Trial Outcomes & Findings for TransForm™ Occlusion Balloon Catheter Registry (NCT NCT01949779)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

81 participants

Primary outcome timeframe

intra-procedure

Results posted on

2019-09-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	TransForm OBC TransForm Occlusion Balloon Catheter
Overall Study STARTED	81
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TransForm™ Occlusion Balloon Catheter Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TransForm OBC n=81 Participants TransForm Occlusion Balloon Catheter
Age, Continuous	54.78 years STANDARD_DEVIATION 14.51 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants
Region of Enrollment Spain	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	TransForm™ OBC n=83 Catheters TransForm™ Occlusion Balloon Catheter
Catheters Visualized That Reached Intended Target	1.59 Catheters Standard Deviation 0.78

SECONDARY outcome

Timeframe: intra-procedure

Visibility of TransForm™ OBC on angiography

Outcome measures

Outcome measures
Measure	TransForm™ OBC n=83 Catheters TransForm™ Occlusion Balloon Catheter
Angiographic Assessment on Catheter	1.78 Catheters Standard Deviation 0.84

SECONDARY outcome

Timeframe: post-procedure

Ability of TransForm™ OBC to Perform as Intended

Outcome measures

Outcome measures
Measure	TransForm™ OBC n=81 Participants TransForm™ Occlusion Balloon Catheter
Procedural Technical Success	83 Catheters

Adverse Events

TransForm OBC

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TransForm OBC n=81 participants at risk TransForm Occlusion Balloon Catheter
Injury, poisoning and procedural complications Thromboembolic event	2.5% 2/81
Surgical and medical procedures Vessel rupture/perforation	1.2% 1/81

Other adverse events

Other adverse events
Measure	TransForm OBC n=81 participants at risk TransForm Occlusion Balloon Catheter
Surgical and medical procedures Thrombus formation	1.2% 1/81
Injury, poisoning and procedural complications Thrombus formation	1.2% 1/81

Additional Information

Cheryl Fontana, Sr. Manager, Clinical Services

Stryker Neurovascular

Phone: 510-413-2948

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60