Trial Outcomes & Findings for Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting (NCT NCT01783639)

NCT ID: NCT01783639

Last Updated: 2017-08-07

Results Overview

Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: Within 30 Days of procedure
• Results posted on: 2017-08-07

Participant Flow

Participant milestones

Measure	WIRION Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
Overall Study STARTED	120
Overall Study COMPLETED	120
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting

Baseline characteristics by cohort

Measure	Arm 1 n=120 Participants Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	107 Participants n=5 Participants
Age, Continuous	74.9 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	87 Participants n=5 Participants
Region of Enrollment Belgium	11 participants n=5 Participants
Region of Enrollment Italy	40 participants n=5 Participants
Region of Enrollment Germany	69 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 Days of procedure

Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.

Outcome measures

Measure	Arm 1 n=120 Participants Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.	4 participants Interval 0.9 to 8.3

SECONDARY outcome

Timeframe: Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Defined as freedom from procedure related serious adverse events

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 30 Days of procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 30 Days of procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Successful completion of the protected stent procedure without angiographic complications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of the procedure, an expected average of 35 minutes

Defined as both device and angiographic success

Outcome measures

Outcome data not reported

Adverse Events

WIRION

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	WIRION n=120 participants at risk Device: WIRION™ Embolic Protection System Interventions: Carotid Artery Stent Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
Nervous system disorders Neurological/ Nervous system	5.8% 7/120 • Number of events 7
Cardiac disorders Cardiovascular	3.3% 4/120 • Number of events 4
Blood and lymphatic system disorders Low hemoglobin level	1.7% 2/120 • Number of events 2
Gastrointestinal disorders Severe anemia related to gastrointestinal bleeding	0.83% 1/120 • Number of events 1
General disorders Admission at hospital with pain in segment L5/S1, protrusion of intervertebral discs	0.83% 1/120 • Number of events 1
General disorders Incomplete occulomoric paresis because of hypotension	0.83% 1/120 • Number of events 1
General disorders Macular artery occlusion	0.83% 1/120 • Number of events 1
General disorders Hospitalization due to aphasia and worsening of general health	0.83% 1/120 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vardit Segal

Gardia Medical

Phone: +972-4-6277166

Email: Vardit@Gardiamedical.com

Results disclosure agreements

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

Restriction type: LTE60