Clear-Road Trial, Investigating the Efficacy of the RoadS... | NCT02529345

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

NCT02529345

Sponsor

Flanders Medical Research Program

Status

Completed

Last Update Posted

Aug 1, 2017Actual

Enrollment

100Actual

Phase

Phase 2Phase 3

Conditions

Peripheral Arterial Disease

Interventions

RoadSaver stent

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015Actual

Primary Completion Date

Apr 2016Actual

Completion Date

May 2017Actual

First Submitted Date

Apr 27, 2015

First Submission Date that Met QC Criteria

Aug 19, 2015

First Posted Date

Aug 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2017

Last Update Posted Date

Aug 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Label	Type	Description	Intervention Names
RoadSaver stent	Experimental	patient treated with the RoadSaver stent of Terumo	Device: RoadSaver stent

Name	Type	Description	Arm Group Labels	Other Names
RoadSaver stent	Device	lesion treated with RoadSaver stent of Terumo	RoadSaver stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Late Ipsilateral stroke	number of patients presenting late ipsilateral stroke within day 31 through 365 days	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.

Other Outcomes

Not provided

Eligibility Module

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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Imelda Hospital		Bonheiden	Antwerp	2820	Belgium
OLV Aalst

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases