Trial Outcomes & Findings for A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications (NCT NCT02297308)
NCT ID: NCT02297308
Last Updated: 2016-02-18
Results Overview
Rate of VARC-2 defined vascular complications within 30 days of TAVI.
COMPLETED
90 participants
withn 30 days of TAVI procedure
2016-02-18
Participant Flow
Recruitment occurred between October 7th, 2014 and February 9th, 2015 at the Montreal Heart Institute.
Participant milestones
| Measure |
SoloPath Sheath
The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications
Baseline characteristics by cohort
| Measure |
SoloPath Sheath
n=90 Participants
The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access
|
|---|---|
|
Age, Continuous
|
83.3 years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
90 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: withn 30 days of TAVI procedureRate of VARC-2 defined vascular complications within 30 days of TAVI.
Outcome measures
| Measure |
SoloPath Sheath
n=90 Participants
Vascular Complications
|
|---|---|
|
Vascular Access Site Complications
|
17 participants
|
SECONDARY outcome
Timeframe: within 30 days of TAVI procedureVARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding
Outcome measures
| Measure |
SoloPath Sheath
n=90 Participants
Vascular Complications
|
|---|---|
|
Bleeding Complications at the Access Site
|
19 participants
|
Adverse Events
SoloPath Sheath
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Gash, Director of Clinical Affairs
Terumo Medical Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall be permitted to publish the results of the study in a manner that fairly and accurately sets forth the conclusions reached. The party seeking publication shall submit to the sponsor for review a draft of the proposed publication at least thirty (30) days prior to submission of the draft for publication.
- Publication restrictions are in place
Restriction type: OTHER