Trial Outcomes & Findings for Self-Centering Guide Catheter Feasibility Study (NCT NCT02639494)

Results Overview

This outcome will be assessed via physician determination and will be recorded in the case report form.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Through study completion, up to 72 hours post-procedure

Results posted on

2018-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Self-Centering Guide Catheter Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-Centering Guide Catheter Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Self-Centering Guide Catheter n=20 Participants Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Age, Continuous	78.0 years STANDARD_DEVIATION 9.04 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, up to 72 hours post-procedure

Population: 20 patients were treated with 23 devies

This outcome will be assessed via physician determination and will be recorded in the case report form.

Outcome measures

Outcome measures
Measure	Self-Centering Guide Catheter n=23 Device Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle	18 Device

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, up to 72 hours post-procedure

Population: A guide wire was delivered through the self-centering guide catheter in 18/20 patients.

Outcome measures

Outcome measures
Measure	Self-Centering Guide Catheter n=18 Participants Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve	3.8 minutes Interval 2.7 to 4.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, up to 72 hours post-procedure

Population: A guide wire was delivered through the self-centering guide catheter in 18/20 patients. In total 23 devices were used.

Outcome measures

Outcome measures
Measure	Self-Centering Guide Catheter n=23 Devices Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body	6.6 minutes Interval 4.4 to 8.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, up to 72 hours post-procedure

Outcome measures

Outcome measures
Measure	Self-Centering Guide Catheter n=23 Device Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire	5.1 Attempts Interval 3.2 to 7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, up to 72 hours post-procedure

The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form.

Outcome measures

Outcome measures
Measure	Self-Centering Guide Catheter n=23 Device Subjects who provided written informed consent and an attempt was made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System	23 Device

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, up to 72 hours post-procedure

Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system. This outcome will be assessed via physician determination and will be recorded in the case report form.