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Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281721
Recruitment Status : Active, not recruiting
First Posted : November 2, 2014
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Brief Summary:
The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.

Condition or disease Intervention/treatment
Cerebral Aneurysm Device: Surpass Flow Diverter(s)

Detailed Description:
This will be a prospective, observational, multi-center, single-arm, post-marketing, international registry with consecutive enrollment of a minimum of 150 patients treated with the Surpass Flow Diverter in accordance with the standard of care at up to 30 registry sites.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective, Observational, Multi-Center, Single-Arm, Consecutive Enrollment, Post-Marketing, International Registry of the Surpass™ Flow Diverter in Intracranial Arteries
Actual Study Start Date : March 18, 2015
Actual Primary Completion Date : December 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Single Group; Surpass Flow Diverter(s)
Individuals using the Surpass Flow Diverter(s)
Device: Surpass Flow Diverter(s)
Endovascular placement of a Surpass Flow Diverter(s) for the treatment of an intracranial aneurysm(s)




Primary Outcome Measures :
  1. Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion [ Time Frame: 12 months ]
    The proportion of patients with 100% aneurysm occlusion, based on an assessment of each patient's imaging at 12 months (± 180 days) post-procedure, and stratified across four aneurysm categories.


Secondary Outcome Measures :
  1. Technical success assessed by deployment of the device with complete coverage of the aneurysm neck [ Time Frame: Peri-procedural ]
    Successful deployment of the device with complete coverage of the aneurysm neck.


Other Outcome Measures:
  1. Safety outcomes assessed by neurological adverse events [ Time Frame: Up to 5 years ]
    Neurological adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
For the primary endpoint, the evaluable patient population will consist of all individuals treated with the Surpass Flow Diverter(s) who have provided consent, and who have completed their 12 month follow-up assessment.
Criteria

Inclusion Criteria:

  • Patients who are to be treated with a Surpass Flow Diverter(s) will be eligible to participate in this registry. Patients will be enrolled on a consecutive basis.

Exclusion Criteria:

  • This is a standard of care registry. Patients should be excluded if standard of care at a given site is such that they are not eligible for treatment with a Surpass Flow Diverter(s).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281721


Locations
Show Show 19 study locations
Sponsors and Collaborators
Stryker Neurovascular
Investigators
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Principal Investigator: Patrick A Brouwer, MD Karolinska Hospital
Additional Information:

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Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02281721    
Other Study ID Numbers: T4029
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents