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

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

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.

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.

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

Exclusion Criteria:

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