Trial Outcomes & Findings for Zenith® Dissection Endovascular System (NCT NCT02094300)

NCT ID: NCT02094300

Last Updated: 2017-02-06

Results Overview

Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

30 days

Results posted on

2017-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Zenith® Dissection Endovascular Graft The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
Overall Study STARTED	26
Overall Study 30 Days	24
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Zenith® Dissection Endovascular Graft The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
Overall Study Death	7
Overall Study Lost to Follow-up	10
Overall Study Still be eligible for follow-up	3

Baseline Characteristics

Zenith® Dissection Endovascular System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zenith® Dissection Endovascular Graft n=26 Participants The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
Age, Continuous	61.3 years STANDARD_DEVIATION 15 • n=5 Participants
Gender Female	7 Participants n=5 Participants
Gender Male	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: There were 8 patients experienced 30-day major complications.

Outcome measures

Outcome measures
Measure	Zenith® Dissection Endovascular Graft n=26 Participants The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
Number of Patients With Major Complications Paralysis or paraparesis unresolved after 30 days	2 participants
Number of Patients With Major Complications Stroke	4 participants
Number of Patients With Major Complications Retrograde Type A dissection	2 participants
Number of Patients With Major Complications Renal failure requiring dialysis	3 participants
Number of Patients With Major Complications Prolonged ventilation requiring tracheotomy	3 participants

Adverse Events

Zenith® Dissection Endovascular Graft

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zenith® Dissection Endovascular Graft n=26 participants at risk The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
Vascular disorders Rupture of the aorta at the original entry tear	3.8% 1/26 • Number of events 1 • 30 days
Nervous system disorders Stroke, midbrain and cerebellar	3.8% 1/26 • Number of events 1 • 30 days

Other adverse events

Other adverse events
Measure	Zenith® Dissection Endovascular Graft n=26 participants at risk The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
Cardiac disorders Arrhythmia requiring intervention or new treatment	15.4% 4/26 • Number of events 4 • 30 days
Cardiac disorders Refractory hypertension	11.5% 3/26 • Number of events 3 • 30 days
Gastrointestinal disorders Paralytic ileus > 4 days	7.7% 2/26 • Number of events 2 • 30 days
Nervous system disorders Stroke	15.4% 4/26 • Number of events 4 • 30 days
Respiratory, thoracic and mediastinal disorders Pleural effusion requiring treatment	7.7% 2/26 • Number of events 2 • 30 days
Respiratory, thoracic and mediastinal disorders Pneumonia requiring antibiotics	7.7% 2/26 • Number of events 2 • 30 days
Respiratory, thoracic and mediastinal disorders Pulmonary event requiring tracheostomy or chest tube	19.2% 5/26 • Number of events 5 • 30 days
Respiratory, thoracic and mediastinal disorders Ventilation > 24 hours	19.2% 5/26 • Number of events 5 • 30 days
Renal and urinary disorders Renal failure requiring dialysis	11.5% 3/26 • Number of events 3 • 30 days
Renal and urinary disorders Serum creatinine rise > 30% above baseline resulting in a persistent value > 2.0 mg/dl	11.5% 3/26 • Number of events 3 • 30 days
Vascular disorders Post-procedure transfusion	26.9% 7/26 • Number of events 9 • 30 days
Vascular disorders Vascular injury	7.7% 2/26 • Number of events 3 • 30 days

Additional Information

Scott Snyder, PhD, Director of Clinical Science and 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