NCT03144960

Brief Summary

Assessment of Therapeutic benefits and hazards of Mechanical Thrombectomy in Ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

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

April 17, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

April 17, 2017

Last Update Submit

May 4, 2017

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

  • Treatment Of Acute Occlusion In Ischemic Stroke by Mechanical Thrombectomy

    Treatment of ischemic stroke patients after 4.5 hours from stroke onset by endovascular intervention by using Mechanical Thrombectomy techniques and without using Recombinant tissue-type plasminogen Activator and non eligible patients for Thrombectomy will be excluded. The number of people will be participated into this study will be 20 aged 18 to 80 years old The patients will be undergoing NIHSS score , ASPECTS score The patients will be undergoing CT/CT angiography The patients will be undergoing mechanical thrombectomy Results will be collected and correlated with the prognosis of the outcomes

    18 months

Secondary Outcomes (3)

  • The patients will be undergoing NIHSS score

    1 hour

  • The patients will be undergoing ASPECTS score

    1 hour

  • The patients will be undergoing CT/CT angiography

    2 hours

Study Arms (1)

mechanical thrombectomy

OTHER

The study will be performed involving ischemic stroke patients with proximal occlusion within 4.5 hours from stroke onset, mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption.

Procedure: Mechanical Thrombectomy

Interventions

Mechanical ThrombectomyPROCEDURE

mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption

mechanical thrombectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 - 80 years old of both sex.
  • Acute ischemic stroke due to proved large-artery occlusion.
  • Ineligibility for IV thrombolysis.
  • A timeframe of ≤ 4.5 hours between stroke onset and the start of mechanical thrombectomy.
  • The patients included in this series should have an NIHSS score of at least 10 or fluctuating symptoms.
  • ASPECTS of 6 or \> 6
  • All patients will be undergoing CT/CT angiography before and after treatment

You may not qualify if:

  • Age older than 80 years or less than 18
  • Cerebral haemorrhage.
  • Acute infarction \> 1/3 of middle cerebral artery (MCA) territory on CT-scan.
  • A history of stroke in the last 6 weeks.
  • A time interval of \> 4.5 hours.
  • laboratory evidence of coagulation abnormalities.
  • Known arteriovenous malformation , neoplasm or aneurysm.
  • Woman at child bearing age who has a positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G; SITS-MOST investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007 Jan 27;369(9558):275-82. doi: 10.1016/S0140-6736(07)60149-4.

    PMID: 17258667RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Eman Khedr, Professor

CONTACT

+201005850632emankhedr99@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 17, 2017

First Posted

May 9, 2017

Study Start

November 1, 2017

Primary Completion

November 1, 2018

Study Completion

December 1, 2019

Last Updated

May 9, 2017

Record last verified: 2017-05