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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: RoadSaver stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RoadSaver stent<br>patient treated with the RoadSaver stent of Terumo | Device: RoadSaver stent<br>* lesion treated with RoadSaver stent of Terumo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day rate of Major Adverse events (MAE) | 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). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Ipsilateral stroke | number of patients presenting late ipsilateral stroke within day 31 through 365 days | day 31 through 365 days | 
| System Technical Success | 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. | procedure (day 0) | 
| device malfunctions | number of device malfunctions during procedure | procedure (day 0) | 
| Major Adverse Events (MAE's) | number of MAE's at the different time frames | at 1,6 and 12 month follow-up | 
| serious device-related and procedure-related Adverse Events (SAE's) | number of SAE's at the different time frames | at 1, 6 and 12 month follow-up | 
| freedom from Target Lesion Revascularization (TLR) | 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. | at 1, 6 and 12-month follow-up | 
| in-stent restenosis (ISR) | patients representing ISR at the different time frames | at 1, 6 and 12 month follow-up |