp, Belgium

Loading trial locations.

About this study

It is a Prospective, multi-center, physician-sponsored clinical study.

The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

High risk for carotid endarterectomy due to anatomical or co-morbid conditions and either:

  • has neurological symptoms and ≥ 50% stenosis via angiography, or
  • is asymptomatic and has ≥ 80% stenosis via angiography.
  • Target lesion located in the distal common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation.
  • Arterial segment to be stented has a diameter between 4mm and 9mm
  • Age ≥ 18 years.
  • Life expectancy > 12 months from the date of the index procedure.
  • Provides a signed, IRB (Institutional Review Board) / IEC (Institutional Ethical Committee) approved informed consent form prior to participation.
  • Willing and able to comply with follow-up requirements.

Exclusion criteria

  • Contra-indication to percutaneous transluminal angioplasty (PTA).
  • Sever vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system.
  • Lesions in the ostium of the common carotid artery.
  • Occlusion of the target vessel.
  • Evidence of intraluminal thrombus.
  • Known sensitivity to nickel-titanium.
  • Known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies, or is unable or unwilling to tolerate such therapies.
  • Uncorrectable bleeding disorders, or will refuse block transfusion.
  • History of prior life-threatening contrast media reaction.
  • Previous stent placement in the target vessel.
  • Evolving stroke or intracranial haemorrhage.
  • Previous intracranial haemorrhage or brain surgery within the past 12 months.
  • Clinical condition that makes endovascular therapy impossible or hazardous.

Treatment and study plan

RoadSaver stent

Device

lesion treated with RoadSaver stent of Terumo

Primary outcomes

  1. 30-day rate of Major Adverse events (MAE)

    Time frame: 30 days

    The primary endpoint of this study is the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any peri-procedural (≤ 30 days post-procedure) death, stroke or myocardial infarction (MI).

Secondary outcomes

  1. Late Ipsilateral stroke

    Time frame: day 31 through 365 days

    number of patients presenting late ipsilateral stroke within day 31 through 365 days

  2. System Technical Success

    Time frame: procedure (day 0)

    Defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging.

  3. device malfunctions

    Time frame: procedure (day 0)

    number of device malfunctions during procedure

  4. Major Adverse Events (MAE's)

    Time frame: at 1,6 and 12 month follow-up

    number of MAE's at the different time frames

  5. serious device-related and procedure-related Adverse Events (SAE's)

    Time frame: at 1, 6 and 12 month follow-up

    number of SAE's at the different time frames

  6. freedom from Target Lesion Revascularization (TLR)

    Time frame: at 1, 6 and 12-month follow-up

    Defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal an distal to the treated lesion edge.

  7. in-stent restenosis (ISR)

    Time frame: at 1, 6 and 12 month follow-up

    patients representing ISR at the different time frames

Sponsors and collaborators

Lead sponsor

Flanders Medical Research Program

Network

Registry information

Official study title

CLEAR-ROAD; a Physician-initiated Carotid Trial Investigating the Efficacy of Endovascular Treatment of Carotid Arterial Disease With the Multi-layer RoadSaver Stent

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 20, 2015
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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