TransForm™ Occlusion Balloon Catheter Registry

Stryker

Status: Completed

Conditions: Intracranial Aneurysms

Treatments: Device: TransForm™ Occlusion Balloon Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT01949779

T4023

Details and patient eligibility

About

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

Full description

• 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

81 participants in 1 patient group

TransForm™ Occlusion Balloon Catheter

Description:

TransForm™ Occlusion Balloon Catheter

Treatment:

Device: TransForm™ Occlusion Balloon Catheter