Clinical trial NCT02529345: Clear-Road Trial, Investigating the Efficacy of the RoadSaver Stent
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Peripheral Arterial Disease
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2015-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

  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.

Primary outcomes:
measure: 30-day rate of Major Adverse events (MAE)
timeFrame: 30 days
Secondary outcomes:
measure: Late Ipsilateral stroke
timeFrame: day 31 through 365 days
measure: System Technical Success
timeFrame: procedure (day 0)
measure: device malfunctions
timeFrame: procedure (day 0)
measure: Major Adverse Events (MAE's)
timeFrame: at 1,6 and 12 month follow-up
measure: serious device-related and procedure-related Adverse Events (SAE's)
timeFrame: at 1, 6 and 12 month follow-up
measure: freedom from Target Lesion Revascularization (TLR)
timeFrame: at 1, 6 and 12-month follow-up
measure: in-stent restenosis (ISR)
timeFrame: at 1, 6 and 12 month follow-up
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: Antwerp
city: Aalst
country: Belgium
facility: OLV Aalst
state: Oost-Vlaanderen
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
state: Oost-Vlaanderen
city: Tienen
country: Belgium
facility: RZ Heilig Hart Hospital
Study officials:
affiliation: A.Z. Sint-Blasius Hospital
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References: