Acute Ischemic StrokeNCT04315844
The Trial of Ewata Balloon Guiding in the Application of Thrombectomy
A study testing Ewata balloon guiding in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and security of Ewata combined with a stent device in the treatment of acute ischemic stroke within 8 hours To prove whether the clinical efficacy and safety of Ewata r is not inferior to other guidings. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Ewata balloon guiding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2017to 30 Sep 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke
- within 8 hours
- Patients aged 18-80 years (including critical point)
- NIHSS score 4-30 (including critical points)
- Pre-onset mRS score <2
- Large vessel lesions were detected by head CT, CTA, MRI, MRA, or DSA
- The patient or his legal guardian voluntarily signs and dates a written informed 8.consent approved by the ethics committee (IBC).
Who cannot join
- Head CT exclusion criteria (exclusion if any of the following conditions are met)
- Cerebral hemorrhage
- Intracranial tumors, except for small meningiomas
- Large area of early cerebral infarction (low density shadow >1/3 cerebral hemisphere)
- Clinical and laboratory exclusion criteria
- seizure
Show all 22Show fewer
- Symptoms of nervous system loss improved rapidly
- Severe stroke (NIHSS≥31 points) or mild stroke (NIHSS≤3 points)
- CT examination of the skull was negative, but subarachnoid hemorrhage was not excluded from clinical symptoms
- A history of intracranial hemorrhage and subarachnoid hemorrhage
- A history of cranial trauma in the last 3 months
- A history of cerebral or myocardial infarction in the last 3 months
- A history of gastrointestinal or urinary tract bleeding in the last 3 weeks
- A history of major surgery in the last 2 weeks
- A history of arterial puncture in the last l weeks that was difficult to stop bleeding
- Patients with severe cardiac, hepatic or renal insufficiency (>250 mol/L) or severe diabetes mellitus
- Physical examination revealed evidence of active bleeding or trauma, such as a fracture
- Oral anticoagulants have been taken, and INR>1.7
- Blood glucose <2.7 mmol/L or >22.2 mmol/L
- Systolic blood pressure >185 mmHg, or diastolic blood pressure >110 mmHg Pregnancy
- There is a tendency of severe bleeding or bleeding disease, platelet count ≤80x109 /L
- Systemic infection without control or local infection of puncture point Hypersensitivity to contrast media
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy and security of Ewata combined with a stent device in the treatment of acute ischemic stroke within 8 hours To prove whether the clinical efficacy and safety of Ewata r is not inferior to other guidings.
Read the detailed description
This clinical trial uses multicenter, single-arm, prospective trial design,people who met the enrollment requirements were performed with Ewata balloon guiding and stent type thrombectomy device.The clinical results were compared with those of other historical guiding catheter products combined with the stent type thrombectomy device to to evaluate the clinical efficacy and safety of Ewata balloon guide catheter in combination with a stent for thrombectomy.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Ewata balloon guiding
- Keywords
- AIS balloon guiding
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ewata balloon guidingDevice
The balloon guide catheter is coaxial cavity and reinforced braided catheter with varying stiffness echelon.The distal end is marked by an impermeable ray, the proximal end has a bifurcated ruhr interface, and the end is embedded with a compliance balloon.The product label indicates the size of the balloon guide catheter and the maximum volume of the balloon.
