Revive AIS Patients ImmeDiately

Ischemic Stroke Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03007082
• Other study ID #: CHEC2016-119
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2016
• Last updated: January 5, 2017
• Start date: November 2016
• Est. completion date: February 2018

Study information

• Verified date: January 2017
• Source: Changhai Hospital
• Contact: Peng-fei Yang, MD
• Phone: 15921196312
• Email: 15921196312[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Ischemia
• Ischemic Stroke
• Occlusion, Cerebrovascular
• Stroke

Intervention

Device:
• Revive SE intracranial thrombectomy device
Intra-arterial mechanical thrombectomy with Revive SE; According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Functional outcome	the percentage of functional independence as assessed by mRS (modified Rankin Scale) score<3	3 months after thrombectomy procedure	No
Secondary	Procedure time	the time take to achieve successful reperfusion (from groin puncture to reperfusion)	within 3 hours after groin puncture	No
Secondary	Number of passes of ReVive SE for each patient		within 3 hours after groin puncture	No
Secondary	Incidence of downstream embolization		within 3 hours after groin puncture	Yes
Secondary	Incidence of embolization into new territories during intervention		within 3 hours after groin puncture	Yes
Secondary	Incidence of symptomatic intracranial hemorrhage		within 24 hours after operation	Yes
Secondary	Mortality		3 months	Yes
Secondary	Device or intervention related adverse events		within 90 days after intervention	Yes