Trial Outcomes & Findings for A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION) (NCT NCT01664078)

NCT ID: NCT01664078

Last Updated: 2024-07-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 190 participants
• Primary outcome timeframe: 30 days post-procedure
• Results posted on: 2024-07-03

Participant Flow

Participant milestones

Measure	InCraft® - AAA Stent Graft System Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®
Overall Study STARTED	190
Overall Study COMPLETED	121
Overall Study NOT COMPLETED	69

Reasons for withdrawal

Measure	InCraft® - AAA Stent Graft System Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®
Overall Study Death	9
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	2
Overall Study missed 5 year visit	1
Overall Study Other	53

Baseline Characteristics

Analysis was split between male and female measurements.

Baseline characteristics by cohort

Measure	InCraft® - AAA Stent Graft System n=190 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®
Age, Continuous Male	73.6 years STANDARD_DEVIATION 7.58 • n=171 Participants • Analysis was split between male and female measurements.
Age, Continuous Female	75.3 years STANDARD_DEVIATION 7.47 • n=19 Participants • Analysis was split between male and female measurements.
Sex: Female, Male Female	19 Participants n=190 Participants
Sex: Female, Male Male	171 Participants n=190 Participants
Region of Enrollment United States	134 participants n=190 Participants
Region of Enrollment Japan	56 participants n=190 Participants

PRIMARY outcome

Timeframe: 30 days post-procedure

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

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=183 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years procedure-related complications were tabulated as secondary safety endpoints
Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate	20 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 1 year post-procedure

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.

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=173 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years procedure-related complications were tabulated as secondary safety endpoints
Number of Participants With Successful Aneurysm Treatment	152 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through 1 month, 180-days, 360-days and annually to 5-years post-procedure

Adverse events that are a result of the procedure itself.

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=190 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days n=189 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days n=188 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years n=186 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years n=185 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years n=185 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years n=186 Participants procedure-related complications were tabulated as secondary safety endpoints
Procedure-related Complications	98 Participants	100 Participants	104 Participants	104 Participants	109 Participants	112 Participants	113 Participants

SECONDARY outcome

Timeframe: At 30-days, 180-days, 360-days and annually to 5-years post-procedure

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=190 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days n=187 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days n=183 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years n=176 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years n=172 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years n=168 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years n=165 Participants procedure-related complications were tabulated as secondary safety endpoints
Aneurysm-related Mortality	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: through 5 years

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.

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=189 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days n=183 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days n=176 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years n=162 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years n=149 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years n=132 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years n=118 Participants procedure-related complications were tabulated as secondary safety endpoints
Incidence of Secondary Interventions	1 Participants	5 Participants	8 Participants	7 Participants	12 Participants	8 Participants	4 Participants

SECONDARY outcome

Timeframe: At 180-days, 360-days and annually to 5-years post-procedure

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=187 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days n=183 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days n=176 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years n=172 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years n=168 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years n=165 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years procedure-related complications were tabulated as secondary safety endpoints
Major Adverse Events (MAEs) and Individual Components of the MAEs Myocardial infarction	3 Participants	6 Participants	7 Participants	9 Participants	12 Participants	13 Participants	—
Major Adverse Events (MAEs) and Individual Components of the MAEs Death	3 Participants	6 Participants	12 Participants	22 Participants	35 Participants	45 Participants	—
Major Adverse Events (MAEs) and Individual Components of the MAEs Stroke	3 Participants	4 Participants	9 Participants	13 Participants	15 Participants	17 Participants	—
Major Adverse Events (MAEs) and Individual Components of the MAEs New onset renal failure (requiring dialysis)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Major Adverse Events (MAEs) and Individual Components of the MAEs Respiratory failure (requiring mechanical ventilat	1 Participants	2 Participants	2 Participants	2 Participants	2 Participants	2 Participants	—
Major Adverse Events (MAEs) and Individual Components of the MAEs Paralysis / paraparesis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Major Adverse Events (MAEs) and Individual Components of the MAEs Bowel ischemia (requiring surgical intervention)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
Major Adverse Events (MAEs) and Individual Components of the MAEs Procedural blood loss (≥1,000 cc)	4 Participants	4 Participants	4 Participants	4 Participants	4 Participants	4 Participants	—

SECONDARY outcome

Timeframe: At 1 month, 6 months, 1 year and annually to 5-years post-procedure

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.

