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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 3, 2014
Last Update Posted : February 15, 2019
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
Study Start Date : March 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2024

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

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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
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Belgium
AZ groeninge
Kortrijk, Belgium, 8500
Finland
Helsinki University Hospital
Helsinki, Finland, 00260
Turun yliopistollinen keskussairaala
Turku, Finland, 20521
France
Hopital Jean Minjoz
Besançon, France, 25030
APHP - Kremlin Bicêtre
Le Kremlin-Bicêtre, France, 94270
Fondation Rothschild
Paris, France, 75020
Hopital Bretonneau
Tours, France, 37 000
Germany
Freiburg University Hospital
Freiburg, Germany, 79085
Klinikum Kassel
Kassel, Germany, 34125
Universitätsmedizin Mannheim
Mannheim, Germany, 68167
Italy
San Martino Hospital
Genova, Italy, 16132
Neuroradiologia Azienda ILSS9
Treviso, Italy, 31100
Netherlands
Radboudumc
Nijmegen, Netherlands, 6500
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Sweden
Karolinska University Hospital in Solna, Department of Neuroradiology
Stockholm, Sweden, 171 16
United Kingdom
Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust
Romford, Essex, United Kingdom, RM7 0AG
Queen Elizabeth Hospital
Birmingham, United Kingdom
The Walton center
Liverpool, United Kingdom, L9 7LJ
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     History of Changes
Other Study ID Numbers: T4029
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents