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Thrombolytic Agent

Stent-retriever thrombectomy with revascularization device of the Solitaire™ type for Ischemic Stroke (SWIFT DIRECT Trial)

N/A

Waitlist Available

Led By Urs Fischer, Prof. Dr.

Research Sponsored by University Hospital Inselspital, Berne

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days after randomization

Awards & highlights

SWIFT DIRECT Trial Summary

This trial is testing whether a new treatment for stroke is as effective as the current standard of care. The new treatment is direct mechanical thrombectomy, which is a minimally invasive procedure to remove a blood clot. The standard of care is intravenous thrombolysis with recombinant tissue-type plasminogen activator, which is a medication that breaks up blood clots.

Eligible Conditions

Ischemic Stroke
Stroke

SWIFT DIRECT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Score in modified Rankin Scale (mRS)

Secondary outcome measures

Intracranial hemorrhage

Modified Rankin Scale (mRS) shift analysis

Mortality

+5 more

SWIFT DIRECT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Direct mechanical thrombectomyExperimental Treatment1 Intervention

Treatment with direct mechanical thrombectomy with a commercially available stent-retriever revascularization device of the Solitaire™ type.

Group II: Combined intravenous thrombolysis and mechanical thrombectomyActive Control2 Interventions

Treatment with intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) followed by mechanical thrombectomy with a commercially available stent-retriever revascularization device of the Solitaire™ type.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stent-retriever thrombectomy with revascularization device of the Solitaire™ type

2017

N/A

~410

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Hospital Inselspital, BerneLead Sponsor

721 Previous Clinical Trials

2,254,064 Total Patients Enrolled

9 Trials studying Ischemic Stroke

6,774 Patients Enrolled for Ischemic Stroke

Insel Gruppe AG, University Hospital BernLead Sponsor

769 Previous Clinical Trials

1,810,173 Total Patients Enrolled

12 Trials studying Ischemic Stroke

8,308 Patients Enrolled for Ischemic Stroke

MedtronicIndustry Sponsor

606 Previous Clinical Trials

828,255 Total Patients Enrolled

5 Trials studying Ischemic Stroke

3,437 Patients Enrolled for Ischemic Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the inaugural trial of its type?

"Since 2017, research has been conducted on the efficacy of Stent-retriever thrombectomy with revascularization device of the Solitaire™ type. The first trial was funded by Medtronic and included 410 participants. Subsequent studies received a N/A drug approval from regulatory bodies, resulting in 4 ongoing trials spanning 61 cities across 9 countries."

Answered by AI

To what extent has the utilization of Solitaire™-type revascularization devices in conjunction with Stent-retriever thrombectomy been explored by prior research?

"Currently, 4 clinical trials for the Solitaire™ type of stent-retriever thrombectomy with revascularization device have reached Phase 3. 111 medical centres across the world (with a majority in St. John's, Newfoundland and Labrador) are carrying out studies on this therapeutic technique."

Answered by AI

How many participants are engaged in the experiment?

"Unfortunately, this research project has concluded participant recruitment. It was initially posted on the 29th of November 2017 and last modified on 21st May 2021. Nevertheless, there are still 1324 studies for wake-up stroke actively recruiting as well as 4 trials concerning Stent-retriever thrombectomy with revascularization device of Solitaire™ type taking in patients."

Answered by AI

Is recruitment for the trial still underway?

"Unfortunately, this experiment is no longer recruiting participants. It was initially added to the database on November 29th 2017 and last edited on May 21st 2021. However, there are 1324 studies similarly related to wake-up stroke currently enrolling patients as well as 4 trials that concern Stent-retriever thrombectomy with revascularization device of the Solitaire™ type which are still seeking volunteers for evaluation."

Answered by AI

Are there any US-based sites currently administering this research project?

"This study is enlisting patients from several Canadian locations, such as McGill University in Montréal, Toronto Western Hospital in Toronto and University of Calgary with Alberta Health Services in Calgary. Additionally, there are 4 other sites that are participating."

Answered by AI

Recent research and studies

International Journal of StrokeJournal

SWIFT DIRECT: Solitaire™ with the Intention for Thrombectomy Plus Intravenous T-pa Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke: Methodology of a Randomized, Controlled, Multicentre Study

Fischer, Urs, Johannes Kaesmacher, Patricia S Plattner, Lukas Bütikofer, Pasquale Mordasini, Sandro Deppeler, Christoph Cognard, et al.. 2021. “SWIFT DIRECT: Solitaire™ with the Intention for Thrombectomy Plus Intravenous T-pa Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke: Methodology of a Randomized, Controlled, Multicentre Study”. International Journal of Stroke. SAGE Publications. doi:10.1177/17474930211048768.

International Journal of StrokeJournal

The LancetJournal

Thrombectomy Alone Versus Intravenous Alteplase Plus Thrombectomy in Patients with Stroke: An Open-label, Blinded-outcome, Randomised Non-inferiority Trial

Fischer, Urs, Johannes Kaesmacher, Daniel Strbian, Omer Eker, Christoph Cognard, Patricia S Plattner, Lukas Bütikofer, et al.. 2022. “Thrombectomy Alone Versus Intravenous Alteplase Plus Thrombectomy in Patients with Stroke: An Open-label, Blinded-outcome, Randomised Non-inferiority Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(22)00537-2.