Abdominal Aortic Aneurysms
Conditions
Keywords
Endovascular repair
Brief summary
INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.
Detailed description
INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years postprocedure. Up to 25 sites in Europe may participate. Subjects will be enrolled and followed at 1 month and 6 month post-procedure and annually up to 5 years.
Interventions
DEVICEEndovascular abdominal aortic aneurysm repair
Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.
Sponsors
Cordis US Corp.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female age 18 years or older 2. Femoral access vessels should be adequate to fit the selected delivery system 3. Proximal neck length ≥ 10mm 4. Aortic neck diameters ≥ 17mm and ≤ 31mm 5. Aortic neck suitable for suprarenal fixation 6. Infrarenal and suprarenal neck angulation ≤ 60° 7. Iliac fixation length ≥ 15mm 8. Iliac diameters ≥ 7mm and ≤ 22mm 9. Minimum overall AAA treatment length (proximal landing location to distal landing location) ≥ 128mm 10. Morphology suitable for aneurysm repair 11. Provide written informed consent and as applicable written confidentiality authorization prior to initiation of study procedures 12. Subject is willing to comply with the specified follow-up evaluation schedule
Exclusion criteria
1. Subject has one of the following: 1. Aneurysm sac rupture or leaking abdominal aortic aneurysm 2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm 2. Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate (PET), or polytetrafluoroethylene (PTFE) 3. Known contraindication to undergoing angiography or anticoagulation 4. Existing AAA surgical graft and/or a AAA stent-graft system 5. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Events (MAE) Through 30 Days | Within 30-days post-procedure | MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Technical Success at Conclusion of Index Procedure | At the conclusion of the index procedure | successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location |
| Absence of Type I or III Endoleak | Within 1 year post-procedure | 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 |
| InCraft® - AAA Stent Graft System | Assessed at 1 year | Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System |
| Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure | Assessed within 30-days and 1-year post-procedure | — |
| Number of Participants With Major Adverse Events Through 5 Years Post-Procedure | Through 5 years post-procedure | MAE rate through 5 year includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis) |
| Duration of INCRAFT® Procedure (Minutes) | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography |
| Amount of Time Fluoroscopy is Used During the Procedure | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography | — |
| Amount of Contrast Volume Used During the Procedure | Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography | — |
| Absence of Aneurysm Sac Rupture | Within 1-year post-procedure | — |
Countries
France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
Participants were recruited based on physician referral at 25 academic medical centers between 2015 and the last participant was enrolled September 15, 2016
Pre-assignment details
Of the 154 screened patients, 150 met inclusion criteria were enrolled in the study and 4 were screen fail.
Participants by arm
| Arm | Count |
|---|---|
| InCraft® - AAA Stent Graft System Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 28 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 19 |
Baseline characteristics
| Characteristic | InCraft® - AAA Stent Graft System |
|---|---|
| Age, Continuous | 73.6 years STANDARD_DEVIATION 8 |
| Allergies | 33 Participants |
| Angina | 14 Participants |
| Arrhythmia | 36 Participants |
| Cancer | 45 Participants |
| Carotid endarterectomy/stent | 2 Participants |
| Chronic obstructive pulmonary disease (COPD) | 35 Participants |
| Congestive heart failure | 11 Participants |
| Coronary artery bypass grafting | 19 Participants |
| Coronary artery disease | 44 Participants |
| Diabetes | 29 Participants |
| Erectile disfunction | 22 Participants |
| Family history of aneurysm | 8 Participants |
| History of Smoking | 122 Participants |
| Hypercholesterolemia | 68 Participants |
| Hypertension | 120 Participants |
| Liver disease | 3 Participants |
| Moderate renal insufficiency | 18 Participants |
| Myocardial infarction | 27 Participants |
| Other chronic lung disease | 8 Participants |
| Other relevant medical history | 37 Participants |
| Percutaneous transluminal coronary angioplasty and/or stent | 28 Participants |
| Peripheral arterial disease | 21 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 134 Participants |
| Stroke | 9 Participants |
| Transient Ischemic Attack | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 28 / 124 |
| other Total, other adverse events | 22 / 104 |
| serious Total, serious adverse events | 21 / 104 |
Outcome results
Primary
Number of Participants With Major Adverse Events (MAE) Through 30 Days
MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
Time frame: Within 30-days post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Number of Participants With Major Adverse Events (MAE) Through 30 Days | 0 participants |
Secondary
Absence of Aneurysm Sac Rupture
Time frame: Within 1-year post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Absence of Aneurysm Sac Rupture | 138 Participants |
Secondary
Absence of Type I or III Endoleak
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
Time frame: Within 1 year post-procedure
Population: population analyzed only includes those that are eligible
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Absence of Type I or III Endoleak | 108 participants |
Secondary
Amount of Contrast Volume Used During the Procedure
Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
| Arm | Measure | Value (MEAN) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Amount of Contrast Volume Used During the Procedure | 99.4 ml |
Secondary
Amount of Time Fluoroscopy is Used During the Procedure
Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
| Arm | Measure | Value (MEAN) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Amount of Time Fluoroscopy is Used During the Procedure | 17.3 minutes |
Secondary
Duration of INCRAFT® Procedure (Minutes)
Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
Time frame: Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
| Arm | Measure | Value (MEAN) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Duration of INCRAFT® Procedure (Minutes) | 42.3 minutes |
Secondary
InCraft® - AAA Stent Graft System
Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
Time frame: Assessed at 1 year
Population: population analyzed only includes those that are eligible
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InCraft® - AAA Stent Graft System | InCraft® - AAA Stent Graft System | 122 participants |
Secondary
Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure
Time frame: Assessed within 30-days and 1-year post-procedure
Population: Core lab reported outcome based on received and readable imaging
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Number of Participants With Absence of Stent Graft Fracture Within 30-days and 1-year Post-procedure | 141 Participants |
Secondary
Number of Participants With Major Adverse Events Through 5 Years Post-Procedure
MAE rate through 5 year includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
Time frame: Through 5 years post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Number of Participants With Major Adverse Events Through 5 Years Post-Procedure | 44 participants |
Secondary
Number of Participants With Technical Success at Conclusion of Index Procedure
successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location
Time frame: At the conclusion of the index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| InCraft® - AAA Stent Graft System | Number of Participants With Technical Success at Conclusion of Index Procedure | 149 Participants |