Mechanical ThrombectomyPhase 2ESCAPENCT03754738
Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
A Phase 2 study testing Balloon guide catheter and Non-balloon guide catheter in people with Mechanical Thrombectomy and Stroke, run by Capital Medical University at 6 sites in China.
Trial summary
With mechanical thrombectomy now representing standard of care for treatment of acute ischemic stroke secondary to large vessel occlusion, identifying adjunctive techniques that result in improved outcomes for patients with LVO has become an issue of increasing importance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Thrombectomy, Stroke, Balloon Guide Catheter
- What is being tested?
- Balloon guide catheter and Non-balloon guide catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 6 sitesChina
- Study dates
- 25 Nov 2018to 28 Feb 2020
- Phase
- Phase 2
- 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
Who may be able to join
- Age 18 years or older
- A clinical diagnosis of acute stroke, with a deficit on the NIHSS of 2 points or more.
- Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, or DSA.
- Treatment can be initiated (groin puncture) within 6 hours of symptom onset.
- Planning to mechanical thrombectomy with a stenting retriever.
- Signed informed consent prior to entering study.
Who cannot join
- Moderate stenosis, severe stenosis, or occlusion of the ipsilateral extracranial carotid artery.
- Previously deployed stents in the ipsilateral carotid artery.
- Dissections of the ipsilateral carotid artery.
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.
- Baseline platelet count < 50.000/µL.
- Baseline blood glucose of < 50mg/dL or >400mg/dl.
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- Severe, sustained hypertension (SBP > 220 mm Hg or DBP > 110 mm Hg).
- Renal insufficiency with creatinine ≥ 3 mg/dl.
- Patients in sedation and intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation.
- Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
- Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
- Subject participating in a study involving an investigational drug or device that would impact this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100069
xunming ji, 861013120136877, jixunming@vip.163.com
- Recruiting
Lu He hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
Xiaokun Geng, MD, 18311055270, xgeng@ccmu.edu.cn
- Not yet recruiting
Shengli Oilfield Central Hospital
Dongying, Shandong
Zongen Gao
Zongen Gao
- Recruiting
Nanyang City Center Hospital
Nanyang
Changming Wen, 13838729696, wenchangming9587@163.com
- Not yet recruiting
Suzhou Municipal Hoapital
Suzhou, Anhui
Zhengfei Ma, MD
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Yajun Lian
About this study
With mechanical thrombectomy now representing standard of care for treatment of acute ischemic stroke secondary to large vessel occlusion, identifying adjunctive techniques that result in improved outcomes for patients with LVO has become an issue of increasing importance. A number of retrospective studies have demonstrated that flow arrest during the clot retrieval process results in less clot fragmentation, lower rates of distal emboli, higher revascularization rates and improved rates of good neurological outcome.
- Conditions
- Mechanical Thrombectomy, Stroke, Balloon Guide Catheter
- Being tested
- Balloon guide catheter, Non-balloon guide catheter
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon guide catheterDevice
Use a balloon guide catheter in the mechanical thrombectomy
Non-balloon guide catheterDevice
Use a non-balloon guide catheter in the mechanical thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Balloon guide catheter group | Experimental | mechanical thrombectomy with a balloon guide catheter group Receives: Device: Balloon guide catheter |
| Non-balloon guide catheter group | Active comparator | mechanical thrombectomy with a non-balloon guide catheter group Receives: Device: Non-balloon guide catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal embolization,
Measured: After mechanical thrombectomy, usually within 3 hours
Secondary outcomes (10)
Modified thrombolysis in cerebral infarction 2b/3,
Measured: After mechanical thrombectomy, usually within 3 hours
Modified thrombolysis in cerebral infarction
Measured: After mechanical thrombectomy, usually within 3 hours
Modified thrombolysis in cerebral infarction 2b/3 after the first pass
Measured: After the first pass, , usually within 3 hours
First pass recanalization rate
Measured: After the first pass, , usually within 3 hours
Number of passes
Measured: After mechanical thrombectomy, usually within 3 hours
Procedure time
Measured: From the procedure start to the end, usually within 3 hours
National Institutes of Health Stroke Scale
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Measured: 7 days or discharge
Symptomatic intracranial hemorrhage
Measured: 24 hours
Modified Rankin Scale
Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).
