An interventional study of Endovascular AAA repair with InCraft® in Abdominal Aortic Aneurysm, sponsored by Cordis US Corp.. Completed at 2 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Cordis US Corp. · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair.
In the US, abdominal aortic aneurysms (AAA) are found in 4-8% of older men and 0.5-1.5% of older women, resulting in 30,000-40,000 elective procedures and 1,400 peri-operative deaths. The most significant complication of AAA is an aneurysm sac rupture from which more than 15,000 patients die annually and is the 15th leading cause of death in elderly between 60 to 85 years of age . In Japan, it is estimated that approximately 14,000 endovascular aneurysm repair (EVAR) and open surgical repair cases were performed in the year 2010 .
Abdominal aortic aneurysms can be treated three ways: (1) Medical management; (2) Open surgical repair; and (3) Endovascular aneurysm repair (EVAR). EVAR has emerged as an alternative treatment of AAA for most patients. It is less invasive than open repair and carries lower rates of early mortality and morbidity . It has also extended treatment options to patients who cannot undergo conventional surgical procedures due to a high operative risk. As EVAR technology evolves, it allows treatment of AAA with increasing complexity of the aortic neck and access vessels.
The InCraft® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs with complex aortic anatomies. This stent-graft system utilizes nitinol stent and polyester graft technology in an ultra-low profile delivery system, which assists the physician in deploying the device in a controlled, consistent, and precise manner within the aortic neck and iliac arteries. By isolating the aneurysmal sac, the system provides an alternative blood flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and the potential for aneurysm sac rupture.
481 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 190 is above the median of 68 across 236 interventional studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Cordis US Corp. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject must meet ALL of the following inclusion criteria to be enrolled in the study:
Subject has at least one of the following:
Exclusion Criteria:
Subjects will be excluded if ANY of the following exclusion criteria apply:
Subject has one of the following:
Intervention: Endovascular AAA repair using the InCraft device
Device: Endovascular AAA repair with InCraft®
Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate
defined as a composite of: * Death * Stroke * Myocardial Infarction * New Onset Renal Failure (requiring dialysis) * Respiratory Failure (requires mechanical ventilation) * Paralysis/paraparesis * Bowel ischemia (requiring surgical intervention) * Procedural blood loss ≥1,000 cc
Time frame: 30 days post-procedure
Number of Participants With Successful Aneurysm Treatment
Successful aneurysm treatment which is a composite endpoint of the following: * Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality; * Absence of post-operative aneurysm enlargement (growth \> 5 mm) or stent graft migration (\> 10mm) compared to the one month size measurement at anytime up to 1-year; * Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year.
Time frame: Up to 1 year post-procedure
Procedure-related Complications
Adverse events that are a result of the procedure itself.
Time frame: Through 1 month, 180-days, 360-days and annually to 5-years post-procedure
Aneurysm-related Mortality
Time frame: At 30-days, 180-days, 360-days and annually to 5-years post-procedure
Incidence of Secondary Interventions
The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth \> 5 mm), stent graft migration (\> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
Time frame: through 5 years
Major Adverse Events (MAEs) and Individual Components of the MAEs
Time frame: At 180-days, 360-days and annually to 5-years post-procedure
Device-related Events
Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft \>10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter \> 5mm compared to the 1-month measurement.
Time frame: At 1 month, 6 months, 1 year and annually to 5-years post-procedure
Technical Success Confirmed by CT or Other Imaging Modality
The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality.
