Trial Outcomes & Findings for Atrium iCAST Iliac Stent Pivotal Study (NCT NCT00593385)

NCT ID: NCT00593385

Last Updated: 2018-05-17

Results Overview

The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 165 participants
• Primary outcome timeframe: Within 9 Months post-procedure
• Results posted on: 2018-05-17

Participant Flow

Participant milestones

Measure	Device: ICAST Covered Stent Implantation of ≥ 1 ICAST stent
Overall Study STARTED	165
Overall Study Intention to Treat (ITT) Population	152
Overall Study COMPLETED	125
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Measure	Device: ICAST Covered Stent Implantation of ≥ 1 ICAST stent
Overall Study Death	14
Overall Study Lost to Follow-up	17
Overall Study Withdrawal by Subject	9

Baseline Characteristics

One subject was missing data.

Baseline characteristics by cohort

Measure	Device: ICAST Covered Stent n=152 Participants Implantation of ≥ 1 ICAST stent
Age, Continuous	65.23 years STANDARD_DEVIATION 9.96 • n=152 Participants
Sex: Female, Male Female	58 Participants n=152 Participants
Sex: Female, Male Male	94 Participants n=152 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=152 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	149 Participants n=152 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=152 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=152 Participants
Race (NIH/OMB) Asian	0 Participants n=152 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=152 Participants
Race (NIH/OMB) Black or African American	8 Participants n=152 Participants
Race (NIH/OMB) White	142 Participants n=152 Participants
Race (NIH/OMB) More than one race	2 Participants n=152 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=152 Participants
Region of Enrollment United States	132 participants n=152 Participants
Region of Enrollment Germany	20 participants n=152 Participants
Cigarette Smoking Status Current smoker	76 Participants n=151 Participants • One subject was missing data.
Cigarette Smoking Status Former smoker	62 Participants n=151 Participants • One subject was missing data.
Cigarette Smoking Status Non-smoker	13 Participants n=151 Participants • One subject was missing data.
Cigarette Smoking Status Unknown	0 Participants n=151 Participants • One subject was missing data.
Previous Peripheral Artery Revascularization/Surgery	25 Participants n=150 Participants • Two subjects were missing data.
Coronary Artery Disease	77 Participants n=151 Participants • One subject was missing data.
Previous Myocardial Infarction (MI)	35 Participants n=151 Participants • One subject was missing data.
Previous percutaneous coronary revascularization	39 Participants n=151 Participants • One subject was missing data.
Coronary Artery Bypass Graft Surgery	34 Participants n=151 Participants • One subject was missing data.
Cerebrovascular Accident	11 Participants n=152 Participants
Previous Amputation	2 Participants n=152 Participants
Transient Ischemic Attack	7 Participants n=151 Participants • One subject was missing data.
Diabetes Mellitus	56 Participants n=152 Participants
Hypertension	129 Participants n=152 Participants
Hypercholesterolemia	130 Participants n=152 Participants
Renal Insufficiency	19 Participants n=152 Participants

PRIMARY outcome

Timeframe: Within 9 Months post-procedure

Population: ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.

The primary endpoint is a composite endpoint defined as the occurrence of death within 30 days, target site revascularization within 9 months or restenosis (by ultrasound determination) at 9 months.

Outcome measures

Measure	iCAST Covered Stent n=152 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis	8.1 Percentage of subjects

SECONDARY outcome

Timeframe: Post-procedure

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE.

Outcome measures

Measure	iCAST Covered Stent n=151 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Acute Procedural Success	140 Participants

SECONDARY outcome

Timeframe: Post-procedure

Population: ITT population: Subjects who signed the written informed consent, enrolled in the study and met the study entry criteria.

Successful delivery and deployment of the study stent and intact retrieval of the delivery system.

Outcome measures

Measure	iCAST Covered Stent n=152 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Device Success	150 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Composite rate of MAVE or any death, or stroke.

Outcome measures

Measure	iCAST Covered Stent n=151 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Major Adverse Event (MAE)	8 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.

Outcome measures

Measure	iCAST Covered Stent n=151 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Major Adverse Vascular Event (MAVE)	7 Participants

SECONDARY outcome

Timeframe: 180 Days

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.

Outcome measures

Measure	iCAST Covered Stent n=144 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Major Adverse Vascular Event (MAVE)	10 Participants

SECONDARY outcome

Timeframe: 270 Days

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.

Outcome measures

Measure	iCAST Covered Stent n=140 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Major Adverse Vascular Event (MAVE)	10 Participants

SECONDARY outcome

Timeframe: 360 Days

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, arterial rupture, acute limb ischemia, target limb amputation, or procedure related bleeding event requiring transfusion.

Outcome measures

Measure	iCAST Covered Stent n=139 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Major Adverse Vascular Event (MAVE)	10 Participants

SECONDARY outcome

Timeframe: 1 Month

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Improvement of the Rutherford-Becker clinical criteria by ≥ 1 category. (Classification system for evaluating clinical improvement as defined by Rutherford R, Becker G. Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. Journal of Vascular Interventional Radiology 1991;2:169-174.)

