Trial Outcomes & Findings for 3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization (NCT NCT03164629)

Results Overview

For the cases using Emboguide this will be measured as the time from which the Emboguide is displayed on the live fluoroscopy to the time of prostatic artery catheterization. Emboguide display is in addition to the angiogram roadmap display. For the control cases this will be measured as the time from which the angiogram is displayed on the live fluoroscopy to the time of prostatic artery catheterization.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

hour 2

Results posted on

2019-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	3D Angiogram + Emboguide The following parameters will be recorded for the study group: Participants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.	No 3D Angiogram + Emboguide Embolization will be guided by a standard of care CT.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3D Angiogram + Emboguide n=25 Participants Participants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.	No 3D Angiogram + Emboguide n=25 Participants Embolization will be guided by a standard of care CT.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=25 Participants	12 Participants n=25 Participants	26 Participants n=50 Participants
Age, Categorical >=65 years	11 Participants n=25 Participants	13 Participants n=25 Participants	24 Participants n=50 Participants
Sex: Female, Male Female	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Sex: Female, Male Male	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: hour 2

Population: at times unable to catheterize the participants arteries

For the cases using Emboguide this will be measured as the time from which the Emboguide is displayed on the live fluoroscopy to the time of prostatic artery catheterization. Emboguide display is in addition to the angiogram roadmap display. For the control cases this will be measured as the time from which the angiogram is displayed on the live fluoroscopy to the time of prostatic artery catheterization.

Outcome measures

Outcome measures
Measure	3D Angiogram + Emboguide n=25 Participants Participants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.	No 3D Angiogram + Emboguide n=25 Participants Embolization will be guided by a standard of care CT.
Time for Prostatic Artery Catheterization Right Artery	273.40 seconds Standard Deviation 406.64	181.71 seconds Standard Deviation 185.11
Time for Prostatic Artery Catheterization Left Artery	206.38 seconds Standard Deviation 228.96	155.96 seconds Standard Deviation 216.32

Adverse Events

3D Angiogram + Emboguide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No 3D Angiogram + Emboguide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shivank Bhatia, MD

University of Miami

Phone: 305-585-7500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place