Time frame: At 30-days
Length of Hospital Stay (Days) Post Index Procedure
Time frame: up to 17 days
Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure
Time frame: up to 48 hours
Length of the Index Procedure (Minutes)
Time frame: 1 day
Pain Post-Operatively
Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time frame: Baseline, 1 month, 6 months and 1 year post-procedure
Physical Functioning Post-operatively
Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time frame: Screening, 1 month, 6 months and 1 year post-procedure
| Milestone | InCraft® - AAA Stent Graft System |
|---|---|
| Started | 190 |
| Completed | 121 |
| Not completed | 69 |
| Withdrew: Death | 9 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Missed 5 year visit | 1 |
| Withdrew: Other | 53 |
defined as a composite of: * Death * Stroke * Myocardial Infarction * New Onset Renal Failure (requiring dialysis) * Respiratory Failure (requires mechanical ventilation) * Paralysis/paraparesis * Bowel ischemia (requiring surgical intervention) * Procedural blood loss ≥1,000 cc
| Participants | InCraft® - AAA Stent Graft System |
|---|---|
| Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate | 20 |
Successful aneurysm treatment which is a composite endpoint of the following: * Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality; * Absence of post-operative aneurysm enlargement (growth \> 5 mm) or stent graft migration (\> 10mm) compared to the one month size measurement at anytime up to 1-year; * Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year.
| Participants | InCraft® - AAA Stent Graft System |
|---|---|
| Number of Participants With Successful Aneurysm Treatment | 152 |
Adverse events that are a result of the procedure itself.
| Participants | Site-reported Procedure-related AEs Through 1 Month | Site-reported Procedure-related AEs Through 180 Days | Site-reported Procedure-related AEs Through 360 Days | Site-reported Procedure-related AEs Through 2 Years | Site-reported Procedure-related AEs Through 3 Years | Site-reported Procedure-related AEs Through 4 Years | Site-reported Procedure-related AEs Through 5 Years |
|---|---|---|---|---|---|---|---|
| Procedure-related Complications | 98 | 100 | 104 | 104 | 109 | 112 | 113 |
| Participants | Aneurysm-related Morality Through 1 Month | Aneurysm-related Morality Through 180 Days | Aneurysm-related Morality Through 360 Days | Aneurysm-related Morality Through 2 Years | Aneurysm-related Morality Through 3 Years | Aneurysm-related Morality Through 4 Years | Aneurysm-related Morality Through 5 Years |
|---|---|---|---|---|---|---|---|
| Aneurysm-related Mortality | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth \> 5 mm), stent graft migration (\> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
| Participants | Secondary Intervention Through 1 Month | Secondary Intervention Through 180 Days | Secondary Intervention Through 360 Days | Secondary Intervention Through 2 Years | Secondary Intervention Through 3 Years | Secondary Intervention Through 4 Years | Secondary Intervention Through 5 Years |
|---|---|---|---|---|---|---|---|
| Incidence of Secondary Interventions | 1 | 5 | 8 | 7 | 12 | 8 | 4 |
| Participants | MAEs Through 180 Days | MAEs Through 360 Days | MAEs Through 2 Years | MAEs Through 3 Years | MAEs Through 4 Years | MAEs Through 5 Years |
|---|---|---|---|---|---|---|
| Death | 3 | 6 | 12 | 22 | 35 | 45 |
| Stroke | 3 | 4 | 9 | 13 | 15 | 17 |
| Myocardial infarction | 3 | 6 | 7 | 9 | 12 | 13 |
| New onset renal failure (requiring dialysis) | 0 | 0 | 0 | 0 | 0 | 0 |
| Respiratory failure (requiring mechanical ventilat | 1 | 2 | 2 | 2 | 2 | 2 |
| Paralysis / paraparesis | 0 | 0 | 0 | 0 | 0 | 0 |
| Bowel ischemia (requiring surgical intervention) | 0 | 0 | 0 | 0 | 0 | 1 |
| Procedural blood loss (≥1,000 cc) | 4 | 4 | 4 | 4 | 4 | 4 |
Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft \>10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter \> 5mm compared to the 1-month measurement.
| Participants | Device-related Events Through 1 Month | Device-related Events Through 180 Days | Device-related Events Through 360 Days | Device-related Events Through 2 Years | Device-related Events Through 3 Years | Device-related Events Through 4 Years | Device-related Events Through 5 Years |
|---|---|---|---|---|---|---|---|
| Device-related Events | 0 | 7 | 16 | 24 | 40 | 42 | 48 |
The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality.
