NCT02169492

Brief Summary

The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

2.4 years

First QC Date

June 13, 2014

Last Update Submit

August 4, 2017

Conditions

Stroke

Keywords

ThrombectomyStrokeReVive SE

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale

    Functional Independence of subjects as defined by modified Rankin Scale (mRS) ≤2 at 90 days post-procedure.

    90 days

Secondary Outcomes (1)

  • National Institute of Health Stroke Scale (NIHSS)

    90 days

Other Outcomes (3)

  • emboli occurence

    90

  • symptomatic intracranial hemorrhage (sICH)

    90 days

  • Mortality

    90 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects requiring mechanical thrombectomy

You may qualify if:

  • Age ≥ 18 years old
  • Clinical signs consistent with acute ischemic stroke
  • No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
  • NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE
  • Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE.
  • Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours
  • Subject or legally authorized representative has provided informed consent on data collection, and consent is documented

You may not qualify if:

  • Life expectancy of less than 90 days
  • Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation)
  • Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke
  • Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent)
  • Known bleeding diathesis:
  • Current use of oral anticoagulants (eg, warfarin sodium) with International Normalized Ratio (INR) \> 3;
  • Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or
  • Platelet count \< 100,000/mm3
  • Glucose \<50 mg/dL (2.8 mmol, 2.6mM)
  • Uncontrolled hypertension (SBP\>185 or DBP\>110) refractory to pharmacological management
  • Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents
  • Pregnancy or lactating female
  • Subject already enrolled in a clinical study involving experimental medication or device
  • CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor.
  • Angiographic evidence of carotid dissection, or high grade stenosis (\> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or cerebral vasculitis
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CHU Bordeaux

Bordeaux, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, France

Location

CHU de Colmar

Colmar, France

Location

CHU Dijon

Dijon, France

Location

CHU Lille

Lille, France

Location

CHU La Timone

Marseille, France

Location

CHU St Etienne

Saint-Etienne, France

Location

Hôpital Bretonneau

Tours, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Benjamin Hoehn, MD

    Codman Neuro

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 23, 2014

Study Start

January 1, 2015

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

August 7, 2017

Record last verified: 2017-08

Locations

FR(8)