Vascular Access Complication
Conditions
Keywords
Femoral Artery puncture
Brief summary
Clinical study in patients undergoing any intervention requiring vascular access to the femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control the vascular access. It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.
Detailed description
Patients will have their puncture closure randomly performed by one of these approved methods: Angio-Seal™ Closure device or Manual Compression. Patients will be enrolled in the study during 12 months, with a follow-up period of 2 weeks (± 1 week). The randomization will be stratified according to the type of procedure.
Interventions
PROCEDUREManual compression
Closure procedure by Manual compression
DEVICEAngio-Seal
Closure procedure by angio-Seal
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient ≥ 18 years Interventional Radiology procedures with Femoral Artery puncture (4 French - 8 French Introducers) * Patient available for follow-up at 2 weeks * Patients who are willing to participate and have signed an Ethic Committee approved patient informed consent.
Exclusion criteria
* Access unsuitable for use of Angio-Sea * Presence of calcification at the puncture site * Presence of visible hematoma at the end of the procedure * Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason. * Patients who are pregnant. * Patients currently participating in a clinical investigation that includes an active treatment arm. * Contraindication for ambulation at 2 hours after the end of the procedure * Patients with a life expectancy of less then 1 month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Mobilization Time Between 0-4 Hours | At discharge | Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Any Complications | At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week) | Number of patients with any complications since the puncture closure until 2 weeks ± 1 week. The complications are related to the puncture closure evaluated at closure, discharge and follow-up. These include hematoma, Inferior limb ischemia, prolonged pain at puncture site, puncture site local infection, pseudoaneurysm, significant bleeding and vessel occlusion. |
| Number of Patients With Time to Hemostasis Between 0-4 Minutes | At puncture closure | Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding. |
| Number of Patients With Mobilization Time Between 4-48 Hours | At discharge | Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk. |
| Time to Discharge From Interventional Radiology Department | At discharge | Time that the physician grants the patient the discharge order from the Radiology Department. If the patients has order to be hospitalized up to 24h after the puncture closure by the radiologist, then, the discharge from the radiology department will be 24h, even if the patient needs to continue hospitalized in other department. |
| Percentage of Patients With Angio-Seal™ Deployment Success | At puncture closure | According the physician criteria, it will be YES If the anchor was deliver properly, the absorbable component remain in the correct point of the arterial puncture and no bleeding in the skin puncture. |
| Number of Patients With Time to Hemostasis Between 4-60 Minutes | At puncture closure | Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding. |
Countries
Portugal, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Angio-Seal Closure procedure by Angio-Seal
Angio-Seal: Closure procedure by angio-Seal | 61 |
| Manual Compression Closure procedure by manual compression
Manual compression: Closure procedure by Manual compression | 62 |
| Total | 123 |
Baseline characteristics
| Characteristic | Angio-Seal | Manual Compression | Total |
|---|---|---|---|
| Age, Continuous | 60.77 years STANDARD_DEVIATION 15.15 | 60.92 years STANDARD_DEVIATION 13.55 | 60.84 years STANDARD_DEVIATION 14.32 |
| Sex: Female, Male Female | 22 Participants | 17 Participants | 39 Participants |
| Sex: Female, Male Male | 39 Participants | 45 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 61 | 2 / 62 |
| serious Total, serious adverse events | 3 / 61 | 6 / 62 |
Outcome results
Primary
Number of Patients With Mobilization Time Between 0-4 Hours
Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.
Time frame: At discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angio-Seal | Number of Patients With Mobilization Time Between 0-4 Hours | 52 participants |
| Manual Compression | Number of Patients With Mobilization Time Between 0-4 Hours | 14 participants |
Secondary
Number of Patients With Any Complications
Number of patients with any complications since the puncture closure until 2 weeks ± 1 week. The complications are related to the puncture closure evaluated at closure, discharge and follow-up. These include hematoma, Inferior limb ischemia, prolonged pain at puncture site, puncture site local infection, pseudoaneurysm, significant bleeding and vessel occlusion.
Time frame: At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angio-Seal | Number of Patients With Any Complications | 6 participants |
| Manual Compression | Number of Patients With Any Complications | 6 participants |
Secondary
Number of Patients With Mobilization Time Between 4-48 Hours
Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.
Time frame: At discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angio-Seal | Number of Patients With Mobilization Time Between 4-48 Hours | 9 participants |
| Manual Compression | Number of Patients With Mobilization Time Between 4-48 Hours | 48 participants |
Secondary
Number of Patients With Time to Hemostasis Between 0-4 Minutes
Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding.
Time frame: At puncture closure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angio-Seal | Number of Patients With Time to Hemostasis Between 0-4 Minutes | 54 participants |
| Manual Compression | Number of Patients With Time to Hemostasis Between 0-4 Minutes | 1 participants |
Secondary
Number of Patients With Time to Hemostasis Between 4-60 Minutes
Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding.
Time frame: At puncture closure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angio-Seal | Number of Patients With Time to Hemostasis Between 4-60 Minutes | 7 participants |
| Manual Compression | Number of Patients With Time to Hemostasis Between 4-60 Minutes | 60 participants |
Secondary
Percentage of Patients With Angio-Seal™ Deployment Success
According the physician criteria, it will be YES If the anchor was deliver properly, the absorbable component remain in the correct point of the arterial puncture and no bleeding in the skin puncture.
Time frame: At puncture closure
Population: Only patients in the Angio-Seal arm is analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Angio-Seal | Percentage of Patients With Angio-Seal™ Deployment Success | 95.1 percentage of patients |
Secondary
Time to Discharge From Interventional Radiology Department
Time that the physician grants the patient the discharge order from the Radiology Department. If the patients has order to be hospitalized up to 24h after the puncture closure by the radiologist, then, the discharge from the radiology department will be 24h, even if the patient needs to continue hospitalized in other department.
Time frame: At discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Angio-Seal | Time to Discharge From Interventional Radiology Department | 3.70 hours | Standard Deviation 7.79 |
| Manual Compression | Time to Discharge From Interventional Radiology Department | 3.64 hours | Standard Deviation 9.61 |