Outcome measures

Measure	iCAST Covered Stent n=150 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Early Clinical Success	133 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.

Outcome measures

Measure	iCAST Covered Stent n=126 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Late Clinical Success	80 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.

Outcome measures

Measure	iCAST Covered Stent n=128 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Late Clinical Success	98 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.

Outcome measures

Measure	iCAST Covered Stent n=128 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Late Clinical Success	86 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.

Outcome measures

Measure	iCAST Covered Stent n=113 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Late Clinical Success	80 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm.

Outcome measures

Measure	iCAST Covered Stent n=105 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Late Clinical Success	76 Participants

SECONDARY outcome

Timeframe: 1 Month

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow without revascularization, bypass or target limb amputation.

Outcome measures

Measure	iCAST Covered Stent n=151 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary Patency	151 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow without revascularization, bypass or target limb amputation.

Outcome measures

Measure	iCAST Covered Stent n=144 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary Patency	143 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow without revascularization, bypass or target limb amputation.

Outcome measures

Measure	iCAST Covered Stent n=139 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary Patency	134 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow without revascularization, bypass or target limb amputation.

Outcome measures

Measure	iCAST Covered Stent n=138 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary Patency	129 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow without revascularization, bypass or target limb amputation.

Outcome measures

Measure	iCAST Covered Stent n=129 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary Patency	113 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow without revascularization, bypass or target limb amputation.

Outcome measures

Measure	iCAST Covered Stent n=118 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary Patency	100 Participants

SECONDARY outcome

Timeframe: 1 Month

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow assisted when the target vessel has restenosed at any time post-procedure.

Outcome measures

Measure	iCAST Covered Stent n=151 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary-Assisted Patency	151 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow assisted when the target vessel has restenosed at any time post-procedure.

Outcome measures

Measure	iCAST Covered Stent n=144 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary-Assisted Patency	144 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow assisted when the target vessel has restenosed at any time post-procedure.

Outcome measures

Measure	iCAST Covered Stent n=139 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary-Assisted Patency	139 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow assisted when the target vessel has restenosed at any time post-procedure.

Outcome measures

Measure	iCAST Covered Stent n=138 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary-Assisted Patency	138 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow assisted when the target vessel has restenosed at any time post-procedure.

Outcome measures

Measure	iCAST Covered Stent n=129 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary-Assisted Patency	128 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Continuous flow assisted when the target vessel has restenosed at any time post-procedure.

Outcome measures

Measure	iCAST Covered Stent n=115 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Primary-Assisted Patency	114 Participants

SECONDARY outcome

Timeframe: 1 Month

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.

Outcome measures

Measure	iCAST Covered Stent n=151 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Secondary Patency	151 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.

Outcome measures

Measure	iCAST Covered Stent n=144 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Secondary Patency	144 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.

Outcome measures

Measure	iCAST Covered Stent n=139 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Secondary Patency	139 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.

Outcome measures

Measure	iCAST Covered Stent n=138 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Secondary Patency	138 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.

Outcome measures

Measure	iCAST Covered Stent n=129 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Secondary Patency	129 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Subset of ITT population with available data for analysis (ITT population included subjects who signed the written informed consent, enrolled in the study and met the study entry criteria).

Re-establishment of flow to distal arteries after occlusion has occurred at the target vessel.

Outcome measures

Measure	iCAST Covered Stent n=115 Participants Device: iCAST covered stent Implantation of ≥1 iCAST stents
Secondary Patency	115 Participants

