NCT02533778

Brief Summary

A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

Study Start

First participant enrolled

July 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 2, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

July 14, 2015

Last Update Submit

July 31, 2017

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Thrombolysis in Cerebral Infarction (TICI) score

    6 months

Secondary Outcomes (3)

  • National Institutes of Health Stroke Scale (NIHSS) score

    6 months

  • Montreal Cognitive Assessment (MoCA) tool

    6 months

  • Modified Rankin Scale

    6 months

Study Arms (1)

Interventional mechanical thrombectomy

EXPERIMENTAL

Mechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device for acute stroke symptom onset between 8 - 24 hours

Device: mechanical thrombectomy

Interventions

mechanical thrombectomyDEVICE

Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device

Also known as: Penumbra system, TREVO, Solitaire
Interventional mechanical thrombectomy

Eligibility Criteria

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

You may qualify if:

  • Over 18 years last seen normal between 8 - 24 hours, without prior history of intravenous plasminogen activator (IV t-PA ) or
  • mechanical thrombectomy Vessels - intracranial vertebral artery, basilar artery, intracranial ICA, ICA terminus bifurcation, MCA M1/M2, or
  • ACA NIHSS ≥ 7 MRI DWI/PWI or
  • CTA/P, which demonstrates an area of mismatch ≥ 2/3 rd
  • Signed informed consent

You may not qualify if:

  • creat \>= 2
  • NIHSS \< 7
  • Baseline mRS \>= 2
  • infarct \> 1/3rd MCA territory
  • competing trials
  • prior IV or IA treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Qaisar Shah, MD

    Abington Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: with control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBA CRNP

Study Record Dates

First Submitted

July 14, 2015

First Posted

August 27, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 2, 2017

Record last verified: 2017-07

Locations

US(1)