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POSITIVE Stroke Clinical Trial

NCT01852201 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-11-13

Study results available
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Summary

Primary Endpoint:

The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT with respect to endpoint defined as:

• 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw mRS scores. Statistical details can be found in section 7.2.

Secondary Endpoints:

* 90-day global disability in the 6-12 hr cohort assessed via the overall distribution of mRS
* Proportion of patients with good functional recovery for the 6-12 hr cohort as defined by mRS 0-2 at 90 days
* Mortality at 30 and 90 days
* Intracranial hemorrhage with neurological deterioration (NIHSS worsening \>4) within 24 hours of randomization
* Procedure related serious adverse events (SAE's)
* Arterial revascularization measured by TICI 2b or 3 following device use

Conditions

Interventions

DEVICE

Endovascular Mechanical Thrombectomy

Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.

Sponsors & Collaborators

  • Vanderbilt University

    collaborator OTHER

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Jonathan Lena, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852201 on ClinicalTrials.gov