Trial Outcomes & Findings for European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (NCT NCT02477111)
NCT ID: NCT02477111
Last Updated: 2024-04-09
Results Overview
MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
Recruitment status
COMPLETED
Target enrollment
150 participants
Primary outcome timeframe
Within 30-days post-procedure
Results posted on
2024-04-09
Participant Flow
Participants were recruited based on physician referral at 25 academic medical centers between 2015 and the last participant was enrolled September 15, 2016
Of the 154 screened patients, 150 met inclusion criteria were enrolled in the study and 4 were screen fail.
Participant milestones
| Measure |
InCraft® - AAA Stent Graft System
Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
InCraft® - AAA Stent Graft System
Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
|
|---|---|
|
Overall Study
Death
|
28
|
|
Overall Study
Withdrawal by Subject
|
19
|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms
Baseline characteristics by cohort
| Measure |
InCraft® - AAA Stent Graft System
n=150 Participants
Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
|
|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=5 Participants
|
|
Angina
|
14 Participants
n=5 Participants
|
|
Arrhythmia
|
36 Participants
n=5 Participants
|
|
Coronary artery disease
|
44 Participants
n=5 Participants
|
|
Myocardial infarction
|
27 Participants
n=5 Participants
|
|
Percutaneous transluminal coronary angioplasty and/or stent
|
28 Participants
n=5 Participants
|
|
Coronary artery bypass grafting
|
19 Participants
n=5 Participants
|
|
Hypertension
|
120 Participants
n=5 Participants
|
|
Congestive heart failure
|
11 Participants
n=5 Participants
|
|
Family history of aneurysm
|
8 Participants
n=5 Participants
|
|
Transient Ischemic Attack
|
6 Participants
n=5 Participants
|
|
Stroke
|
9 Participants
n=5 Participants
|
|
Carotid endarterectomy/stent
|
2 Participants
n=5 Participants
|
|
Peripheral arterial disease
|
21 Participants
n=5 Participants
|
|
Diabetes
|
29 Participants
n=5 Participants
|
|
Hypercholesterolemia
|
68 Participants
n=5 Participants
|
|
Moderate renal insufficiency
|
18 Participants
n=5 Participants
|
|
Erectile disfunction
|
22 Participants
n=5 Participants
|
|
Chronic obstructive pulmonary disease (COPD)
|
35 Participants
n=5 Participants
|
|
Other chronic lung disease
|
8 Participants
n=5 Participants
|
|
Liver disease
|
3 Participants
n=5 Participants
|
|
Cancer
|
45 Participants
n=5 Participants
|
|
History of Smoking
|
122 Participants
n=5 Participants
|
|
Allergies
|
33 Participants
n=5 Participants
|
|
Other relevant medical history
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 30-days post-procedureMAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
Outcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=150 Participants
This is a single arm non-randomized study.
|
|---|---|
|
Number of Participants With Major Adverse Events (MAE) Through 30 Days
|
0 participants
Interval 0.0 to 2.4
|
SECONDARY outcome
Timeframe: Through 5 years post-procedureMAE rate through 5 year includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
Outcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=124 Participants
This is a single arm non-randomized study.
|
|---|---|
|
Number of Participants With Major Adverse Events Through 5 Years Post-Procedure
|
44 participants
Interval 33.604 to 55.304
|
SECONDARY outcome
Timeframe: At the conclusion of the index proceduresuccessful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location
Outcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=150 Participants
This is a single arm non-randomized study.
|
|---|---|
|
Number of Participants With Technical Success at Conclusion of Index Procedure
|
149 Participants
|
SECONDARY outcome
Timeframe: Within 1 year post-procedurePopulation: population analyzed only includes those that are eligible
defined as absence of type I or III endoleaks and absence of aneurysm enlargement (growth \>5mm compared to the 1-month size measurement) within 1-year post-procedure as assessed by the core lab
Outcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=115 Participants
This is a single arm non-randomized study.
|
|---|---|
|
Absence of Type I or III Endoleak
|
108 participants
Interval 101.085 to 112.125
|
SECONDARY outcome
Timeframe: Assessed at 1 yearPopulation: population analyzed only includes those that are eligible
Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
Outcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=122 Participants
This is a single arm non-randomized study.
|
|---|---|
|
InCraft® - AAA Stent Graft System
|
122 participants
Interval 118.4 to 122.0
|
SECONDARY outcome
Timeframe: Assessed within 30-days and 1-year post-procedurePopulation: Core lab reported outcome based on received and readable imaging
Outcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=141 Participants
This is a single arm non-randomized study.
|
|---|---|
|
Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure
|
141 Participants
|
SECONDARY outcome
Timeframe: Within 1-year post-procedureOutcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=138 Participants
This is a single arm non-randomized study.
|
|---|---|
|
Absence of Aneurysm Sac Rupture
|
138 Participants
|
SECONDARY outcome
Timeframe: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiographyDuration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Outcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=150 Participants
This is a single arm non-randomized study.
|
|---|---|
|
Duration of INCRAFT® Procedure (Minutes)
|
42.3 minutes
Interval 39.4 to 45.2
|
SECONDARY outcome
Timeframe: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiographyOutcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=150 Participants
This is a single arm non-randomized study.
|
|---|---|
|
Amount of Time Fluoroscopy is Used During the Procedure
|
17.3 minutes
Interval 15.9 to 18.8
|
SECONDARY outcome
Timeframe: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiographyOutcome measures
| Measure |
InCraft® - AAA Stent Graft System
n=150 Participants
This is a single arm non-randomized study.
|
|---|---|
|
Amount of Contrast Volume Used During the Procedure
|
99.4 ml
Interval 92.0 to 106.7
|
Adverse Events
INSIGHT
Serious events: 21 serious events
Other events: 22 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
INSIGHT
n=104 participants at risk
Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
|
|---|---|
|
Cardiac disorders
Cardiac disorders
|
4.8%
5/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.9%
3/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
General disorders
General disorders and administration site conditions
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Immune system disorders
Immune system disorders
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Infections and infestations
Infections and infestations
|
4.8%
5/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Nervous system disorders
Nervous system disorders
|
2.9%
3/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Vascular disorders
Vascular disorders
|
1.9%
2/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
Other adverse events
| Measure |
INSIGHT
n=104 participants at risk
Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Cardiac disorders
Cardiac arrhythmias
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
General disorders
General disorders and administration site conditions
|
4.8%
5/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Infections and infestations
Infections and infestations
|
2.9%
3/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Investigations
Investigations
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Nervous system disorders
Nervous system disorders
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Product Issues
Product issues
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.00%
0/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Vascular disorders
Vascular disorders
|
6.7%
7/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Eye disorders
Eye disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
3.8%
4/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
|
0.96%
1/104 • Adverse events are collected from index procedure until completion of study or early termination
All-cause mortality, Serious Adverse Events, other (Not including serious) Adverse Events
|
Additional Information
Jennifer Lee, Clinical Project Manager
Cordis, A Cardinal Health Company
Phone: 669-699-6851
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place