Adverse Events

Device: ICAST Covered Stent

Serious events: 86 serious events

Other events: 22 other events

Deaths: 14 deaths

Serious adverse events

Measure	Device: ICAST Covered Stent n=165 participants at risk Implantation of ≥ 1 ICAST stent
Blood and lymphatic system disorders Anaemia	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Acute coronary syndrome	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Acute myocardial infarction	3.6% 6/165 • Number of events 8 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Angina pectoris	1.8% 3/165 • Number of events 5 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Angina unstable	1.8% 3/165 • Number of events 4 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Atrial fibrillation	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Atrial flutter	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Atrioventricular block	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Cardiac arrest	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Cardiac failure	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Cardiac failure congestive	4.2% 7/165 • Number of events 9 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Cardio-respiratory arrest	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Coronary artery disease	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Coronary artery occlusion	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Myocardial infarction	3.6% 6/165 • Number of events 6 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Stress cardiomyopathy	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Cardiac disorders Ventricular tachycardia	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Ear and labyrinth disorders Vertigo	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Abdominal pain	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Colitis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Gastritis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.8% 3/165 • Number of events 4 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Intestinal obstruction	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Intestinal perforation	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Nausea	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Pancreatitis	0.61% 1/165 • Number of events 8 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Pancreatitis acute	0.61% 1/165 • Number of events 3 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Peritonitis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Rectal haemorrhage	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Small intestinal obstruction	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Gastrointestinal disorders Vomiting	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
General disorders Asthenia	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
General disorders Catheter site haematoma	1.8% 3/165 • Number of events 3 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
General disorders Chest pain	2.4% 4/165 • Number of events 5 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
General disorders Impaired healing	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
General disorders Non-cardiac chest pain	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Hepatobiliary disorders Cholecystitis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Hepatobiliary disorders Hepatic steatosis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Immune system disorders Anaphylactic reaction	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Abdominal abscess	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Bronchitis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Bronchitis bacterial	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Cellulitis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Gastroenteritis viral	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Groin abscess	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Influenza	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Pneumonia	4.8% 8/165 • Number of events 11 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Pneumonia staphylococcal	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Post procedural sepsis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Sepsis	1.8% 3/165 • Number of events 3 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Infections and infestations Urosepsis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.61% 1/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Anaemia postoperative	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Aortic injury	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Arterial injury	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Device dislocation	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Femur fracture	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications In-stent arterial restenosis	3.6% 6/165 • Number of events 8 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Incisional hernia	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Postoperative ileus	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Spinal fracture	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Stent occlusion	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Subdural haematoma	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Tendon injury	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Traumatic brain injury	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Urostomy complication	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Injury, poisoning and procedural complications Vascular graft occlusion	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Metabolism and nutrition disorders Acidosis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Metabolism and nutrition disorders Fluid overload	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Metabolism and nutrition disorders Hyperkalaemia	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Metabolism and nutrition disorders Hypoglycaemia	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Metabolism and nutrition disorders Hyponatraemia	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Metabolism and nutrition disorders Obesity	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Musculoskeletal and connective tissue disorders Arthralgia	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Musculoskeletal and connective tissue disorders Arthritis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Musculoskeletal and connective tissue disorders Fistula	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Musculoskeletal and connective tissue disorders Muscular weakness	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Nervous system disorders Brain mass	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Nervous system disorders Carotid artery stenosis	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Nervous system disorders Cerebrovascular accident	1.8% 3/165 • Number of events 3 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Nervous system disorders Encephalopathy	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Nervous system disorders Polyneuropathy	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Nervous system disorders Subarachnoid haemorrhage	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Nervous system disorders Syncope	1.8% 3/165 • Number of events 3 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Nervous system disorders Syncope vasovagal	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Nervous system disorders Transient ischaemic attack	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Psychiatric disorders Depression	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Renal and urinary disorders Calculus ureteric	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Renal and urinary disorders Renal artery occlusion	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Renal and urinary disorders Renal artery stenosis	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Renal and urinary disorders Renal disorder	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Renal and urinary disorders Renal failure	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Renal and urinary disorders Renal failure acute	3.0% 5/165 • Number of events 5 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Renal and urinary disorders Renal failure chronic	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Renal and urinary disorders Renal mass	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Reproductive system and breast disorders Galactorrhoea	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.61% 1/165 • Number of events 3 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 2/165 • Number of events 3 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.2% 2/165 • Number of events 3 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Skin and subcutaneous tissue disorders Psoriasis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Skin and subcutaneous tissue disorders Skin ulcer	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Aortic stenosis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Arterial restenosis	1.2% 2/165 • Number of events 2 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Arterial thrombosis limb	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Femoral arterial stenosis	3.0% 5/165 • Number of events 5 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Femoral artery occlusion	3.0% 5/165 • Number of events 9 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Haemorrhage	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Hypotension	2.4% 4/165 • Number of events 4 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Iliac artery stenosis	4.2% 7/165 • Number of events 9 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Intermittent claudication	4.2% 7/165 • Number of events 9 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Orthostatic hypotension	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Peripheral arterial occlusive disease	3.0% 5/165 • Number of events 5 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Peripheral artery aneurysm	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Peripheral ischaemia	1.2% 2/165 • Number of events 5 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Peripheral vascular disorder	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Subclavian artery stenosis	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.
Vascular disorders Vascular pseudoaneurysm	0.61% 1/165 • Number of events 1 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.

Other adverse events

Measure	Device: ICAST Covered Stent n=165 participants at risk Implantation of ≥ 1 ICAST stent
Vascular disorders Peripheral artery dissection	13.3% 22/165 • Number of events 22 • 1080 Days post-procedure Subjects were encouraged to report AEs spontaneously or in response to general, non-directed questioning.

Additional Information

Elizabeth Bulger, Director of Clinical Affairs

Getinge

Phone: 1-603-864-5368

Email: elizabeth.bulger@getinge.com

Results disclosure agreements

• Principal investigator is a sponsor employee No publication or publicizing of data or results without the Sponsor's prior written permission. Party wishing to publish or publicize will submit proposed manuscript or publication to Sponsor for comment at least 60 days prior to release. Publishing party will make every reasonable attempt to incorporate comments received from Sponsor during 60 day period.The publishing party won't use Sponsor's confidential information in manuscript or publication without the prior written consent of sponsor.
• Publication restrictions are in place

Restriction type: OTHER