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NCT04195568 · ClinicalTrials.gov registry record · NA

Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System

A NA study of Aneurysm, Intracranial, sponsored by Stryker Neurovascular.

Active
Registry status
NA
Development phase
248
Enrollment target
20
Study locations

NCT04195568 is a NA study of Aneurysm, Intracranial that is active but no longer recruiting, run by Stryker Neurovascular. The registered enrollment target is 248 participants, above the 216-participant average among 3 other Aneurysm, Intracranial trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT04195568, a NA study of Aneurysm, Intracranial, is active but no longer recruiting, sponsored by Stryker Neurovascular.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
248 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches

Conditions Studied

Interventions

  • DEVICE Surpass Evolve Flow Diverter System

Study Locations (20)

Florida

  • Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery - Jacksonville
  • Mayo Clinic Florida - Jacksonville
  • Baptist Hospital of Miami - Miami
  • Tallahassee Neurological Clinic - Tallahassee

Massachusetts

  • Tufts Medical Center - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Lahey Clinic - Burlington
  • University of Massachusetts - North Worcester

Arizona

  • DIGNITY HEALTH/ Barrow Neurological Institute - Phoenix
  • St. Joseph's Hospital - Tucson

California

  • University of California, Los Angeles - Los Angeles

Illinois

  • Advocate Lutheran General Hospital - Park Ridge

Indiana

  • Indiana University - Indianapolis

Iowa

  • University of Iowa - Iowa City

Kansas

  • University of Kansas Medical Center - Kansas City

Trial Details

FieldValue
Enrollment Target 248 participants
Start Date 2020-07-07
Est. Completion 2028-09-13
Phase NA

Sponsor

Stryker Neurovascular

13 total trials

What the Registry Record Tells You About NCT04195568

The ClinicalTrials.gov registry entry for NCT04195568 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 216-participant average among 3 other Aneurysm, Intracranial trials with a reported enrollment target (15% higher). The listed sponsor is Stryker Neurovascular, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Aneurysm, Intracranial appearing as the primary indexed condition, and to 1 intervention - of which Surpass Evolve Flow Diverter System is the first listed.

NCT04195568 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Massachusetts, Arizona.

Frequently Asked Questions

What is clinical trial NCT04195568 about?

NCT04195568 is a clinical study titled "Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System". The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches

What is the current status of trial NCT04195568?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 248 participants. The study started on 2020-07-07. Estimated completion is 2028-09-13.

What conditions does trial NCT04195568 study?

This clinical trial studies the following conditions: Aneurysm, Intracranial.

What interventions are being tested in trial NCT04195568?

The interventions under investigation include: Surpass Evolve Flow Diverter System (DEVICE).

Who is sponsoring clinical trial NCT04195568?

This trial is sponsored by Stryker Neurovascular, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04195568 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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