Intracranial Aneurysms
Conditions
Keywords
Coil embolization, TransForm™ Occlusion Balloon Catheter, Registry, Neurointerventional procedures
Brief summary
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
Detailed 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.
Interventions
DEVICETransForm™ Occlusion Balloon Catheter
TransForm™ Occlusion Balloon Catheter
Sponsors
Stryker Neurovascular
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheters Visualized That Reached Intended Target | intra-procedure | The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic Assessment on Catheter | intra-procedure | Visibility of TransForm™ OBC on angiography |
| Procedural Technical Success | post-procedure | Ability of TransForm™ OBC to Perform as Intended |
Countries
Spain, United States
Participant flow
Recruitment details
Enrollment occurred over 13 months at 7 sites in the US and 1 site in Spain. Each site was allowed to enroll up to 20 consecutive subjects. The first subject was enrolled on 12 December 2013 and the enrollment was completed on 12 January 2015. A total of 81 subjects were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| TransForm OBC TransForm Occlusion Balloon Catheter | 81 |
| Total | 81 |
Baseline characteristics
| Characteristic | TransForm OBC |
|---|---|
| Age, Continuous | 54.78 years STANDARD_DEVIATION 14.51 |
| Region of Enrollment Spain | 15 participants |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 81 |
| serious Total, serious adverse events | 3 / 81 |
Outcome results
Primary
Catheters Visualized That Reached Intended Target
The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.
Time frame: intra-procedure
Population: The number of catheters exceeds the number of participants enrolled, as more than one catheter may have been used for each participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TransForm™ OBC | Catheters Visualized That Reached Intended Target | 1.59 Catheters | Standard Deviation 0.78 |
Secondary
Angiographic Assessment on Catheter
Visibility of TransForm™ OBC on angiography
Time frame: intra-procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TransForm™ OBC | Angiographic Assessment on Catheter | 1.78 Catheters | Standard Deviation 0.84 |
Secondary
Procedural Technical Success
Ability of TransForm™ OBC to Perform as Intended
Time frame: post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TransForm™ OBC | Procedural Technical Success | 83 Catheters |