CLEAR-ROAD; a Physician-initiated Carotid Trial Investigating the Efficacy of Endovascular Treatment of Carotid Arterial Disease With the Multi-layer RoadSaver Stent
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Flanders Medical Research Program
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- 30-day rate of Major Adverse events (MAE)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Late Ipsilateral stroke(day 31 through 365 days)
- Major Adverse Events (MAE's)(at 1,6 and 12 month follow-up)
- System Technical Success(procedure (day 0))
- device malfunctions(procedure (day 0))
- serious device-related and procedure-related Adverse Events (SAE's)(at 1, 6 and 12 month follow-up)
- in-stent restenosis (ISR)(at 1, 6 and 12 month follow-up)
- freedom from Target Lesion Revascularization (TLR)(at 1, 6 and 12-month follow-up)