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Completed

NCT Number: NCT01949779

TransForm™ Occlusion Balloon Catheter Registry

The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures

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Key information

Conditions

Intracranial Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Donostia, Donostia / San Sebastian, Spain

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About this study

  • This is a prospective, single-arm, non-randomized, multi-center, observational registry.
  • The expected duration for study enrollment is approximately 6 months-1 year.
  • Study participation for each subject will be completed upon removal of the guide catheter post-procedure.
  • Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects.
  • Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject or legal representative is willing and has provided informed consent.
  • Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
  • Subject is over 18 years of age.

Exclusion criteria

  • Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
  • Subject's pregnant

Treatment and study plan

TransForm™ Occlusion Balloon Catheter

Device

TransForm™ Occlusion Balloon Catheter

Primary outcomes

  1. Catheters Visualized That Reached Intended Target

    Time frame: intra-procedure

    The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.

Secondary outcomes

  1. Angiographic Assessment on Catheter

    Time frame: intra-procedure

    Visibility of TransForm™ OBC on angiography

  2. Procedural Technical Success

    Time frame: post-procedure

    Ability of TransForm™ OBC to Perform as Intended

Sponsors and collaborators

Lead sponsor

Stryker Neurovascular

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2013
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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