Vascular Closure
Conditions
Brief summary
To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.
Interventions
DEVICEAngio-Seal VIP 6 French (6F) and 8 French (8F) devices
These devices are used for the vascular closure procedure
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient requires closure of femoral artery puncture resulting from arterial access procedure. * Patient is ≥18 years of age. * Patient is willing to provide written informed consent prior to study device use. * Patient is willing and able to adhere to data collection and follow-up requirements.
Exclusion criteria
* Patient is participating in another clinical trial which has the potential to impact hemostasis. * Patient has an active groin infection or systemic infection. * Patient has undergone a vascular access procedure within the past 90 days. * Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment. | within 5 minutes of device deployment | — |
| The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication | 30 days post procedure | Major vascular complications include: Access Site Complications: * Hematoma \>10 cm in size requiring surgical or percutaneous intervention * Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention * Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention * Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics * A/V Fistula requiring medical intervention (percutaneous or surgical) * Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical) |
Countries
Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Angio-Seal VIP Vascular Closure Angio-Seal VIP 6F and 8F devices: These devices are used for the vascular closure procedure | 211 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | No Device Deployment Attempted | 24 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Angio-Seal VIP Vascular Closure |
|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment Germany | 146 participants |
| Region of Enrollment Netherlands | 65 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 145 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 211 |
| serious Total, serious adverse events | 34 / 211 |
Outcome results
Primary
The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.
Time frame: within 5 minutes of device deployment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deployed Subjects | The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment. | 98.6 % of proc. w/hemostasis within 5 min |
Comparison: Ho: St ≤ 90% Ha: St \> 90%, where St is the proportion of deployed subjects achieving hemostasis within 5 minutes.p-value: <0.0001Fisher Exact
Primary
The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication
Major vascular complications include: Access Site Complications: * Hematoma \>10 cm in size requiring surgical or percutaneous intervention * Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention * Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention * Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics * A/V Fistula requiring medical intervention (percutaneous or surgical) * Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)
Time frame: 30 days post procedure
Population: All subjects with device deployments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deployed Subjects | The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication | 2.8 % of subjects with MVCs |
Comparison: Ho: Pt ≥ 8% Ha: Pt \< 8%, where Pt is the proportion of deployed subjects with a protocol-defined vascular complication.p-value: 0.0029Fisher Exact