| Participants | Technical Success |
|---|---|
| Technical Success Confirmed by CT or Other Imaging Modality | 188 |
| days | Length of Hospital Stay (Days) Post Index Procedure |
|---|---|
| Length of Hospital Stay (Days) Post Index Procedure | 2.7 ± 2.88 |
| hours | Length of Intensive Care Unit (ICU) Stay (Hours) Post Index pr |
|---|---|
| Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure | 8 (0 to 18.59) |
| minutes | Length of the Index Procedure (Minutes) |
|---|---|
| Length of the Index Procedure (Minutes) | 102.7 (58.83 to 146.57) |
Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
| Units on a Scale | Pain Post-Operatively at Baseline | Pain Post-Operatively at 1-Month | Pain Post-Operatively at 6-Months | Pain Post-Operatively at 1-Year |
|---|---|---|---|---|
| Pain Post-Operatively | 71.4 (45.18 to 97.62) | 70.2 (44.7 to 95.7) | 71.5 (43.9 to 99.1) | 73.1 (47.68 to 98.52) |
Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
| Units on a Scale | Physical Functioning Post-operatively at Baseline | Physical Functioning Post-operatively at 1 Month | Physical Functioning Post-operatively at 6 Month | Physical Functioning Post-operatively at 1 Year |
|---|---|---|---|---|
| Physical Functioning Post-operatively | 69.2 (42.96 to 95.44) | 66.5 (38.93 to 94.07) | 68.6 (41.43 to 95.77) | 68.2 (41.49 to 94.91) |
Collected over Adverse events were collected from index procedure until completion of study or early termination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| InCraft | 45/188 (23.9%) | 52/188 (27.7%) | 93/188 (49.5%) |
| Event | InCraft |
|---|---|
| Cardiac disordersCardiac disorders | 15/188 |
| Nervous system disordersNervous system disorders | 9/188 |
| Vascular disordersVascular disorders | 9/188 |
| General disorders and administration site conditionsGeneral disorders | 7/188 |
| Injury, poisoning and procedural complications2Injury, poisoning and procedural complications | 6/188 |
| Neoplasms benign, malignant and unspecified (including cysts and polyps)Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 6/188 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 6/188 |
| Gastrointestinal disordersGastrointestinal disorders | 5/188 |
| Metabolisms and Nutrition DisordersMetabolism and nutrition disorders | 3/188 |
| Infections and infestationsInfections and infestations | 2/188 |
| Event | InCraft |
|---|---|
| Vascular disorders4Vascular disorders | 20/188 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 16/188 |
| Gastrointestinal disordersGastrointestinal disorders | 15/188 |
| General disorders and administration site conditionsGeneral disorders | 15/188 |
| Injury, poisoning and procedural complications1Injury, poisoning and procedural complications | 15/188 |
| Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 14/188 |
| Renal and urinary disordersRenal and urinary disorders | 13/188 |
| Nervous system disordersNervous system disorders | 11/188 |
| Infections and infestationsInfections and infestations | 10/188 |
| Age, Continuous(years) | InCraft® - AAA Stent Graft System |
|---|---|
| Male | 73.6 ± 7.58 |
| Female | 75.3 ± 7.47 |
| Sex: Female, Male(Participants) | InCraft® - AAA Stent Graft System |
|---|---|
| Female | 19 |
| Male | 171 |
| Region of Enrollment(participants) | InCraft® - AAA Stent Graft System |
|---|---|
| United States | 134 |
| Japan | 56 |
Plan to share: No
Ran from Jul 2012 to primary completion in Oct 2014, 27 months.
Results were first posted in Aug 2020, 5 years 10 months after primary completion. A results delay was requested in Jun 2017.
Of 42 industry-sponsored interventional studies with no phase under Aortic Aneurysm, Abdominal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 73. This study's 27 months is below that.
Counting every sponsor, half of 95 studies reached it within 47 months; a quarter within 23 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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