Diagnostic and/or Interventional Radiology Procedures
Conditions
Keywords
vascular closure, Angio-Seal, Interventional radiology, femoral artery
Brief summary
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.
Interventions
None listed
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device. 2. Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.
Exclusion criteria
1\. Patients who are unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Vascular Complications | 30 days | Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure. The following are defined as a major vascular complication: 1. Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means; 2. Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention; 3. Access site related bleeding requiring transfusion; 4. New ipsilateral lower extremity ischemia requiring surgical intervention; 5. Retroperitoneal bleeding; 6. Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics; 7. Access related complication that results in extended hospital stay; 8. Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | Procedure | Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved \>5 minutes and/or with additional hemostasis methods required. |
| Rate of Minor Vascular Complications | 30 days | The following are defined as a minor vascular complication: 1. Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis; 2. Ipsilateral hematoma \>10 cm; 3. Ipsilateral pseudoaneurysm without intervention; 4. Ipsilateral arteriovenous fistula; 5. Ipsilateral deep vein thrombosis; 6. Local access site infection without prolonged hospitalization |
| Impact of Guided Access on Use of Closure Device. | 30 days | The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device. |
| Impact of Guided Access on Achieving Target Puncture Location. | 30 days | The influence of fluoroscopy and/or ultrasound guided access on puncture location. |
| Rate of Minor Vascular Complications by Guided Access Mode. | 30 days | The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications. |
| Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device | 30 days | Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device |
| Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device | 30 days | Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved. |
| Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD) | 30 days | Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC). |
| Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD) | 30 days | Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications. |
| Rate of Major Vascular Complications (MVCs) by Guided Access Mode. | 30 days | The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants | 634 |
| Total | 634 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 10 |
| Overall Study | Lost to Follow-up | 37 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 14.2 |
| Region of Enrollment United States | 634 participants |
| Sex: Female, Male Female | 328 Participants |
| Sex: Female, Male Male | 306 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 634 |
| serious Total, serious adverse events | 15 / 634 |
Outcome results
Primary
Rate of Major Vascular Complications
Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure. The following are defined as a major vascular complication: 1. Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means; 2. Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention; 3. Access site related bleeding requiring transfusion; 4. New ipsilateral lower extremity ischemia requiring surgical intervention; 5. Retroperitoneal bleeding; 6. Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics; 7. Access related complication that results in extended hospital stay; 8. Death
Time frame: 30 days
Population: 5 subjects underwent vascular closure with Angio-Seal on right and left sides.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angio -Seal | Rate of Major Vascular Complications | 0.7 Percentage of Procedures |
Secondary
Impact of Guided Access on Achieving Target Puncture Location.
The influence of fluoroscopy and/or ultrasound guided access on puncture location.
Time frame: 30 days
Population: Deployed subjects with readable angiograms
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angio -Seal | Impact of Guided Access on Achieving Target Puncture Location. | Ultrasound only, n=23 participants | 87.0 % within target zone |
| Angio -Seal | Impact of Guided Access on Achieving Target Puncture Location. | Fluoroscopy only, n=240 participants | 81.7 % within target zone |
| Angio -Seal | Impact of Guided Access on Achieving Target Puncture Location. | Both Fluoro and ultrasound, n=113 participants | 77.0 % within target zone |
| Angio -Seal | Impact of Guided Access on Achieving Target Puncture Location. | Neither fluoro nor ultrasound, n=92 participants | 87.0 % within target zone |
Secondary
Impact of Guided Access on Use of Closure Device.
The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.
