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Low enrollment rate.
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Clinical study in patients undergoing any intervention requiring vascular access to the femoral artery. The study compares Angio-Sealâ„¢ vs. Manual Compression with regard to control the vascular access.
It is designed to demonstrate superiority of the Angio-Sealâ„¢ with an unchanged risk-profile.
Patients will have their puncture closure randomly performed by one of these approved methods: Angio-Sealâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angio-Seal | Active Comparator | Closure procedure by Angio-Seal |
|
| Manual compression | Active Comparator | Closure procedure by manual compression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual compression | Procedure | Closure procedure by Manual compression |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At discharge |
| Number of Patients With Any Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Alberto Mingo, PhD. | Hospital Universitario de La Princesa, Madrid | Principal Investigator |
| Dr. Paolo Morgado, PhD. | Hospital de São João, E.P.E. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de São João, E.P.E. | Porto | 4202-451 | Portugal | |||
| Hospital Universitario de La Princesa |
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| ID | Title | Description |
|---|---|---|
| FG000 | Angio-Seal | Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal |
| FG001 | Manual Compression | Closure procedure by manual compression Manual compression: Closure procedure by Manual compression |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Angio-Seal | Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal |
| BG001 | Manual Compression | Closure procedure by manual compression Manual compression: Closure procedure by Manual compression |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | At discharge |
|
|
2 weeks (+/- 1 week)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Angio-Seal | Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deterioration of general condition | General disorders | Systematic Assessment | DETERIORATION OF THE GENERAL CONDITION OF THIS GERIATRIC PATIENT |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Surgical and medical procedures | Systematic Assessment | BIGGER BRUISE : SMALL HEMATOMA LESS THAN 6 CM SIGNALED BY THE PATIENT |
This study has been early terminated on 15 May 2014 due to low enrollment rate and the publication of other larger studies about closure device versus manual compression.This lead to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paulo Morgado | Hospital de Sao Joao, E.P.E. | +351 22 551 2100 | vilaresmorgado@iol.pt |
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| Angio-Seal |
| Device |
Closure procedure by angio-Seal |
|
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.
| At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week) |
| 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". | At puncture closure |
| 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". | At puncture closure |
| 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. | At discharge |
| Percentage of Patients With Angio-Sealâ„¢ 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. | At puncture closure |
| Madrid |
| 28006 |
| Spain |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| 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. | Posted | Number | participants | At discharge |
|
|
|
| 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. | Posted | Number | participants | At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week) |
|
|
|
| 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". | Posted | Number | participants | At puncture closure |
|
|
|
| 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". | Posted | Number | participants | At puncture closure |
|
|
|
| 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. | Posted | Mean | Standard Deviation | hours | At discharge |
|
|
|
| Secondary | Percentage of Patients With Angio-Sealâ„¢ 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. | Only patients in the Angio-Seal arm is analyzed | Posted | Number | percentage of patients | At puncture closure |
|
|
|
| 3 |
| 61 |
| 7 |
| 61 |
| EG001 | Manual Compression | Closure procedure by manual compression Manual compression: Closure procedure by Manual compression | 6 | 62 | 2 | 62 |
|
| Bleeding | Surgical and medical procedures | Systematic Assessment | BLEEDING OF THE PUNCTURE SITE |
|
| Superficial Perforation femoral artery | Surgical and medical procedures | Systematic Assessment | PERFORATION SUPERFICIAL FEMORAL ARTERY |
|
| Significant bleeding | Surgical and medical procedures | Systematic Assessment | SIGNIFICANT BLEEDING AFTER MANUAL COMPRESSION WITH PROLONGATION OF MANUAL COMPRESSION AND PROLONGED HOSPITAL STAY. |
|
| Hematoma | Surgical and medical procedures | Systematic Assessment | HEMATOMA AFTER 24 HOURS AT PUNCTURE SITE |
|
| Hepatic Abcess | Hepatobiliary disorders | Systematic Assessment | HEPATIC ABSCESS. DISCHARGE ON 3/06/2011 |
|
| Edematoascitis | General disorders | Systematic Assessment | FEVER, EDEMATOASCITIS DECOMPENSATIS, INFERIOR EXTREMITIES CELLULITIS GREATER IN COUNTER LATERAL PUNCTION SITE |
|
| Minor Stroke | Cardiac disorders | Systematic Assessment | MINOR STROKE LEFT SIDE |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment | SERIOUS URINARY TRACT INFECTION IN AN ELDERLY PERSON |
|
| Vessel stenosis | Surgical and medical procedures | Systematic Assessment | PROLONGED PAIN AT THE PUNCTURE SITE. VESSEL STENOSIS |
|
|
| Bleeding | Surgical and medical procedures | Systematic Assessment | FAILURE OF INTRODUCTION OF THE INTRODUCER OF THE ANGIO-SEAL WITH SIGNIFICANT BLEEDING. |
|
| Bruise | Surgical and medical procedures | Systematic Assessment | BIGGER BRUISE OF THE PUNCTURE AREA AND WENT TO A GENERAL PRACTITIONER |
|
| Headache and vomits | Vascular disorders | Systematic Assessment | ACUTE HEADACHE + ONE TIME VOMITING AFTER CAROTID STENTING |
|
| Hematoma | Surgical and medical procedures | Systematic Assessment | HEMATOMA AFTER 5 DAYS OF INTERVENTIONAL PROCEDURE |
|
| Bruise | Surgical and medical procedures | Systematic Assessment | BRUISE IN THE PUNCTION AREA STILL PRESENT AT PHONE CALL VISIT |
|
| Bleeding | Surgical and medical procedures | Systematic Assessment | BLEEDING AFTER CLOSURE PROCEDURE |
|
| Bleeding | Surgical and medical procedures | Systematic Assessment | BLEEDING AFTER CLOTURE PROCEDURE |
|
| Pain | Surgical and medical procedures | Systematic Assessment | SLIGHT PAIN AT PUNCTURE SITE |
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| Hematoma | Surgical and medical procedures | Systematic Assessment | HEMATOMA DURING THE PROCEDURE RELATED TO CALCIFICATION |
|
| Hematoma | Surgical and medical procedures | Systematic Assessment | SMALL HAEMATOMA (+/- 1 CM) |
|
| Pain | Surgical and medical procedures | Systematic Assessment | PAIN IN THE PUNCTURE AREA |
|
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