NCT03561311

Brief Summary

The overall incidence of DWI positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 6, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

May 23, 2018

Last Update Submit

November 21, 2018

Conditions

Aneurysm, RupturedCoiling Therapy

Outcome Measures

Primary Outcomes (1)

  • The presence of ≥1 new brain lesions on DWI

    Assessed by DWI

    within 72 hours after endovascular treatment

Secondary Outcomes (6)

  • Number of new ischemic lesions

    within 72 hours after endovascular treatment

  • Volume of new ischemic lesions

    within 72 hours after endovascular treatment

  • National Institutes of Health Stroke Scale

    7 days or discharge

  • Composite of Cerebrovascular events

    30 days

  • Nondisabling events

    30 days

  • +1 more secondary outcomes

Other Outcomes (1)

  • Occurrence of adverse events and serious adverse events

    30 days

Study Arms (2)

Remote ischemic conditioning group

EXPERIMENTAL
Device: remote ischemic conditioning

Sham remote ischemic conditioning group

SHAM COMPARATOR
Device: sham remote ischemic conditioning

Interventions

remote ischemic conditioningDEVICE

Remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mm Hg during the ischemic period (Patent No. CN200820123637.X, China)

Remote ischemic conditioning group
sham remote ischemic conditioningDEVICE

Sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg

Sham remote ischemic conditioning group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Ruptured brain aneurysm deemed suitable for neuroendovascular repair
  • Normal baseline brain MRI
  • Female subjects of childbearing potential have a negative pregnancy test.
  • Signed informed consent prior to entering study

You may not qualify if:

  • Dissecting or mycotic brain aneurysm.
  • Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment
  • Renal insufficiency with creatinine ≥ 265 umol/L
  • Severe, sustained hypertension (SBP \> 185 mmHg or DBP \> 110 mmHg)
  • Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs
  • Pre-morbid modified Rankin scale score of greater than 1
  • Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations Patients who are unable to have an MRI scan for any reason.
  • Currently participating or previously participated in any investigational drug or device study within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

NOT YET RECRUITING

Shengli Oilfield Central Hospital

Dongying, Shandong, China

RECRUITING

The Second People's Hospital of Liaocheng

Liaocheng, China

RECRUITING

Nanyang City Center Hospital

Nanyang, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Aneurysm, Ruptured

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular Diseases

Central Study Contacts

Xunming Ji, MD

CONTACT

008601083198930jixm@ccmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 19, 2018

Study Start

October 6, 2018

Primary Completion

May 31, 2019

Study Completion

June 30, 2019

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

CN(5)