Back to resultsClear-Road Trial, Investigating the Efficacy of the RoadSaver Stent
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
RoadSaver stent
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
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.
- 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.
Sites / Locations
- Imelda Hospital
- OLV Aalst
- AZ Sint-Blasius
- RZ Heilig Hart Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RoadSaver stent
Arm Description
patient treated with the RoadSaver stent of Terumo
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Late Ipsilateral stroke
number of patients presenting late ipsilateral stroke within 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.
device malfunctions
number of device malfunctions during procedure
Major Adverse Events (MAE's)
number of MAE's at the different time frames
serious device-related and procedure-related Adverse Events (SAE's)
number of SAE's at the different time frames
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.
in-stent restenosis (ISR)
patients representing ISR at the different time frames
Full Information
NCT ID
NCT02529345
First Posted
April 27, 2015
Last Updated
July 31, 2017
Sponsor
Flanders Medical Research Program
1. Study Identification
Unique Protocol Identification Number
NCT02529345
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flanders Medical Research Program
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RoadSaver stent
Arm Type
Experimental
Arm Description
patient treated with the RoadSaver stent of Terumo
Intervention Type
Device
Intervention Name(s)
RoadSaver stent
Intervention Description
lesion treated with RoadSaver stent of Terumo
Primary Outcome Measure Information:
Title
30-day rate of Major Adverse events (MAE)
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Late Ipsilateral stroke
Description
number of patients presenting late ipsilateral stroke within day 31 through 365 days
Time Frame
day 31 through 365 days
Title
System Technical Success
Description
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.
Time Frame
procedure (day 0)
Title
device malfunctions
Description
number of device malfunctions during procedure
Time Frame
procedure (day 0)
Title
Major Adverse Events (MAE's)
Description
number of MAE's at the different time frames
Time Frame
at 1,6 and 12 month follow-up
Title
serious device-related and procedure-related Adverse Events (SAE's)
Description
number of SAE's at the different time frames
Time Frame
at 1, 6 and 12 month follow-up
Title
freedom from Target Lesion Revascularization (TLR)
Description
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.
Time Frame
at 1, 6 and 12-month follow-up
Title
in-stent restenosis (ISR)
Description
patients representing ISR at the different time frames
Time Frame
at 1, 6 and 12 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bosiers, MD
Organizational Affiliation
A.Z. Sint-Blasius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
State/Province
Antwerp
ZIP/Postal Code
2820
Country
Belgium
Facility Name
OLV Aalst
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ Sint-Blasius
City
Dendermonde
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9200
Country
Belgium
Facility Name
RZ Heilig Hart Hospital
City
Tienen
ZIP/Postal Code
3300
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Clear-Road Trial, Investigating the Efficacy of the RoadSaver Stent
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