Vascular Access Complication
Conditions
Brief summary
This study is a retrospective, single center data collection to assess bleeding and vascular complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral Introducer is used for vascular access.
Detailed description
This study is intended to collect data on the rate of vascular complications in subjects having transfemoral TAVI when the SoloPath® Balloon Expandable TransFemoral Introducer is used as a guide for introduction and delivery of TAVI devices. The use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with TAVI and further enhance the safety of accessing the femoral delivery route. In addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following TAVI.
Interventions
None listed
Sponsors
Montreal Heart Institute
Terumo Medical Corporation
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must have undergone a TAVI procedure with femoral access achieved with a 19Fr (ID) SoloPath (STFI) sheath. 2. Male or female ≥ 18 years old.
Exclusion criteria
1. Subjects with Femoral or Iliac vessels less than 6mm on side of TAVI access will be excluded. 2. Subjects treated before January 1, 2011, are excluded from this analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Access Site Complications | withn 30 days of TAVI procedure | Rate of VARC-2 defined vascular complications within 30 days of TAVI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Complications at the Access Site | within 30 days of TAVI procedure | VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding |
Countries
Canada
Participant flow
Recruitment details
Recruitment occurred between October 7th, 2014 and February 9th, 2015 at the Montreal Heart Institute.
Participants by arm
| Arm | Count |
|---|---|
| SoloPath Sheath The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | SoloPath Sheath |
|---|---|
| Age, Continuous | 83.3 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment Canada | 90 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Vascular Access Site Complications
Rate of VARC-2 defined vascular complications within 30 days of TAVI.
Time frame: withn 30 days of TAVI procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SoloPath Sheath | Vascular Access Site Complications | 17 participants |
Secondary
Bleeding Complications at the Access Site
VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding
Time frame: within 30 days of TAVI procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SoloPath Sheath | Bleeding Complications at the Access Site | 19 participants |