Trial Outcomes & Findings for Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device (NCT NCT03637374)
NCT ID: NCT03637374
Last Updated: 2022-08-19
Results Overview
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
30 days
Results posted on
2022-08-19
Participant Flow
Participant milestones
| Measure |
Primary Study Arm
The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
Expanded Selection Arm
The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Primary Study Arm
The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
Expanded Selection Arm
The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
Baseline Characteristics
Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device
Baseline characteristics by cohort
| Measure |
Primary Study Arm
n=2 Participants
The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
Expanded Selection Arm
The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Enrolled patients with non-staged, completed procedures were analyzed.
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Outcome measures
| Measure |
Primary Study Arm
n=2 Participants
The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
Expanded Selection Arm
The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
|---|---|---|
|
Freedom From Major Adverse Events (MAEs) at 30 Days
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Enrolled patients with non-staged, completed procedures were analyzed.
Treatment success is defined as a composite of technical success and freedom from the following: Aneurysm enlargement, Aneurysm rupture, Aneurysm-related mortality, Conversion to open repair, Secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events.
Outcome measures
| Measure |
Primary Study Arm
n=2 Participants
The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
Expanded Selection Arm
The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
|---|---|---|
|
Treatment Success at 1 Year
|
0 Participants
|
0 Participants
|
Adverse Events
Primary Study Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths
Expanded Selection Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Study Arm
n=2 participants at risk
The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
Expanded Selection Arm
The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation and the unitary manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Visceral Manifold and Thoracic Bifurcation: Endovascular stent graft system
Unitary Manifold: Endovascular stent graft system
TAAA Debranching Stent Graft System: Endovascular stent graft system
|
|---|---|---|
|
Gastrointestinal disorders
bowel ischemia
|
50.0%
1/2 • Number of events 1 • 1 year
Enrolled patients who received the study intervention were monitored and evaluated for Major Adverse Events (MAEs) and Serious Adverse Events (SAEs).
|
—
0/0 • 1 year
Enrolled patients who received the study intervention were monitored and evaluated for Major Adverse Events (MAEs) and Serious Adverse Events (SAEs).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place