Trial Outcomes & Findings for Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study (NCT NCT01652235)

Last Updated: 2024-09-19

Results Overview

Successful access of the aneurysm site and deployment of the Zenith® Fenestrated AAA Endovascular Graft or the Zenith® p-Branch™ in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

Immediately post graft deployment

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Endovascular Experimental: Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Overall Study STARTED	28
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Endovascular Experimental: Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Overall Study Death	9
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endovascular n=28 Participants Experimental: Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants
Age, Categorical >=65 years	22 Participants n=99 Participants
Age, Continuous	73.2 Years n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	23 Participants n=99 Participants
Race/Ethnicity, Customized White	24 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=99 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=99 Participants
Race/Ethnicity, Customized Other	1 Participants n=99 Participants
Region of Enrollment United States	28 participants n=99 Participants

PRIMARY outcome

Timeframe: Immediately post graft deployment

Outcome measures

Outcome measures
Measure	Endovascular n=28 Participants Experimental: Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Technical Success:	28 participants

PRIMARY outcome

Timeframe: Within 30 days post graft deployment

Technical Success, with all of the following at post-procedure (within 30 days): * No type I or type III endoleaks; * No procedure related serious adverse events or major complications; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.

Outcome measures

Outcome measures
Measure	Endovascular n=28 Participants Experimental: Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Procedural Success	25 Participants

PRIMARY outcome

Timeframe: 12 months

Procedural Success, with all of the following at 12 months: * No type I or type III endoleaks; * No serious adverse events or major complications; * No aneurysm enlargement greater than 0.5 cm; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.

Outcome measures

Outcome measures
Measure	Endovascular n=28 Participants Experimental: Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Treatment Success	23 Participants

Adverse Events

Endovascular

Serious events: 4 serious events

Other events: 20 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Endovascular n=28 participants at risk Experimental: Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Gastrointestinal disorders Intestinal obstruction	3.6% 1/28 • Number of events 1 • 5 years
Infections and infestations Pneumonia	3.6% 1/28 • Number of events 1 • 5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	3.6% 1/28 • Number of events 1 • 5 years
Renal and urinary disorders Renal failure	3.6% 1/28 • Number of events 1 • 5 years

Other adverse events

Other adverse events
Measure	Endovascular n=28 participants at risk Experimental: Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Blood and lymphatic system disorders Anaemia	7.1% 2/28 • Number of events 3 • 5 years
Cardiac disorders Cardiac failure congestive	10.7% 3/28 • Number of events 3 • 5 years
Cardiac disorders Myocardial infarction	7.1% 2/28 • Number of events 2 • 5 years
General disorders Oedema peripheral	7.1% 2/28 • Number of events 2 • 5 years
Infections and infestations Pneumonia	7.1% 2/28 • Number of events 2 • 5 years
Infections and infestations Urinary tract infection	10.7% 3/28 • Number of events 4 • 5 years
Investigations Blood creatinine increased	25.0% 7/28 • Number of events 8 • 5 years
Metabolism and nutrition disorders Hypervolaemia	7.1% 2/28 • Number of events 2 • 5 years
Musculoskeletal and connective tissue disorders Back pain	10.7% 3/28 • Number of events 4 • 5 years
Renal and urinary disorders Renal artery occlusion	10.7% 3/28 • Number of events 3 • 5 years
Renal and urinary disorders Renal infarct	10.7% 3/28 • Number of events 3 • 5 years
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	7.1% 2/28 • Number of events 2 • 5 years
Surgical and medical procedures Mechanical ventilation	7.1% 2/28 • Number of events 2 • 5 years
Surgical and medical procedures Oxygen therapy	7.1% 2/28 • Number of events 2 • 5 years
Surgical and medical procedures Transfusion	28.6% 8/28 • Number of events 9 • 5 years
Vascular disorders Aneurysm	7.1% 2/28 • Number of events 2 • 5 years

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: LTE60