Overview

This trial is active, not recruiting.

Condition peripheral arterial disease
Treatment roadsaver stent
Phase phase 2/phase 3
Sponsor Flanders Medical Research Program
Start date April 2015
End date April 2016
Trial size 100 participants
Trial identifier NCT02529345, FMRP-130919

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
patient treated with the RoadSaver stent of Terumo
roadsaver stent
lesion treated with RoadSaver stent of Terumo

Primary Outcomes

Measure
30-day rate of Major Adverse events (MAE)
time frame: 30 days

Secondary Outcomes

Measure
Late Ipsilateral stroke
time frame: day 31 through 365 days
System Technical Success
time frame: procedure (day 0)
device malfunctions
time frame: procedure (day 0)
Major Adverse Events (MAE's)
time frame: at 1,6 and 12 month follow-up
serious device-related and procedure-related Adverse Events (SAE's)
time frame: at 1, 6 and 12 month follow-up
freedom from Target Lesion Revascularization (TLR)
time frame: at 1, 6 and 12-month follow-up
in-stent restenosis (ISR)
time frame: at 1, 6 and 12 month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title CLEAR-ROAD; a Physician-initiated Carotid Trial Investigating the Efficacy of Endovascular Treatment of Carotid Arterial Disease With the Multi-layer RoadSaver Stent
Principal investigator Marc Bosiers, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Flanders Medical Research Program.