Revive AIS Patients ImmeDiately (RAPID)

A Multicenter, Prospective Registry Clinical Study of the Effectiveness and Safety of ReVive SE Thrombectomy for Acute Ischemic Stroke

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke; Occlusion, Cerebrovascular
• Intervention / Treatment: Device: Revive SE intracranial thrombectomy device

Detailed Description

This is a multi-center, prospective, single-arm observational study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke patients using Revive SE device on the basis of standardised medical treatment.The device selection before treatment is based upon doctors who are blinded to the protocol. The primary outcomes are reperfusion rate immediately after intervention (mTICI score ≥II b ) and mRS Score at 90 days after intervention.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Peng-fei Yang, MD; Phone Number: 15921196312; Email: 15921196312@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. . history of intracranial hemorrhage.
2. . life expectancy <90 days;
3. . history of major surgery or severe trauma in the past 10 days;
4. . 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)
5. . PLT<40*10^9/L；
6. . blood glucose <2.7mmol /L or >22. 2 mmol /L；
7. . concomitant use of oral anticoagulation drugs, and INR >3.0；
8. . ASPECTS score ≤5；
9. . conventional angiography indicates poor collateral circulation (ACG Score ≤ 1).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		3 months
Procedure time	the time take to achieve successful reperfusion (from groin puncture to reperfusion)	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
Device or intervention related adverse events		within 90 days after intervention

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Jian-min Liu, MD, Department of Neurosurgery, Changhai hospital, Shanghai

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Estimate): January 6, 2017
• Last Update Submitted That Met QC Criteria: January 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: endovascular treatment; human; mechanical thrombectomy; stent retriever
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Cerebrovascular Disorders
• Other Study ID Numbers: CHEC2016-119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided