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

Phase 2

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: RoadSaver stent

• Registration Number: NCT02529345
• Lead Sponsor: Flanders Medical Research Program

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Primary Completion: 2016-04
• Study Completion: 2017-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RoadSaver stent	RoadSaver stent	patient treated with the RoadSaver stent of Terumo

Primary Outcome Measures

Name	Time	Method
30-day rate of Major Adverse events (MAE)	30 days	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

Name	Time	Method
Late Ipsilateral stroke	day 31 through 365 days	number of patients presenting late ipsilateral stroke within day 31 through 365 days
Major Adverse Events (MAE's)	at 1,6 and 12 month follow-up	number of MAE's at the different time frames
System Technical Success	procedure (day 0)	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	procedure (day 0)	number of device malfunctions during procedure
serious device-related and procedure-related Adverse Events (SAE's)	at 1, 6 and 12 month follow-up	number of SAE's at the different time frames
in-stent restenosis (ISR)	at 1, 6 and 12 month follow-up	patients representing ISR at the different time frames
freedom from Target Lesion Revascularization (TLR)	at 1, 6 and 12-month follow-up	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.

Trial Locations

Locations (4)

OLV Aalst; 🇧🇪 Aalst, Oost-Vlaanderen, Belgium

RZ Heilig Hart Hospital; 🇧🇪 Tienen, Belgium

AZ Sint-Blasius; 🇧🇪 Dendermonde, Oost-Vlaanderen, Belgium

Imelda Hospital; 🇧🇪 Bonheiden, Antwerp, Belgium