Surgical Wound
Conditions
Keywords
Vessel closure, Antegrade access, Femoral arteriotomy, Peripheral endovascular interventions
Brief summary
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths via an antegrade approach.
Detailed description
Due to the growing adoption of antegrade femoral access and the use of VCDs to close these arteriotomies, it is important to collect performance and complication outcomes data related to this procedural variable. The aim of this registry is to consistently collect prospective data on procedural outcomes on antegrade access cases closed with the VASCADE VCS in a way that is consistent with the RESPECT Study design and the FDA-approved Instructions for Use (IFU).
Interventions
DEVICECardiva Medical VASCADE VCS
At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis.
Sponsors
Cardiva Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Acceptable candidate for post-procedural manual compression * Able to ambulate at least 20 feet, with or without assistance
Exclusion criteria
* Active systemic or cutaneous infection or inflammation * Ipsilateral femoral arteriotomy with any of the following conditions: a) access within \< or = 10 days; b) any residual hematoma, significant bruising, or known associated vascular complications; or c) within \< or = 90 days, use of an intra-vascular closure device (i.e., Angioseal) * Previous vascular grafts or surgery at the target vessel access site * Major amputation of ipsilateral lower extremity - previous history of, or planned within next 30 days prior to study exit * Extreme morbid obesity (BMI greater than 4 kg/m2) or underweight (BMI less than 20 kg/m2) * Femoral arterial diameter \< 6 mm at access site * Antegrade arterial access site is a side stick and/or is not a single anterior wall femoral puncture * Length of tissue tract, the distance between the anterior arterial wall and skin, is \< 2.5 cm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis (TTH) | Procedural, usually within 15 minutes of enrollment | Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis. |
| Major Access Site Closure-related Complications | Through 30 days +/- 7 days | Patient incident rate of combined major access site closure-related complications through 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Procedural, usually within 15 minutes of enrollment | Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression. |
| Time to Ambulation (TTA) | Prior to discharge, usually within 24 hours | Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site. |
| Minor Access Site Closure-related Complications | Through 30 +/- 7 days | Patient incident rate of combined minor access site closure-related complications through 30 days |
| Procedure Success | Through 30 +/- 7 days | Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days. |
| Time to Discharge (TTD) | Through hospital discharge, usually within 24 hours | Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VASCADE VCS The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach. | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | VASCADE VCS |
|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 9.86 |
| BMI (Body Mass Index) | 28.3 kg/m^2 STANDARD_DEVIATION 4.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 11 / 52 |
| serious Total, serious adverse events | 2 / 52 |
Outcome results
Primary
Major Access Site Closure-related Complications
Patient incident rate of combined major access site closure-related complications through 30 days
Time frame: Through 30 days +/- 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VASCADE VCS | Major Access Site Closure-related Complications | 1 Participants |
Primary
Time to Hemostasis (TTH)
Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.
Time frame: Procedural, usually within 15 minutes of enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VASCADE VCS | Time to Hemostasis (TTH) | 5.87 minutes | Standard Deviation 2.44 |
Secondary
Device Success
Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression.
Time frame: Procedural, usually within 15 minutes of enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VASCADE VCS | Device Success | 51 Participants |
Secondary
Minor Access Site Closure-related Complications
Patient incident rate of combined minor access site closure-related complications through 30 days
Time frame: Through 30 +/- 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VASCADE VCS | Minor Access Site Closure-related Complications | 51 Participants |
Secondary
Procedure Success
Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.
Time frame: Through 30 +/- 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VASCADE VCS | Procedure Success | 50 Participants |
Secondary
Time to Ambulation (TTA)
Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site.
Time frame: Prior to discharge, usually within 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VASCADE VCS | Time to Ambulation (TTA) | 4.48 hours | Standard Deviation 3.83 |
Secondary
Time to Discharge (TTD)
Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.
Time frame: Through hospital discharge, usually within 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VASCADE VCS | Time to Discharge (TTD) | 5.97 hours | Standard Deviation 5.85 |