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

Flanders Medical Research Program

Status and phase: Completed; Phase 3; Phase 2

Conditions: Peripheral Arterial Disease

Treatments: Device: RoadSaver stent

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02529345

FMRP-130919

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

RoadSaver stent

Experimental group

Description:

patient treated with the RoadSaver stent of Terumo

Treatment:

Device: RoadSaver stent