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

NCT ID: NCT02529345

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-05-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RoadSaver stent

patient treated with the RoadSaver stent of Terumo

Group Type: EXPERIMENTAL

RoadSaver stent

Intervention Type: DEVICE

lesion treated with RoadSaver stent of Terumo

Interventions

RoadSaver stent

lesion treated with RoadSaver stent of Terumo

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

A.Z. Sint-Blasius Hospital

Locations

Imelda Hospital

Bonheiden, Antwerp, Belgium

OLV Aalst

Aalst, Oost-Vlaanderen, Belgium

AZ Sint-Blasius

Dendermonde, Oost-Vlaanderen, Belgium

RZ Heilig Hart Hospital

Tienen, , Belgium

Countries

Belgium

Other Identifiers

FMRP-130919

Identifier Type: -

Identifier Source: org_study_id