N/A
Completed N=90
A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications
Vascular Access Complication
Source: ClinicalTrials.gov NCT02297308 ↗
Enrolled (actual)
90
Serious AEs
—
Results posted
Feb 2016
Primary outcomePrimary: Vascular Access Site Complications — 17 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vascular Access Site Complications |
17 | — |
| SECONDARY Bleeding Complications at the Access Site |
19 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have undergone a TAVI procedure with femoral access achieved with a 19Fr (ID) SoloPath (STFI) sheath.
- Male or female ≥ 18 years old.
Exclusion Criteria
- Subjects with Femoral or Iliac vessels less than 6mm on side of TAVI access will be excluded.
- Subjects treated before January 1, 2011, are excluded from this analysis.
Data sourced from ClinicalTrials.gov (NCT02297308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.