Ischemic StrokeRAPIDNCT03007082
Revive AIS Patients ImmeDiately
An observational study of Ischemic Stroke and Occlusion, Cerebrovascular, run by Changhai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Occlusion, Cerebrovascular
- What is being tested?
- Revive SE intracranial thrombectomy device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke patients in a time window of 6 hours and received thrombectomy treatment using Revive SE device
Who may be able to join
- 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
Who cannot join
- . 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；
Show all 9Show fewer
- . concomitant use of oral anticoagulation drugs, and INR >3.0；
- . ASPECTS score ≤5；
- . conventional angiography indicates poor collateral circulation (ACG Score ≤ 1).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai hospital
Shanghai, Shanghai Municipality, 200433
Peng-fei Yang, MD, 15921196312, 15921196312@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke, Occlusion, Cerebrovascular
- Being tested
- Revive SE intracranial thrombectomy device
- Keywords
- endovascular treatment, mechanical thrombectomy, stent retriever, human
- Medical subject headings
- Ischemic Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revive SE intracranial thrombectomy deviceDevice
- Intra-arterial mechanical thrombectomy with Revive SE；
- According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion
What is being measured
The primary outcome is the main question the study is designed to answer.
Reperfusion rate (mTICI≥2b)
The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory
Measured: immediately after thrombectomy procedure
Functional outcome
the percentage of functional independence as assessed by mRS (modified Rankin Scale) score<3
Measured: 3 months after thrombectomy procedure
Secondary outcomes (7)
Procedure time
the time take to achieve successful reperfusion (from groin puncture to reperfusion)
Measured: within 3 hours after groin puncture
Number of passes of ReVive SE for each patient
Measured: within 3 hours after groin puncture
Incidence of downstream embolization
Measured: within 3 hours after groin puncture
Incidence of embolization into new territories during intervention
Measured: within 3 hours after groin puncture
Incidence of symptomatic intracranial hemorrhage
Measured: within 24 hours after operation
Mortality
Measured: 3 months
Device or intervention related adverse events
Measured: within 90 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-min Liu, Changhai Hospital
- Investigators
- Jian-min Liu, MD, Principal investigator, Department of Neurosurgery, Changhai hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007082
- Sponsor's protocol ID
- CHEC2016-119
- Acronym
- RAPID
- Status last verified
- Jan 2017
- First submitted
- 1 Dec 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 31175375
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Registry Clinical Study of the Effectiveness and Safety of ReVive SE Thrombectomy for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03007082
- Acronym / sponsor ID
- RAPID / CHEC2016-119
- Conditions
- Ischemic Stroke, Occlusion, Cerebrovascular
- Keywords
- endovascular treatment, mechanical thrombectomy, stent retriever, human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients in a time window of 6 hours and received thrombectomy treatment using Revive SE device
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- . 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revive SE intracranial thrombectomy device1. Intra-arterial mechanical thrombectomy with Revive SE； 2. According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion | Device | – |
Primary outcome
Reperfusion rate (mTICI≥2b)
Time frame: immediately after thrombectomy procedure
The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory
Functional outcome
Time frame: 3 months after thrombectomy procedure
the percentage of functional independence as assessed by mRS (modified Rankin Scale) score<3
7 secondary outcomes
Procedure time
Time frame: within 3 hours after groin puncture
Number of passes of ReVive SE for each patient
Time frame: within 3 hours after groin puncture
Incidence of downstream embolization
Time frame: within 3 hours after groin puncture
Incidence of embolization into new territories during intervention
Time frame: within 3 hours after groin puncture
Incidence of symptomatic intracranial hemorrhage
Time frame: within 24 hours after operation
Mortality
Time frame: 3 months
Device or intervention related adverse events
Time frame: within 90 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
- Derived from this study: PubMed 31175375Zhang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-min Liu, MD principal investigator
Department of Neurosurgery, Changhai hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Occlusion, Cerebrovascular, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng-fei Yang, MD (15921196312 ext. +86, 15921196312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reperfusion rate (mTICI≥2b) (time frame: immediately after thrombectomy procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017; AzTrials last refreshed its copy on 29 Oct 2026.