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Trial Outcomes & Findings for PRESERVE-Zenith® Iliac Branch System Clinical Study (NCT NCT01208415)

NCT ID: NCT01208415

Last Updated: 2018-04-04

Results Overview

Patency-related intervention is defined as: Secondary intervention to treat a \> 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

6 Months

Results posted on

2018-04-04

Participant Flow

Participant milestones

Participant milestones
Measure
Zenith® Iliac Branch System
Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
Overall Study
STARTED
40
Overall Study
6 Months
37
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
40

Reasons for withdrawal

Reasons for withdrawal
Measure
Zenith® Iliac Branch System
Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
Overall Study
Death
1
Overall Study
Lost to Follow-up
2
Overall Study
Withdrawal by Subject
3
Overall Study
Device not placed
1
Overall Study
Still be eligible for follow-up
33

Baseline Characteristics

PRESERVE-Zenith® Iliac Branch System Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Zenith® Iliac Branch System
n=40 Participants
Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
Age, Continuous
69 years
STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
39 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Of the 37 patients available for analysis at 6 months, data was available for 34 patients.

Patency-related intervention is defined as: Secondary intervention to treat a \> 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.

Outcome measures

Outcome measures
Measure
Device Implant
n=34 Participants
Endovascular repair for aortoiliac or iliac aneurysms.: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.
Patients That Are Free From Patency-related Intervention
33 participants

Adverse Events

Zenith® Iliac Branch System

Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Zenith® Iliac Branch System
n=40 participants at risk
Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
Nervous system disorders
Spinal cord infarct
2.5%
1/40 • Number of events 1 • 180 days
Gastrointestinal disorders
Gastroenteritis
2.5%
1/40 • Number of events 1 • 180 days
Gastrointestinal disorders
Gastrointestinal bleeding
2.5%
1/40 • Number of events 1 • 180 days
Renal and urinary disorders
Urinary retention
2.5%
1/40 • Number of events 1 • 180 days
Vascular disorders
Thrombosis
2.5%
1/40 • Number of events 1 • 180 days
General disorders
Confusion
2.5%
1/40 • Number of events 1 • 180 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkins lymphoma
2.5%
1/40 • Number of events 1 • 180 days
Musculoskeletal and connective tissue disorders
Bursitis with overlying cellulitis
2.5%
1/40 • Number of events 1 • 180 days
Cardiac disorders
Hypotension
2.5%
1/40 • Number of events 1 • 180 days

Other adverse events

Other adverse events
Measure
Zenith® Iliac Branch System
n=40 participants at risk
Zenith® Branch Endovascular Graft-Iliac Bifurcation System is made up of two devices: the Zenith® Branch Endovascular Graft-Iliac Bifurcation and the ConnectSX™.
Surgical and medical procedures
Groin seroma
7.5%
3/40 • Number of events 3 • 180 days
Surgical and medical procedures
Groin hematoma
5.0%
2/40 • Number of events 2 • 180 days
Renal and urinary disorders
Urinary retention
7.5%
3/40 • Number of events 3 • 180 days

Additional Information

Scott Snyder, PhD, Director of Clinical Affairs

Cook Research Incorporated

Phone: 765-463-7537

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60