NCT05972252

Brief Summary

The objective of this study the first human use of a new device in treatment of acute ischemic stroke, which to evaluate the feasibility, safety, and efficacy of the Cerebrovascular Interventional Procedural Control System.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

July 25, 2023

Last Update Submit

October 16, 2023

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

  • Good Neurological Outcome

    Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms.

    90±7 Days post-treatment

  • Technical Success

    Using Cerebrovascular Interventional Procedural Control System successfully complete the catheters in placement, thrombectomy stent release, and thrombectomy system recovery, without manual conversion.

    Immediately post-treatment

Secondary Outcomes (7)

  • Successful Revascularization

    Immediately post-treatment

  • Time from Groin Puncture to Reperfusion

    Immediately post-treatment

  • Successful Recanalization Rate

    Immediately post-treatment

  • Radiation Exposure

    Immediately post-treatment

  • Symptomatic Intracranial Hemorrhage

    36 hours post-treatment

  • +2 more secondary outcomes

Study Arms (1)

Experimental Group

EXPERIMENTAL

Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System.

Device: Cerebrovascular Interventional Procedural Control System

Interventions

Cerebrovascular Interventional Procedural Control SystemDEVICE

The Cerebrovascular Interventional Procedural Control System is intended for use in the remote delivery and manipulation of guidewires and rapid deliver stent catheters, and remote manipulation of guide catheters during cerebrovascular intervention procedures.

Experimental Group

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80.
  • Diagnosed with acute ischemic stroke.
  • Arterial occlusion in the anterior cerebral circulation that was confirmed by CTA or MRA.
  • Subject could be treated intraarterially within 8 hours after symptom onset.
  • Prestroke Modified Rankin Score ≤ 1.
  • National Institutes of Health Stroke Scale (NIHSS) ≥6 and ≤20.
  • Patients or their legally authorised representatives provided signed, informed consent.

You may not qualify if:

  • NCCT ASPECT score \<6，or the infarct volume exceeded 1/3 of the middle cerebral artery blood supply area.
  • CT/MR Showed midline shift or cerebral hernia, and ventricle occupying effect. Intracranial hemorrhage. CTA/MRA shows carotid artery dissection, severe stenosis, or complete occlusion, which requiring carotid stent implantation during thrombectomy; Bilateral acute stroke or multiple intracranial large vessel occlusion.
  • Females who are pregnant or lactating.
  • Severe allergy to contrast agents, nickel-titanium metal or its alloys.
  • Drug-resistant hypertension (defined as sustained systolic blood pressure \>185mmHg or diastolic blood pressure \>110mmHg).
  • Hemorrhagic tendency (including but not limited to platelet \<100\*109/L, heparin treatment within 48 hours with APTT ≥35s, taking warfarin with an INR \> 1.7).
  • Surgery or biopsy of parenchymal organs within the last 1 month
  • Any active or recent bleeding (gastrointestinal, urinary, etc.) within the last 1 month
  • Undergoing hemodialysis or peritoneal dialysis; exist of severe renal insufficiency (serum creatinine \>220umol/L or 2.5mg/dl)
  • Previous intracranial hemorrhage, subarachnoid hemorrhage, brain tumor.
  • Life expectancy of less than 1 year.
  • Enrollment in another clinical trial evaluating other devices or drugs during the same period.
  • Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Vico Wang

CONTACT

+8657156105021neuroscience@dnamedtech.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

October 15, 2023

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

CN(1)