A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SoloPath Sheath The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access |
Outcome Measures
Primary Outcome Measures
- Vascular Access Site Complications [withn 30 days of TAVI procedure]
Rate of VARC-2 defined vascular complications within 30 days of TAVI.
Secondary Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montreal Heart Institute | Montreal | Ontario | Canada |
Sponsors and Collaborators
- Terumo Medical Corporation
- Montreal Heart Institute
Investigators
- Principal Investigator: Anita Asagr, M.D., Montreal Heart Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TIS2014-001
Study Results
Participant Flow
| Recruitment Details | Recruitment occurred between October 7th, 2014 and February 9th, 2015 at the Montreal Heart Institute. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | SoloPath Sheath |
|---|---|
| Arm/Group Description | The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access. |
| Period Title: Overall Study | |
| STARTED | 90 |
| COMPLETED | 90 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | SoloPath Sheath |
|---|---|
| Arm/Group Description | The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access |
| Overall Participants | 90 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
83.3
(6.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
46
51.1%
|
| Male |
44
48.9%
|
| Region of Enrollment (participants) [Number] | |
| Canada |
90
100%
|
Outcome Measures
| Title | Vascular Access Site Complications |
|---|---|
| Description | Rate of VARC-2 defined vascular complications within 30 days of TAVI. |
| Time Frame | withn 30 days of TAVI procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SoloPath Sheath |
|---|---|
| Arm/Group Description | Vascular Complications |
| Measure Participants | 90 |
| Number [participants] |
17
18.9%
|
| Title | Bleeding Complications at the Access Site |
|---|---|
| Description | VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding |
| Time Frame | within 30 days of TAVI procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SoloPath Sheath |
|---|---|
| Arm/Group Description | Rate of VARC-2 defined access site bleeding complications. |
| Measure Participants | 90 |
| Number [participants] |
19
21.1%
|
Adverse Events
| Time Frame | Adverse events were not assessed as this was a retrospective study. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | SoloPath Sheath | |
| Arm/Group Description | The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access. | |
All Cause Mortality |
||
| SoloPath Sheath | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| SoloPath Sheath | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| SoloPath Sheath | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Robert Gash, Director of Clinical Affairs |
|---|---|
| Organization | Terumo Medical Corporation |
| Phone | 732-302-4931 |
| robert.gash@terumomedical.com |
- TIS2014-001