Measured: 90 days
Mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start25 Nov 2018 (estimated)
- Primary completion25 Nov 2019 (estimated)
- Study completion28 Feb 2020 (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 Mechanical ThrombectomyStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754738
- Sponsor's protocol ID
- 2018-ESCAPE
- Acronym
- ESCAPE
- Status last verified
- Dec 2018
- First submitted
- 24 Nov 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma H, Che R, Zhang Q, Yu W, Wu L, Zhao W, Li M, Wu D, Wu C, Ji X. The optimum anticoagulation time after endovascular thrombectomy for atrial fibrillation-related large vessel occlusion stroke: a real-world study. J Neurol. 2023 Apr;270(4):2084-2095. doi: 10.1007/s00415-022-11515-y. Epub 2023 Jan 3.
PubMed 36596867
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
- ClinicalTrials.gov ID
- NCT03754738
- Acronym / sponsor ID
- ESCAPE / 2018-ESCAPE
- Conditions
- Mechanical Thrombectomy, Stroke, Balloon Guide Catheter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 25 Nov 2018 (estimated)
- Primary completion
- 25 Nov 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 27 Nov 2018 (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.
With mechanical thrombectomy now representing standard of care for treatment of acute ischemic stroke secondary to large vessel occlusion, identifying adjunctive techniques that result in improved outcomes for patients with LVO has become an issue of increasing importance. A number of retrospective studies have demonstrated that flow arrest during the clot retrieval process results in less clot fragmentation, lower rates of distal emboli, higher revascularization rates and improved rates of good neurological outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon guide catheter group | Experimental | Device: Balloon guide cathetermechanical thrombectomy with a balloon guide catheter group |
| Non-balloon guide catheter group | Active comparator | Device: Non-balloon guide cathetermechanical thrombectomy with a non-balloon guide catheter group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- A clinical diagnosis of acute stroke, with a deficit on the NIHSS of 2 points or more.
- Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, or DSA.
- Treatment can be initiated (groin puncture) within 6 hours of symptom onset.
- Planning to mechanical thrombectomy with a stenting retriever.
Key exclusion criteria (12 listed)
- Moderate stenosis, severe stenosis, or occlusion of the ipsilateral extracranial carotid artery.
- Previously deployed stents in the ipsilateral carotid artery.
- Dissections of the ipsilateral carotid artery.
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.
- Baseline platelet count < 50.000/µL.
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 |
|---|---|---|
| Balloon guide catheterUse a balloon guide catheter in the mechanical thrombectomy | Device | Balloon guide catheter group |
| Non-balloon guide catheterUse a non-balloon guide catheter in the mechanical thrombectomy | Device | Non-balloon guide catheter group |
Primary outcome
Distal embolization,
Time frame: After mechanical thrombectomy, usually within 3 hours
10 secondary outcomes
Modified thrombolysis in cerebral infarction 2b/3,
Time frame: After mechanical thrombectomy, usually within 3 hours
Modified thrombolysis in cerebral infarction
Time frame: After mechanical thrombectomy, usually within 3 hours
Modified thrombolysis in cerebral infarction 2b/3 after the first pass
Time frame: After the first pass, , usually within 3 hours
First pass recanalization rate
Time frame: After the first pass, , usually within 3 hours
Number of passes
Time frame: After mechanical thrombectomy, usually within 3 hours
Procedure time
Time frame: From the procedure start to the end, usually within 3 hours
National Institutes of Health Stroke Scale
Time frame: 7 days or discharge
Symptomatic intracranial hemorrhage
Time frame: 24 hours
Modified Rankin Scale
Time frame: 90 days
Mortality
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Derived from this study: PubMed 36596867Ma H, Che R, Zhang Q, Yu W, Wu L, Zhao W, Li M, Wu D, Wu C, Ji X. The optimum anticoagulation time after endovascular thrombectomy for atrial fibrillation-related large vessel occlusion stroke: a real-world study. J Neurol. 2023 Apr;270(4):2084-2095. doi: 10.1007/s00415-022-11515-y. Epub 2023 Jan 3.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Balloon guide catheter and Non-balloon guide catheter in people with Mechanical Thrombectomy and Stroke, run by Capital Medical University at 6 sites 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 6 inclusion and 12 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distal embolization, (time frame: After mechanical thrombectomy, usually within 3 hours). 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 NCT03754738, 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 4 Dec 2018.