Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03496415
Other study ID # 2017-NEAT
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 3, 2018
Est. completion date January 1, 2019

Study information

Verified date November 2018
Source Capital Medical University
Contact Xunming Ji, MD
Phone 008601083198930
Email jixm@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 210
Est. completion date January 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Xuanwu Hospital, Capital Medical University Beijing Beijing
China Shengli Oilfield Center Hospital Dongying Shandong
China Nanyang City Center Hospital Nanyang
China Suzhou Municipal Hoapital Suzhou An Hui
China The First Affiliated Hospital of Zhengzhou University Zhengzhou
China The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Occurrence of adverse events and serious adverse events Occurrence of adverse events and serious adverse events 30 days
Primary The presence of =1 new brain lesions on DWI Assessed by DWI within 72 hours after endovascular treatment
Secondary Number of new ischemic lesions within 72 hours after endovascular treatment
Secondary Volume of new ischemic lesions within 72 hours after endovascular treatment
Secondary 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. 7 days or discharge
Secondary Cerebrovascular events Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA. 30 days
Secondary Nondisabling events Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.National Institutes of Health Stroke Scale =3 or TIA is defined as nondisabling events 30 days
Secondary Modified Rankin Scale Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death). 30 days
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06235619 - Arch Size Study for Anatomical Variations
Not yet recruiting NCT00905931 - Lycopene Following Aneurysmal Subarachnoid Haemorrhage Phase 2
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A
Completed NCT00349908 - A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries Phase 1
Recruiting NCT03285100 - The Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation N/A
Recruiting NCT06189950 - Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE N/A
Active, not recruiting NCT04592185 - The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms
Completed NCT01970605 - Silver Graft All Comers Registry
Completed NCT00282893 - Balloon Prophylaxis of Aneurysmal Vasospasm Phase 2
Active, not recruiting NCT00549380 - Clinical Study of Aneurysm Exclusion Phase 1
Completed NCT04598802 - COvera in BRAnch Registry
Completed NCT04246125 - Patient Skin Dose in Interventional Radiology
Recruiting NCT05829746 - PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS N/A
Completed NCT03242343 - VasQ External Support for Arteriovenous Fistula N/A
Recruiting NCT02878967 - Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain Aneurysm
Active, not recruiting NCT02345005 - Iliac Branch Excluder ReGistry (IceBERG)
Recruiting NCT02167997 - EffectiveNess and SAfety of Small ANeurysm COiling Trial N/A
Recruiting NCT00549016 - Clinical Study of Aneurysm Exclusion N/A
Completed NCT02848612 - Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
Enrolling by invitation NCT04269447 - Prospective Aortic Biobank of POP-STAR