Trial Outcomes & Findings for Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms (NCT NCT03113383)

Results Overview

Freedom from major adverse events (MAE) at 30 days.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

30 days

Results posted on

2022-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Primary Arm Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.	Experimental: Expanded Selection Arm Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
Overall Study STARTED	4	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Primary Arm Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.	Experimental: Expanded Selection Arm Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
Overall Study Death	4	0

Baseline Characteristics

Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Primary Arm n=4 Participants Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: No data was collected.

Freedom from major adverse events (MAE) at 30 days.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Data was not collected.

Proportion of subjects treated with the device that achieve and maintain treatment success at 1 year.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected.

Freedom from major adverse events (MAE) at 6 Months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year.

Population: No data collected

Freedom from major adverse events (MAE) at 1 year.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years.

Population: No data collected

Freedom from major adverse events (MAE) at 2 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years.

Population: No data collected

Freedom from major adverse events (MAE) at 3 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years.

Population: No data collected

Freedom from major adverse events (MAE) at 4 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years.

Population: Data were not collected at this time point as the study was terminated before 5 years

Freedom from major adverse events (MAE) at 5 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days.

Population: No participants enrolled in the Expanded Selection Arm

Proportion of subjects treated with the device that achieve and maintain treatment success at 30 days as defined by aneurysm exclusion.

Outcome measures

Outcome measures
Measure	Primary Arm n=4 Participants Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. Thoracoabdominal Aortic Aneurysm Repair: Thoracoabdominal aortic aneurysm repair	Expanded Selection Arm Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. Thoracoabdominal Aortic Aneurysm Repair: Thoracoabdominal aortic aneurysm repair
Secondary Effectiveness Assessment	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months.

Population: There were no patients alive at 6 months. No data was collected.

Proportion of subjects treated with the device that achieve and maintain treatment success at 6 months as defined by aneurysm exclusion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years.

Population: There were no patients alive at 2 years. No data was collected.

Proportion of subjects treated with the device that achieve and maintain treatment success at 2 years as defined by aneurysm exclusion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years.

Population: There were no patients alive at 3 years. No data was collected.

Proportion of subjects treated with the device that achieve and maintain treatment success at 3 years as defined by aneurysm exclusion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years.

Population: There were no patients alive at 4 years. No data was collected.

Proportion of subjects treated with the device that achieve and maintain treatment success at 4 years as define by aneurysm exclusion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years.

Population: There were no patients alive at 5 years. No data was collected.

Proportion of subjects treated with the device that achieve and maintain treatment success at 5 years as define by aneurysm exclusion.

Outcome measures

Outcome data not reported

Adverse Events

Experimental: Primary Arm

Serious events: 4 serious events

Other events: 0 other events

Deaths: 4 deaths

Experimental: Expanded Selection Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental: Primary Arm n=4 participants at risk Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.	Experimental: Expanded Selection Arm Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.
General disorders Multi-organ failure -	50.0% 2/4 • Number of events 2 • 4 Years and 2 months Adverse events were assessed from enrollment until 30 days after procedure. All-Cause Mortality was from date of procedure up to 4 years and 2 months	— 0/0 • 4 Years and 2 months Adverse events were assessed from enrollment until 30 days after procedure. All-Cause Mortality was from date of procedure up to 4 years and 2 months
Nervous system disorders Stroke	25.0% 1/4 • Number of events 1 • 4 Years and 2 months Adverse events were assessed from enrollment until 30 days after procedure. All-Cause Mortality was from date of procedure up to 4 years and 2 months	— 0/0 • 4 Years and 2 months Adverse events were assessed from enrollment until 30 days after procedure. All-Cause Mortality was from date of procedure up to 4 years and 2 months
Cardiac disorders Cardiac Arrest	25.0% 1/4 • Number of events 1 • 4 Years and 2 months Adverse events were assessed from enrollment until 30 days after procedure. All-Cause Mortality was from date of procedure up to 4 years and 2 months	— 0/0 • 4 Years and 2 months Adverse events were assessed from enrollment until 30 days after procedure. All-Cause Mortality was from date of procedure up to 4 years and 2 months

Other adverse events

Adverse event data not reported

Additional Information

Thomas C Naslund, MD

Vanderbilt University Medical Center

Phone: 5-322-2343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place