TransForm™ Occlusion Balloon Catheter Registry

• Sponsor: Stryker Neurovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01949779
• Collaborator: (none)
• Enrollment: 81
• Locations: 7
• Duration (Months): 13
• Patients Per Site: 11.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysms	Device: TransForm™ Occlusion Balloon Catheter

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 81 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: TransForm™ Occlusion Balloon Catheter Registry
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
TransForm™ Occlusion Balloon Catheter TransForm™ Occlusion Balloon Catheter	Device: TransForm™ Occlusion Balloon Catheter; TransForm™ Occlusion Balloon Catheter

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Angiographic Assessment on Catheter [intra-procedure]

   Visibility of TransForm™ OBC on angiography

2. Procedural Technical Success [post-procedure]

   Ability of TransForm™ OBC to Perform as Intended

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Desert Regional Medical Center	Palm Springs	California	United States	92262
2	Central Baptist Hospital	Lexington	Kentucky	United States	40503
3	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
4	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
5	West Virginia University	Morgantown	West Virginia	United States	26505
6	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
7	Hospital Universitario Donostia	San Sebastian		Spain

Sponsors and Collaborators

• Stryker Neurovascular

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Neurovascular
• ClinicalTrials.gov Identifier: NCT01949779
• Other Study ID Numbers: T4023
• First Posted: Sep 25, 2013
• Last Update Posted: Sep 6, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Stryker Neurovascular: Coil embolization; TransForm™ Occlusion Balloon Catheter; Registry; Neurointerventional procedures
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

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.

Arm/Group Title	TransForm OBC
Arm/Group Description	TransForm Occlusion Balloon Catheter
Period Title: Overall Study
STARTED	81
COMPLETED	79
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	TransForm OBC
Arm/Group Description	TransForm Occlusion Balloon Catheter
Overall Participants	81
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.78 (14.51)
Sex: Female, Male (Count of Participants)
Female	56 69.1%
Male	25 30.9%
Region of Enrollment (participants) [Number]
United States	66 81.5%
Spain	15 18.5%

Outcome Measures

1. Primary Outcome

Title	Catheters Visualized That Reached Intended Target
Description	The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.
Time Frame	intra-procedure

Outcome Measure Data

Analysis Population Description

The number of catheters exceeds the number of participants enrolled, as more than one catheter may have been used for each participant.

Arm/Group Title	TransForm™ OBC
Arm/Group Description	TransForm™ Occlusion Balloon Catheter
Measure Participants	81
Measure Catheters	83
Mean (Standard Deviation) [Catheters]	1.59 (0.78)

2. Secondary Outcome

Title	Angiographic Assessment on Catheter
Description	Visibility of TransForm™ OBC on angiography
Time Frame	intra-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TransForm™ OBC
Arm/Group Description	TransForm™ Occlusion Balloon Catheter
Measure Participants	81
Measure Catheters	83
Mean (Standard Deviation) [Catheters]	1.78 (0.84)

3. Secondary Outcome

Title	Procedural Technical Success
Description	Ability of TransForm™ OBC to Perform as Intended
Time Frame	post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TransForm™ OBC
Arm/Group Description	TransForm™ Occlusion Balloon Catheter
Measure Participants	81
Number [Catheters]	83

Adverse Events

Arm/Group Title	TransForm OBC
Arm/Group Description	TransForm Occlusion Balloon Catheter
All Cause Mortality
	TransForm OBC
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	TransForm OBC
	Affected / at Risk (%)	# Events
Total	3/81 (3.7%)
Injury, poisoning and procedural complications
Thromboembolic event	2/81 (2.5%)
Surgical and medical procedures
Vessel rupture/perforation	1/81 (1.2%)
Other (Not Including Serious) Adverse Events
	TransForm OBC
	Affected / at Risk (%)	# Events
Total	2/81 (2.5%)
Injury, poisoning and procedural complications
Thrombus formation	1/81 (1.2%)
Surgical and medical procedures
Thrombus formation	1/81 (1.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.