NCT03007082

Brief Summary

This is a multicenter, prospective registry clinical study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE device on the basis of standardised medical treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

December 1, 2016

Last Update Submit

January 5, 2017

Conditions

Ischemic StrokeOcclusion, Cerebrovascular

Keywords

endovascular treatmentmechanical thrombectomystent retrieverhuman

Outcome Measures

Primary Outcomes (2)

  • Reperfusion rate (mTICI≥2b)

    The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory

    immediately after thrombectomy procedure

  • Functional outcome

    the percentage of functional independence as assessed by mRS (modified Rankin Scale) score\<3

    3 months after thrombectomy procedure

Secondary Outcomes (7)

  • Procedure time

    within 3 hours after groin puncture

  • Number of passes of ReVive SE for each patient

    within 3 hours after groin puncture

  • Incidence of downstream embolization

    within 3 hours after groin puncture

  • Incidence of embolization into new territories during intervention

    within 3 hours after groin puncture

  • Incidence of symptomatic intracranial hemorrhage

    within 24 hours after operation

  • +2 more secondary outcomes

Interventions

Revive SE intracranial thrombectomy deviceDEVICE

1. Intra-arterial mechanical thrombectomy with Revive SE； 2. According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion

Eligibility Criteria

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

Acute ischemic stroke patients in a time window of 6 hours and received thrombectomy treatment using Revive SE device

You may qualify if:

  • age over 18 years;
  • clinical diagnosis should be acute ischaemic stroke;
  • no more than 6 hours after onset;
  • IV tPA thrombolysis, if needed, should start within 4.5 hours after onset；
  • Pre-stroke mRS ≤2;
  • ICA/M1/M2/A1/A2/VA/BA occlusion confirmed by CTA/MRA/DSA;'
  • written informed consent form given

You may not qualify if:

  • history of intracranial hemorrhage.
  • life expectancy \<90 days;
  • history of major surgery or severe trauma in the past 10 days;
  • Uncontrolled hypertension (defined as: SBP\>185mmHg or DBP ≥110 mm Hg at 3 continuous measurements with interval of at least 10 minutes confirm the SBP\>185mmHg or DBP ≥110 mm Hg)
  • PLT\<40\*10\^9/L；
  • blood glucose \<2.7mmol /L or \>22. 2 mmol /L；
  • concomitant use of oral anticoagulation drugs, and INR \>3.0；
  • ASPECTS score ≤5；
  • conventional angiography indicates poor collateral circulation (ACG Score ≤ 1).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (1)

  • Zhang Y, Wen W, Chen C, Wu Z, Xiang X, Shi H, Guan S, Jiang G, Peng Y, Li Z, Li Z, Zhang L, Zhang Y, Hong B, Yang P, Liu J. Effectiveness of Revive SE in the RAPID registry : Revive Acute Ischemic Stroke Patients ImmeDiately (RAPID) Prospective Multicenter Trial. Clin Neuroradiol. 2020 Sep;30(3):495-502. doi: 10.1007/s00062-019-00798-w. Epub 2019 Jun 7.

    PMID: 31175375DERIVED

MeSH Terms

Conditions

Ischemic StrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

StrokeBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jian-min Liu, MD

    Department of Neurosurgery, Changhai hospital, Shanghai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng-fei Yang, MD

CONTACT

1592119631215921196312@163.com

Wan-ling Wen, MD

CONTACT

15721571004wwljoy00@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neurosurgery, Changhai hospital

Study Record Dates

First Submitted

December 1, 2016

First Posted

January 2, 2017

Study Start

November 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

CN(1)