Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients (ESCAPE)

December 3, 2018 updated by: Ji Xunming,MD,PhD, Capital Medical University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanyang, China
        • Recruiting
        • Nanyang City Center Hospital
        • Contact:
      • Zhengzhou, China
        • Not yet recruiting
        • the First Affiliated Hospital of Zhengzhou University
    • An Hui
      • Suzhou, An Hui, China
        • Not yet recruiting
        • Suzhou Municipal Hoapital
    • Beijing
      • Beijing, Beijing, China, 100069
        • Recruiting
        • Xuan Wu Hospital，Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 101149
        • Recruiting
        • Lu He hospital, Capital Medical University
        • Contact:
    • Shandong
      • Dongying, Shandong, China
        • Not yet recruiting
        • Shengli Oilfield Central Hospital
        • Contact:
          • Zongen Gao
        • Principal Investigator:
          • Zongen Gao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Balloon guide catheter group
mechanical thrombectomy with a balloon guide catheter group
Device: Balloon guide catheter
Use a balloon guide catheter in the mechanical thrombectomy
Active Comparator: Non-balloon guide catheter group
mechanical thrombectomy with a non-balloon guide catheter group
Device: Non-balloon guide catheter
Use a non-balloon guide catheter in the mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Distal embolization,
Time Frame: After mechanical thrombectomy, usually within 3 hours
After mechanical thrombectomy, usually within 3 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
90 days
National Institutes of Health Stroke Scale
Time Frame: 7 days or discharge
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
7 days or discharge
Modified thrombolysis in cerebral infarction 2b/3,
Time Frame: After mechanical thrombectomy, usually within 3 hours
After mechanical thrombectomy, usually within 3 hours
Modified thrombolysis in cerebral infarction
Time Frame: After mechanical thrombectomy, usually within 3 hours
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
After the first pass, , usually within 3 hours
First pass recanalization rate
Time Frame: After the first pass, , usually within 3 hours
After the first pass, , usually within 3 hours
Number of passes
Time Frame: After mechanical thrombectomy, usually within 3 hours
After mechanical thrombectomy, usually within 3 hours
Procedure time
Time Frame: From the procedure start to the end, usually within 3 hours
From the procedure start to the end, usually within 3 hours
Symptomatic intracranial hemorrhage
Time Frame: 24 hours
24 hours
Modified Rankin Scale
Time Frame: 90 days
Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).
90 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Safety (occurrence of adverse events and serious adverse events)
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-ESCAPE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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