Trial Outcomes & Findings for A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries (NCT NCT00349908)

NCT ID: NCT00349908

Last Updated: 2014-06-30

Results Overview

Successful placement of the product assessed immediately post procedure

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: post procedure
• Results posted on: 2014-06-30

Participant Flow

Patients were recruited at 1 hospital in Argentina in 2006 and 2007 and treated with Codman Neurovascular Self-Expanding Stent System.

This is a device study, there was no wash out or run-in phase for transition.

Participant milestones

Measure	Aneurysm Arm Intracranial wide-necked aneurysms	Atherosclerosis Arm Symptomatic stenosis in intracranial arteries
Overall Study STARTED	10	10
Overall Study COMPLETED	10	6
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Measure	Aneurysm Arm Intracranial wide-necked aneurysms	Atherosclerosis Arm Symptomatic stenosis in intracranial arteries
Overall Study Withdrawal by Subject	0	4

Baseline Characteristics

A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries

Baseline characteristics by cohort

Measure	Aneurysm Arm n=10 Participants Intracranial wide-necked aneurysms	Atherosclerosis Arm n=10 Participants Symptomatic stenosis in intracranial arteries	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 9.0 • n=5 Participants	63.7 years STANDARD_DEVIATION 9 • n=7 Participants	63.85 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Argentina	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: post procedure

Successful placement of the product assessed immediately post procedure

Outcome measures

Measure	Group 1 n=10 Participants Atherosclerosis Arm	Group 2 n=10 Participants Aneurysm Arm
Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)	100 percentage of stable placement 47.3 • Interval 0.0 to 100.0	90 percentage of stable placement 14.7 • Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: post procedure

Population: Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.

Occlusion evaluated immediately post procedure

Outcome measures

Measure	Group 1 Atherosclerosis Arm	Group 2 n=10 Participants Aneurysm Arm
Technical Feasibility- Percent Occlusion (Post Procedure)	—	86.8 percent occlusion Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: 6 mo

Population: Group 1 - Atherosclerosis Arm not analyzed for occlusion. Occlusion only relevant in Aneurysm treatment.

6 Months post

Outcome measures

Measure	Group 1 Atherosclerosis Arm	Group 2 n=10 Participants Aneurysm Arm
Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)	—	88.8 percent occlusion Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: 6 mo

Successful stent/coil placement assessed at 6 mo post

Outcome measures

Measure	Group 1 n=10 Participants Atherosclerosis Arm	Group 2 n=10 Participants Aneurysm Arm
Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)	100 Percentage of stable stent/coil placemen	100 Percentage of stable stent/coil placemen

PRIMARY outcome

Timeframe: 6 mo

Population: Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.

Percent Stenosis assessed 6 mo Post Procedure from pre-procedure

Outcome measures

Measure	Group 1 n=6 Participants Atherosclerosis Arm	Group 2 Aneurysm Arm
Technical Feasibility- Percent Stenosis (6 mo Post Procedure)	-47.3 Percentage change from PreProcedure Standard Deviation 21.2	—

PRIMARY outcome

Timeframe: Post Procedure

Population: Group 2 - Aneurysm Arm not analyzed for stenosis. Stenosis only relevant in Atherosclerosis treatment.

Percent Stenosis assessed immediately post procedure from pre procedure

Outcome measures

Measure	Group 1 n=10 Participants Atherosclerosis Arm	Group 2 Aneurysm Arm
Technical Feasibility- Percent Stenosis (Post Procedure)	-38.5 Percentage Change from PreProcedure Standard Deviation 18.3	—

SECONDARY outcome

Timeframe: 6 months

Population: Group 1 and Group 2 were analyzed separately. In group 1 Atherosclerosis, 25 unique adverse events were reported in 8 of the 10 eligible subjects. In group 2 aneurysm, 28 unique adverse events were reported in 9 of the 10 eligible subjects.

An adverse event was defined as any untoward medical occurrence in a subject.

