INCA: Intracranial Aneurysm Treatment With NeXsys (INCA)

January 29, 2019 updated by: Cerus Endovascular, Ltd
Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Prospective, single center first-in-man study of use of device for intracranial aneurysm occlusion. Target aneurysms are small unruptured aneurysms in the anterior and posterior circulation.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1428ARJ
        • Instituto Clinico ENERI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-80 years at screening
  • Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
  • IA appears suitable for NeXsys device
  • Patient willing to comply with study requirements
  • Patient able to understand and sign a study-specific informed consent form

Exclusion Criteria:

  • Ruptured IA
  • Any other IA that requires treatment in the next year
  • IA width >10 mm
  • IA neck >9 mm
  • IA has important flow from its base such that occluding the IA would cause stroke
  • Target IA contains any device (e.g., coils)
  • Inability to access the target IA with microcatheter
  • Any congenital or iatrogenic coagulopathy
  • Platelet count <50,000/microliter
  • Known allergy to platinum, nickel or titanium
  • Known allergy to contrast agents
  • Stenosis of the target IA's parent vessel >50%
  • Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent)
  • Taking any anticoagulants (e.g., warfarin)
  • Pregnant or planning pregnancy in the next 2 years
  • Other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.)
  • Participating in another study with investigational devices or drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Placement of study device (currently called NeXsys) into target aneurysm via standard endovascular procedure.
Device: NeXsys Embolization System
Woven metallic mesh placed in aneurysm fundus
Other Names:
  • Contour Neurovascular System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: occurrence of major ipsilateral stroke or neurologic death
Time Frame: 3-6 months
3-6 months
Ability of the investigator to place the device in an acceptable position in the target IA, judged at the time of placement, with no migration or change in position of the device at 3-6 month angiogram.
Time Frame: 3-6 mo
3-6 mo

Secondary Outcome Measures

Outcome Measure
Time Frame
Occlusion status of the target IA at 30 days, 3-6 months, 1 year and 5 years as judged by an independent physician using the Raymond classification system.
Time Frame: 30 days, 3-6 months, 1 year and 5 years
30 days, 3-6 months, 1 year and 5 years
Occurrence rate of any neurologic or vascular adverse event related to the target IA or device placement procedure
Time Frame: Beginning of index procedure to end of index procedure (approximately 1 hour, maximum 3 hours)
Beginning of index procedure to end of index procedure (approximately 1 hour, maximum 3 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerus Endovascular, Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

January 8, 2019

Study Completion (Actual)

January 8, 2019

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNX-041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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