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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529345
• Other study ID #: FMRP-130919
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 27, 2015
• Last updated: July 31, 2017
• Start date: April 2015
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• RoadSaver stent
lesion treated with RoadSaver stent of Terumo

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst	Oost-Vlaanderen
Belgium	Imelda Hospital	Bonheiden	Antwerp
Belgium	AZ Sint-Blasius	Dendermonde	Oost-Vlaanderen
Belgium	RZ Heilig Hart Hospital	Tienen

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Late Ipsilateral stroke	number of patients presenting late ipsilateral stroke within day 31 through 365 days	day 31 through 365 days
Secondary	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)
Secondary	device malfunctions	number of device malfunctions during procedure	procedure (day 0)
Secondary	Major Adverse Events (MAE's)	number of MAE's at the different time frames	at 1,6 and 12 month follow-up
Secondary	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
Secondary	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
Secondary	in-stent restenosis (ISR)	patients representing ISR at the different time frames	at 1, 6 and 12 month follow-up