| Study group | Role | What they receive |
|---|---|---|
| balloon | Experimental | To evaluate the efficacy and security of Ewata combined with a stent device in the treatment of acute ischemic stroke within 8 hours To prove whether the clinical efficacy and safety of Ewata r is not inferior to other guidings. Receives: Device: Ewata balloon guiding |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical success rate of ewata
When the balloon guiding catheter arrives at the desired location, the thrombectomy instrument can enter the balloon guiding catheter smoothly, which can be opened successfully when needed to form a local blockage of blood flow. After the thrombectomy, the thrombectomy instrument can be withdrawn back into the guide catheter, which is considered as a success.Ewata balloon guide catheter should be used at least once during thrombectomy
Measured: intraoperative
Secondary outcomes (9)
Rate of Vascular recanalization
TICI≥2b
Measured: postoperative
Rate of intraoperative adverse events
including vascular perforation , incision,vasospasm caused by balloon guiding,balloon guide catheter rupture and other instrument-related accidents
Measured: intraoperative
The time from the successful puncture to the expected location of ewata
time data
Measured: intraoperative
The time from successful puncture to recanalization
time data,TICI≥2b
Measured: intraoperative
Rate of symptomatic intracranial hemorrhage within 24 hours
CT/NIHSS
Measured: 24 hours
24-hour mortality
The number of all deaths reported will be recorded and adjudicated
Measured: 24-hour
90-day mortality
The number of all deaths reported will be recorded and adjudicated
Measured: 90-day
Good prognosis rate at 90 days
(mRS≤2)
Measured: 90 days
The thrombus escapes from the target vessel to other vessels to form new embolism
The form of New thrombosis Judged by DSA or MRA
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start25 Jul 2017
- Primary completion30 Jun 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongrong Miao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315844
- Sponsor's protocol ID
- LCXY-02-01
- Status last verified
- Nov 2020
- First submitted
- 18 Mar 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trial of Ewata Balloon Guiding in the Application of Thrombectomy
- ClinicalTrials.gov ID
- NCT04315844
- Acronym / sponsor ID
- LCXY-02-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- AIS balloon guiding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 20 Mar 2020 (actual)
- 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.
To evaluate the efficacy and security of Ewata combined with a stent device in the treatment of acute ischemic stroke within 8 hours To prove whether the clinical efficacy and safety of Ewata r is not inferior to other guidings.
Detailed description
This clinical trial uses multicenter, single-arm, prospective trial design,people who met the enrollment requirements were performed with Ewata balloon guiding and stent type thrombectomy device.The clinical results were compared with those of other historical guiding catheter products combined with the stent type thrombectomy device to to evaluate the clinical efficacy and safety of Ewata balloon guide catheter in combination with a stent for thrombectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| balloon | Experimental | Device: Ewata balloon guidingTo evaluate the efficacy and security of Ewata combined with a stent device in the treatment of acute ischemic stroke within 8 hours To prove whether the clinical efficacy and safety of Ewata r is not inferior to other guidings. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute ischemic stroke
- within 8 hours
- Patients aged 18-80 years (including critical point)
- NIHSS score 4-30 (including critical points)
- Pre-onset mRS score <2
Key exclusion criteria (22 listed)
- Head CT exclusion criteria (exclusion if any of the following conditions are met)
- Cerebral hemorrhage
- Intracranial tumors, except for small meningiomas
- Large area of early cerebral infarction (low density shadow >1/3 cerebral hemisphere)
- Clinical and laboratory exclusion criteria
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 |
|---|---|---|
| Ewata balloon guidingThe balloon guide catheter is coaxial cavity and reinforced braided catheter with varying stiffness echelon.The distal end is marked by an impermeable ray, the proximal end has a bifurcated ruhr interface, and the end is embedded with a compliance balloon.The product label indicates the size of the balloon guide catheter and the maximum volume of the balloon. | Device | balloon |
Primary outcome
technical success rate of ewata
Time frame: intraoperative
When the balloon guiding catheter arrives at the desired location, the thrombectomy instrument can enter the balloon guiding catheter smoothly, which can be opened successfully when needed to form a local blockage of blood flow. After the thrombectomy, the thrombectomy instrument can be withdrawn back into the guide catheter, which is considered as a success.Ewata balloon guide catheter should be used at least once during thrombectomy
9 secondary outcomes
Rate of Vascular recanalization
Time frame: postoperative
Rate of intraoperative adverse events
Time frame: intraoperative
The time from the successful puncture to the expected location of ewata
Time frame: intraoperative
The time from successful puncture to recanalization
Time frame: intraoperative
Rate of symptomatic intracranial hemorrhage within 24 hours
Time frame: 24 hours
24-hour mortality
Time frame: 24-hour
90-day mortality
Time frame: 90-day
Good prognosis rate at 90 days
Time frame: 90 days
The thrombus escapes from the target vessel to other vessels to form new embolism
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ewata balloon guiding in people with Acute Ischemic Stroke, run by Beijing Tiantan 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 22 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: finished, as of the sponsor's last update on 5 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical success rate of ewata (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2020.