Trial Outcomes & Findings for Zenith® p-Branch® Endovascular Graft Pivotal Study (NCT NCT02396199)
NCT ID: NCT02396199
Last Updated: 2025-02-19
Results Overview
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
12 months
Results posted on
2025-02-19
Participant Flow
Participant milestones
| Measure |
Endovascular
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
Started 6-Month
|
79
|
|
Overall Study
Completed 6-Month
|
76
|
|
Overall Study
Started 12-Month
|
76
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Endovascular
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
One participant had an unreported race/ethnicity
Baseline characteristics by cohort
| Measure |
Endovascular
n=80 Participants
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Age, Continuous
|
71.7 years
STANDARD_DEVIATION 7.6 • n=80 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Black(origins of Africa)
|
7 Participants
n=79 Participants • One participant had an unreported race/ethnicity
|
|
Race/Ethnicity, Customized
White(origins of Europe, Middle East, or North Africa)
|
72 Participants
n=79 Participants • One participant had an unreported race/ethnicity
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Eight patients had incomplete outcome data either due to death, loss to follow-up, missed visits, or any combination thereof.
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
Outcome measures
| Measure |
Endovascular
n=72 Participants
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Treatment Success Proportion
|
0.917 Proportion of participants
Interval 0.827 to 0.969
|
Adverse Events
Endovascular
Serious events: 25 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Endovascular
n=80 participants at risk
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert and guide the study device(s) into place in the aorta.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
2/80 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
2.5%
2/80 • Number of events 2 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial ischaemia
|
2.5%
2/80 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Haematochezia
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Melaena
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
General disorders
Asthenia
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
General disorders
Stent-graft endoleak
|
3.8%
3/80 • Number of events 3 • 1 year
|
|
General disorders
Vascular stent occlusion
|
7.5%
6/80 • Number of events 7 • 1 year
|
|
General disorders
Vascular stent stenosis
|
2.5%
2/80 • Number of events 2 • 1 year
|
|
General disorders
Vascular stent thrombosis
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.2%
1/80 • Number of events 2 • 1 year
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Investigations
Oxygen saturation decreased
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Mental status changes
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal artery occlusion
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal infarct
|
2.5%
2/80 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Renal mass
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Debridement
|
1.2%
1/80 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral artery aneurysm
|
1.2%
1/80 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Endovascular
n=80 participants at risk
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents: Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert and guide the study device(s) into place in the aorta.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
4/80 • Number of events 4 • 1 year
|
|
General disorders
Stent-graft endoleak
|
5.0%
4/80 • Number of events 4 • 1 year
|
Additional Information
Alan Saunders, MS, RAC; Manager, Biostatistics
Cook Research Incorporated
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60