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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: RoadSaver stent

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Tienen, Belgium, 3300
    • RZ Heilig Hart Hospital
  • Antwerp
    • Bonheiden, Antwerp, Belgium, 2820
      • Imelda Hospital
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • OLV Aalst
    • Dendermonde, Oost-Vlaanderen, Belgium, 9200
      • AZ Sint-Blasius

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RoadSaver stent; patient treated with the RoadSaver stent of Terumo	Device: RoadSaver stent; lesion treated with RoadSaver stent of Terumo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program
• Investigators: Principal Investigator: Marc Bosiers, MD, A.Z. Sint-Blasius Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (ESTIMATE): August 20, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FMRP-130919