Trial Outcomes & Findings for PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study (NCT NCT02571907)
NCT ID: NCT02571907
Last Updated: 2025-07-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6 months
Results posted on
2025-07-16
Participant Flow
Participant milestones
| Measure |
Zenith® Branch Endovascular Graft-Iliac Bifurcation
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Atrium iCAST™: Implantation of Atrium iCAST
Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Zenith® Branch Endovascular Graft-Iliac Bifurcation
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Atrium iCAST™: Implantation of Atrium iCAST
Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study
Baseline characteristics by cohort
| Measure |
Zenith® Branch Endovascular Graft-Iliac Bifurcation
n=40 Participants
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Atrium iCAST™: Implantation of Atrium iCAST
Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft
|
|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: One patient died prior to the 6-month visit and thus did not contribute data to the primary outcome. This death was related to a pre-existing condition.
Outcome measures
| Measure |
Zenith® Branch Endovascular Graft-Iliac Bifurcation
n=39 Participants
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Atrium iCAST™: Implantation of Atrium iCAST
Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft
|
|---|---|
|
Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms.
|
39 Participants
|
SECONDARY outcome
Timeframe: 30 daysMorbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).
Outcome measures
| Measure |
Zenith® Branch Endovascular Graft-Iliac Bifurcation
n=40 Participants
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Atrium iCAST™: Implantation of Atrium iCAST
Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft
|
|---|---|
|
Freedom From Morbidity (i.e., Morbidity Index)
|
34 Participants
|
Adverse Events
Zenith® Branch Endovascular Graft-Iliac Bifurcation
Serious events: 26 serious events
Other events: 15 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Zenith® Branch Endovascular Graft-Iliac Bifurcation
n=40 participants at risk
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Atrium iCAST™: Implantation of Atrium iCAST
Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft
|
|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Endocrine disorders
Adrenal insufficiency
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Hiatus hernia
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Ileus
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
General disorders
Chest pain
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
General disorders
Stent-graft endoleak
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
General disorders
Vascular stent stenosis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
General disorders
Vascular stent thrombosis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Infections and infestations
Appendicitis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Infections and infestations
Diverticulitis
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Infections and infestations
Gastrointestinal infection
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Infections and infestations
Localised infection
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Infections and infestations
Pneumonia
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Infections and infestations
Sepsis
|
10.0%
4/40 • Number of events 4 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
7.5%
3/40 • Number of events 4 • 5 years
|
|
Infections and infestations
Vascular graft infection
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Central cord syndrome
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Concussion
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
3/40 • Number of events 4 • 5 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Investigations
Ammonia increased
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Investigations
Blood creatinine increased
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Investigations
Oxygen saturation decreased
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Investigations
Troponin I increased
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Nervous system disorders
Carotid artery stenosis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Nervous system disorders
Intraventricular haemorrhage
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Nervous system disorders
Transient ischaemic attack
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Depression
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Suicide attempt
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Neurogenic bladder
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal artery stenosis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.5%
3/40 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Hip arthroplasty
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Vascular disorders
Aneurysm
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Vascular disorders
Arterial thrombosis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Vascular disorders
Haematoma
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Vascular disorders
Intermittent claudication
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Vascular disorders
Peripheral artery aneurysm
|
10.0%
4/40 • Number of events 4 • 5 years
|
|
Vascular disorders
Peripheral ischaemia
|
2.5%
1/40 • Number of events 1 • 5 years
|
|
Vascular disorders
Thrombosis
|
2.5%
1/40 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Zenith® Branch Endovascular Graft-Iliac Bifurcation
n=40 participants at risk
Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Atrium iCAST™ and the Zenith® Flex AAA Endovascular Graft
Zenith® Branch Endovascular Graft-Iliac Bifurcation,: Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
Atrium iCAST™: Implantation of Atrium iCAST
Zenith® Flex AAA Endovascular Graft: Implantation of the Zenith Flex Endovascular Graft
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
7.5%
3/40 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
12.5%
5/40 • Number of events 5 • 5 years
|
|
Reproductive system and breast disorders
Testicular pain
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Vascular disorders
Aortic aneurysm
|
5.0%
2/40 • Number of events 2 • 5 years
|
|
Vascular disorders
Arterial thrombosis
|
5.0%
2/40 • Number of events 2 • 5 years
|
Additional Information
Alan Saunders, MS, Senior 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