Time frame: 30 days
Population: Percentage of procedures with devices deployed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angio -Seal | Impact of Guided Access on Use of Closure Device. | Ultrasound only, n=30 procedures | 90.0 % of procedures using a closure device |
| Angio -Seal | Impact of Guided Access on Use of Closure Device. | Fluorscopy only, n=309 procedures | 86.7 % of procedures using a closure device |
| Angio -Seal | Impact of Guided Access on Use of Closure Device. | Fluoro and ultrasound, n=144 procedures | 88.2 % of procedures using a closure device |
| Angio -Seal | Impact of Guided Access on Use of Closure Device. | Neither fluoro nor ultrasound, n=156 procedures | 73.1 % of procedures using a closure device |
Secondary
Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device
Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angio -Seal | Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device | Non-PVD procedures, n=232 | 98.7 % of procedures achieving hemostasis |
| Angio -Seal | Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device | PVD procedures, n=307 | 97.7 % of procedures achieving hemostasis |
Secondary
Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device
Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angio -Seal | Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device | Non-PVD procedures, n=248 | 93.1 % of procedures using closure device |
| Angio -Seal | Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device | PVD procedures, n=391 | 78.0 % of procedures using closure device |
Secondary
Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)
Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angio -Seal | Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD) | Non-PVD procedures, n=232 | 0.4 % of procedures with MVCs |
| Angio -Seal | Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD) | PVD procedures, n=307 | 1 % of procedures with MVCs |
Secondary
Rate of Major Vascular Complications (MVCs) by Guided Access Mode.
The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angio -Seal | Rate of Major Vascular Complications (MVCs) by Guided Access Mode. | Ultrasound only, n=27 procedures | 0 % of procedures with MVCs |
| Angio -Seal | Rate of Major Vascular Complications (MVCs) by Guided Access Mode. | Fluoroscopy only, n=269 procedures | 1.1 % of procedures with MVCs |
| Angio -Seal | Rate of Major Vascular Complications (MVCs) by Guided Access Mode. | Fluoro and ultrasound, n=128 procedures | 0.8 % of procedures with MVCs |
| Angio -Seal | Rate of Major Vascular Complications (MVCs) by Guided Access Mode. | Neither fluoro nor ultrasound, n=115 procedures | 0 % of procedures with MVCs |
Secondary
Rate of Minor Vascular Complications
The following are defined as a minor vascular complication: 1. Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis; 2. Ipsilateral hematoma \>10 cm; 3. Ipsilateral pseudoaneurysm without intervention; 4. Ipsilateral arteriovenous fistula; 5. Ipsilateral deep vein thrombosis; 6. Local access site infection without prolonged hospitalization
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angio -Seal | Rate of Minor Vascular Complications | 0.7 % of procedures with minor vasc comp. |
Secondary
Rate of Minor Vascular Complications by Guided Access Mode.
The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angio -Seal | Rate of Minor Vascular Complications by Guided Access Mode. | Ultrasound only, n=27 procedures | 0 % of procedures with minor vasc comp. |
| Angio -Seal | Rate of Minor Vascular Complications by Guided Access Mode. | Fluoroscopy only, n=269 procedures | 0.7 % of procedures with minor vasc comp. |
| Angio -Seal | Rate of Minor Vascular Complications by Guided Access Mode. | Fluoro and ultrasound, n=128 procedures | 1.6 % of procedures with minor vasc comp. |
| Angio -Seal | Rate of Minor Vascular Complications by Guided Access Mode. | Neither fluoro nor ultrasound, n=115 procedures | 0 % of procedures with minor vasc comp. |
Secondary
Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)
Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angio -Seal | Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD) | Non-PVD procedures, n=232 | 1.3 % of procedures with minor vasc comp. |
| Angio -Seal | Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD) | PVD procedures, n=307 | 0.3 % of procedures with minor vasc comp. |
Secondary
Time to Hemostasis
Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved \>5 minutes and/or with additional hemostasis methods required.
Time frame: Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Angio -Seal | Time to Hemostasis | Hemostasis less than 1 minute | 84.9 % of procedures |
| Angio -Seal | Time to Hemostasis | Hemostasis between 1-5 minutes | 13.0 % of procedures |
| Angio -Seal | Time to Hemostasis | Hemostasis greater than 5 minutes | 2.1 % of procedures |