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

NCT02529345 | Completed Phase 2 DMC

• 1 other identifier: FMRP-130919
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Late Ipsilateral stroke

  day 31 through 365 days

• System Technical Success

  procedure (day 0)

• device malfunctions

  procedure (day 0)

• Major Adverse Events (MAE's)

  at 1,6 and 12 month follow-up

• serious device-related and procedure-related Adverse Events (SAE's)

  at 1, 6 and 12 month follow-up

Study Arms (1)

RoadSaver stent

EXPERIMENTAL

patient treated with the RoadSaver stent of Terumo

Device: RoadSaver stent

Interventions

RoadSaver stent DEVICE

lesion treated with RoadSaver stent of Terumo

RoadSaver stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (4)

Imelda Hospital

Bonheiden, Antwerp, 2820, Belgium

Location

OLV Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

AZ Sint-Blasius

Dendermonde, Oost-Vlaanderen, 9200, Belgium

Location

RZ Heilig Hart Hospital

Tienen, 3300, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Marc Bosiers, MD

  A.Z. Sint-Blasius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: August 20, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

BE (4)