Outcome measures

Measure	Group 1 n=10 Participants Atherosclerosis Arm	Group 2 n=10 Participants Aneurysm Arm
The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.	25 Number of adverse events	28 Number of adverse events

Adverse Events

Group 1: Atherosclerosis Arm

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Group 2: Aneurysm Arm

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: Atherosclerosis Arm n=10 participants at risk This is the events from the Atherosclerosis Arm	Group 2: Aneurysm Arm n=10 participants at risk This is the events from the Aneurysm Arm
Cardiac disorders Myocardial Infarction	100.0% 1/1 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Respiratory, thoracic and mediastinal disorders Lung Tumor	100.0% 1/1 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Nervous system disorders Ischemic Stroke	100.0% 1/1 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Musculoskeletal and connective tissue disorders Hip Fracture	100.0% 1/1 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Nervous system disorders Stroke/CVA: Ischemic stroke	100.0% 1/1 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Vascular disorders Other: Primitive Left Carotid Ligation	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Vascular disorders Neurological Deficit: left hemianes-thesia and cranial nerve X1 palsy	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Gastrointestinal disorders Other: Gastritis	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.

Other adverse events

Measure	Group 1: Atherosclerosis Arm n=10 participants at risk This is the events from the Atherosclerosis Arm	Group 2: Aneurysm Arm n=10 participants at risk This is the events from the Aneurysm Arm
Nervous system disorders Headache	30.0% 3/10 • Number of events 3 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	80.0% 8/10 • Number of events 8 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Nervous system disorders Hematoma	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Blood and lymphatic system disorders Hypo-Hypertension	30.0% 3/10 • Number of events 3 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Nervous system disorders Ischemia	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Nervous system disorders Myocardial Infarction	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Nervous system disorders Stroke/CVA	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Musculoskeletal and connective tissue disorders Other: Back Pain	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Respiratory, thoracic and mediastinal disorders Other: Bronchitis	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Nervous system disorders Other: Confusion	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Gastrointestinal disorders Other: Diarrhea	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Blood and lymphatic system disorders Other: Elevated Blood Glucose	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Musculoskeletal and connective tissue disorders Other: Hip Fracture	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
General disorders Other: Insomnia	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Respiratory, thoracic and mediastinal disorders Other: Lung Tumor	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
General disorders Other: Nausea	20.0% 2/10 • Number of events 2 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Musculoskeletal and connective tissue disorders Other: Postural Pain	20.0% 2/10 • Number of events 2 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Nervous system disorders Other: Psychomotor excitation	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
General disorders Other: Tiredness	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Renal and urinary disorders Other: Urinary retention	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
General disorders Fever	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Vascular disorders Hematoma	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Blood and lymphatic system disorders Hemorrhage	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Vascular disorders Neurological Deficit	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	20.0% 2/10 • Number of events 2 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Vascular disorders Seizures	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Vascular disorders Stent Migration/Embolization	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Musculoskeletal and connective tissue disorders Other: Cervical, Dorsal, and/or Lumbar Pain	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Eye disorders Other: Eye Pain Sensation	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Gastrointestinal disorders Other: Gastritis	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Eye disorders Other: Photophoby	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Renal and urinary disorders Other: Polyuria	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
Vascular disorders Other: Primitive Left Carotid Ligation	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	10.0% 1/10 • Number of events 1 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.
General disorders Other: Vomiting	0.00% 0/10 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.	20.0% 2/10 • Number of events 2 • From the time the informed consent was signed, AEs were assessed after the procedure, at discharge, at thirty days and six months after treatment. For all enrolled subjects, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge. For subjects with a deployed stent, incidence of AEs assessed immediately following the pre-procedure angiogram through hospital discharge, at thirty days and six months after treatment.

Additional Information

J. Thomas Megerian, MD

Codman & Shurtleff

Phone: 508.828.8274

Email: jmegerian1@its.jnj.com

Results disclosure agreements

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

Restriction type: LTE60