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Trial record 1 of 1 for:    CLP 13669
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Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities (SURF)

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ClinicalTrials.gov Identifier: NCT04106583
Recruitment Status : Active, not recruiting
First Posted : September 27, 2019
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Brief Summary:
The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.

Condition or disease Intervention/treatment
Aneurysm, Brain Device: WAVE, as part of the SMART COIL System

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Study Type : Observational
Actual Enrollment : 575 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms Using WAVE™ Extra Soft Coils, a Part of the Penumbra SMART COIL® System
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Single Arm
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
Device: WAVE, as part of the SMART COIL System
WAVE, as part of the SMART COIL System




Primary Outcome Measures :
  1. Efficacy: Adequate Occlusion [ Time Frame: Through Study Completion, An Average of 1 Year ]

    Adequate occlusion defined as Raymond-Roy Class I and II at final follow-up

    Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.


  2. Safety: Serious Adverse Events (SAEs) [ Time Frame: Up to 24 Hours Post-Procedure ]
    SAEs within 24 hours post-procedure

  3. Safety: Device-Related SAE [ Time Frame: Through Discharge, up to 7 Days Post-Procedure ]
    Device-related SAE up to 7 days or discharge


Secondary Outcome Measures :
  1. Efficacy: Occlusion rate [ Time Frame: Immediate Post-Procedure ]
    Immediate post-procedure occlusion rates

  2. Efficacy: Retreatment Rate [ Time Frame: Through Study Completion, An Average of 1 Year ]
    Retreatment rate at final follow-up

  3. Efficacy: Aneurysm Occlusion Raymond I [ Time Frame: Immediate Post-Treatment ]
    Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.

  4. Efficacy: Aneurysm Occlusion Raymond I [ Time Frame: Through Study Completion, An Average of 1 Year ]
    Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.

  5. Efficacy: Aneurysm Recanalization or Progressive Thrombosis [ Time Frame: From Immediate Post Procedure Through Study Completion, An Average of 1 Year ]
    Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up

  6. Safety: Major Ipsilateral Stroke [ Time Frame: Through Study Completion, An Average of 1 Year ]
    Occurrence of Major Ipsilateral Stroke

  7. Safety: Device-Related SAE [ Time Frame: Through Study Completion, An Average of 1 Year ]
    Device related SAE at final follow-up

  8. Safety: All-cause Morbidity and Mortality [ Time Frame: Through Study Completion, An Average of 1 Year ]
    All-cause morbidity and mortality at final follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
Criteria

Inclusion Criteria:

  • Patient age ≥ 18 years
  • Patient having embolization of intracranial aneurysms
  • WAVE Extra Soft Coil is final finishing coil
  • Penumbra SMART COIL System accounts for at least 75% of total number of coils implanted
  • Informed consent obtained per IRB/EC requirements

Exclusion Criteria:

  • Life expectancy less than 1 year
  • Patient previously enrolled in the SURF Study
  • Known multiple intracranial aneurysms requiring treatment during index procedure
  • Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
  • Participation in an interventional drug or device study that may confound the results of the study

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): NCT04106583


Locations
Show Show 44 study locations
Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: Clemens M Schirmer, MD Geisinger Clinic
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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT04106583    
Other Study ID Numbers: CLP 13669
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
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