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Trial Outcomes & Findings for Evaluation of WIRION™ EPS in Lower Extremities Arteries (NCT NCT02780349)

NCT ID: NCT02780349

Last Updated: 2018-03-15

Results Overview

MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

30 days

Results posted on

2018-03-15

Participant Flow

Participant milestones

Participant milestones
Measure
WIRION EPS
WIRION: Embolic Protection System
Overall Study
STARTED
103
Overall Study
COMPLETED
101
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of WIRION™ EPS in Lower Extremities Arteries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Single Arm
n=103 Participants
WIRION: Embolic Protection System
Age, Continuous
68.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male
Female
32 Participants
n=5 Participants
Sex: Female, Male
Male
71 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
93 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
79 participants
n=5 Participants
Region of Enrollment
Germany
24 participants
n=5 Participants

PRIMARY outcome

Timeframe: 30 days

MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)

Outcome measures

Outcome measures
Measure
Single Arm
n=103 Participants
WIRION: Embolic Protection System
Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.
2 Participants

Adverse Events

Single Arm

Serious events: 8 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Single Arm
n=103 participants at risk
WIRION: Embolic Protection System
Cardiac disorders
Hypotension, Hemoglobin drop
0.97%
1/103 • 30 days follow up period
Vascular disorders
Access site complication
0.97%
1/103 • 30 days follow up period
Vascular disorders
Vessel occlusion
0.97%
1/103 • 30 days follow up period
Vascular disorders
TVR
0.97%
1/103 • 30 days follow up period
Vascular disorders
Thrombosis
2.9%
3/103 • 30 days follow up period
Cardiac disorders
Dyspenea
0.97%
1/103 • 30 days follow up period

Other adverse events

Other adverse events
Measure
Single Arm
n=103 participants at risk
WIRION: Embolic Protection System
Vascular disorders
Dissection
8.7%
9/103 • 30 days follow up period

Additional Information

Vardit Segal Ph.D

Gardia Medical

Phone: 972-4-6277166

Results disclosure agreements

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