NCT03496415

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 May 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

6 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

March 22, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

May 3, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

March 22, 2018

Last Update Submit

November 21, 2018

Conditions

Aneurysm

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

  • 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

EXPERIMENTAL
Device: remote ischemic conditioning

Sham remote ischemic conditioning

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
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

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Unruptured 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
  • 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 (6)

Suzhou Municipal Hoapital

Suzhou, Anhui, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

NOT YET RECRUITING

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

NOT YET RECRUITING

Shengli Oilfield Center Hospital

Dongying, Shandong, 257034, China

RECRUITING

Nanyang City Center Hospital

Nanyang, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular 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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 12, 2018

Study Start

May 3, 2018

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

CN(6)