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=181 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days n=167 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days n=159 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years n=141 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years n=131 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years n=115 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years n=104 Participants procedure-related complications were tabulated as secondary safety endpoints
Device-related Events	0 Participants	7 Participants	16 Participants	24 Participants	40 Participants	42 Participants	48 Participants

SECONDARY outcome

Timeframe: At 30-days

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.

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=188 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years procedure-related complications were tabulated as secondary safety endpoints
Technical Success Confirmed by CT or Other Imaging Modality	188 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 17 days

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=190 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years procedure-related complications were tabulated as secondary safety endpoints
Length of Hospital Stay (Days) Post Index Procedure	2.7 days Standard Deviation 2.88	—	—	—	—	—	—

SECONDARY outcome

Timeframe: up to 48 hours

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=190 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years procedure-related complications were tabulated as secondary safety endpoints
Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure	8 hours Interval 0.0 to 18.59	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 day

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=190 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years procedure-related complications were tabulated as secondary safety endpoints
Length of the Index Procedure (Minutes)	102.7 minutes Interval 58.83 to 146.57	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 1 month, 6 months and 1 year post-procedure

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.

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=187 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days n=188 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days n=179 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years n=175 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years procedure-related complications were tabulated as secondary safety endpoints
Pain Post-Operatively	71.4 Units on a Scale Interval 45.18 to 97.62	70.2 Units on a Scale Interval 44.7 to 95.7	71.5 Units on a Scale Interval 43.9 to 99.1	73.1 Units on a Scale Interval 47.68 to 98.52	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, 1 month, 6 months and 1 year post-procedure

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.

Outcome measures

Measure	InCraft® - AAA Stent Graft System n=188 Participants Intervention: Endovascular AAA repair using the InCraft device Endovascular AAA repair with InCraft®	Site-reported Procedure-related AEs Through 180 Days n=188 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 360 Days n=179 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 2 Years n=175 Participants procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 3 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 4 Years procedure-related complications were tabulated as secondary safety endpoints	Site-reported Procedure-related AEs Through 5 Years procedure-related complications were tabulated as secondary safety endpoints
Physical Functioning Post-operatively	69.2 Units on a Scale Interval 42.96 to 95.44	66.5 Units on a Scale Interval 38.93 to 94.07	68.6 Units on a Scale Interval 41.43 to 95.77	68.2 Units on a Scale Interval 41.49 to 94.91	—	—	—

Adverse Events

InCraft

Serious events: 52 serious events

Other events: 93 other events

Deaths: 45 deaths

Serious adverse events

Measure	InCraft n=188 participants at risk Infrarenal Abdominal Aortic Aneurysm Stent Graft System
Cardiac disorders Cardiac disorders	8.0% 15/188 • Adverse events were 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 disorders	0.53% 1/188 • Adverse events were 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	2.7% 5/188 • Adverse events were 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	3.7% 7/188 • Adverse events were 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	1.1% 2/188 • Adverse events were 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 complications2	3.2% 6/188 • Adverse events were 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	0.53% 1/188 • Adverse events were 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)	3.2% 6/188 • Adverse events were 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	4.8% 9/188 • Adverse events were 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	0.53% 1/188 • Adverse events were 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	3.2% 6/188 • Adverse events were 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	4.8% 9/188 • Adverse events were collected from index procedure until completion of study or early termination. All-Cause Mortality, Serious Adverse Events, Other (Not Including Serious) Adverse Events.
Blood and lymphatic system disorders Blood and Lymphatic	1.1% 2/188 • Adverse events were 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 Metabolisms and Nutrition Disorders	1.6% 3/188 • Adverse events were 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	1.1% 2/188 • Adverse events were 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	InCraft n=188 participants at risk Infrarenal Abdominal Aortic Aneurysm Stent Graft System
Gastrointestinal disorders Gastrointestinal disorders	8.0% 15/188 • Adverse events were 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	8.0% 15/188 • Adverse events were 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	5.3% 10/188 • Adverse events were 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 complications1	8.0% 15/188 • Adverse events were 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	7.4% 14/188 • Adverse events were 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	5.9% 11/188 • Adverse events were 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	6.9% 13/188 • Adverse events were 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	8.5% 16/188 • Adverse events were 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 disorders4	10.6% 20/188 • Adverse events were 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

Cordis US Corp

Phone: +1-669-699-6851

Email: jennifer.lee02@cordis.com

Results disclosure agreements

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