AGIR Study: Angio-Seal in Interventional Radiology

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01911403
• Collaborator: (none)
• Enrollment: 123
• Locations: 2
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 61.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication	Procedure: Manual compression; Device: Angio-Seal	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Angio-Seal Closure procedure by Angio-Seal	Device: Angio-Seal; Closure procedure by angio-Seal
Active Comparator: Manual compression Closure procedure by manual compression	Procedure: Manual compression; Closure procedure by Manual compression

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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".

4. 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".

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de São João, E.P.E.	Porto		Portugal	4202-451
2	Hospital Universitario de La Princesa	Madrid		Spain	28006

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Dr. Alberto Mingo, PhD., Hospital Universitario de La Princesa, Madrid
• Principal Investigator: Dr. Paolo Morgado, PhD., Hospital de São João, E.P.E.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01911403
• Other Study ID Numbers: CV08025POVC
• First Posted: Jul 30, 2013
• Last Update Posted: Feb 19, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Abbott Medical Devices: Femoral Artery puncture

Study Results

Participant Flow

Arm/Group Title	Angio-Seal	Manual Compression
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal	Closure procedure by manual compression Manual compression: Closure procedure by Manual compression
Period Title: Overall Study
STARTED	61	62
COMPLETED	52	59
NOT COMPLETED	9	3

Baseline Characteristics

Arm/Group Title	Angio-Seal	Manual Compression	Total
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal	Closure procedure by manual compression Manual compression: Closure procedure by Manual compression	Total of all reporting groups
Overall Participants	61	62	123
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.77 (15.15)	60.92 (13.55)	60.84 (14.32)
Sex: Female, Male (Count of Participants)
Female	22 36.1%	17 27.4%	39 31.7%
Male	39 63.9%	45 72.6%	84 68.3%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Mobilization Time Between 0-4 Hours
Description	Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.
Time Frame	At discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Angio-Seal	Manual Compression
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal	Closure procedure by manual compression Manual compression: Closure procedure by Manual compression
Measure Participants	61	62
Number [participants]	52 85.2%	14 22.6%

2. Secondary Outcome

Title	Number of Patients With Mobilization Time Between 4-48 Hours
Description	Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.
Time Frame	At discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Angio-Seal	Manual Compression
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal	Closure procedure by manual compression Manual compression: Closure procedure by Manual compression
Measure Participants	61	62
Number [participants]	9 14.8%	48 77.4%

3. Secondary Outcome

Title	Number of Patients With Any Complications
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Angio-Seal	Manual Compression
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal	Closure procedure by manual compression Manual compression: Closure procedure by Manual compression
Measure Participants	61	62
Number [participants]	6 9.8%	6 9.7%

4. Secondary Outcome

Title	Number of Patients With Time to Hemostasis Between 0-4 Minutes
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Angio-Seal	Manual Compression
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal	Closure procedure by manual compression Manual compression: Closure procedure by Manual compression
Measure Participants	61	62
Number [participants]	54 88.5%	1 1.6%

5. Secondary Outcome

Title	Number of Patients With Time to Hemostasis Between 4-60 Minutes
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Angio-Seal	Manual Compression
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal	Closure procedure by manual compression Manual compression: Closure procedure by Manual compression
Measure Participants	61	62
Number [participants]	7 11.5%	60 96.8%

6. Secondary Outcome

Title	Time to Discharge From Interventional Radiology Department
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Angio-Seal	Manual Compression
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal	Closure procedure by manual compression Manual compression: Closure procedure by Manual compression
Measure Participants	61	62
Mean (Standard Deviation) [hours]	3.70 (7.79)	3.64 (9.61)

7. Secondary Outcome

Title	Percentage of Patients With Angio-Seal™ Deployment Success
Description	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

Outcome Measure Data

Analysis Population Description

Only patients in the Angio-Seal arm is analyzed

Arm/Group Title	Angio-Seal
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal
Measure Participants	61
Number [percentage of patients]	95.1

Adverse Events

Time Frame	2 weeks (+/- 1 week)
Arm/Group Title	Angio-Seal		Manual Compression
Arm/Group Description	Closure procedure by Angio-Seal Angio-Seal: Closure procedure by angio-Seal		Closure procedure by manual compression Manual compression: Closure procedure by Manual compression
All Cause Mortality
	Angio-Seal		Manual Compression
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Angio-Seal		Manual Compression
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/61 (4.9%)		6/62 (9.7%)
Cardiac disorders
Minor Stroke	1/61 (1.6%)	1	0/62 (0%)	0
General disorders
Deterioration of general condition	0/61 (0%)	0	1/62 (1.6%)	1
Edematoascitis	0/61 (0%)	0	1/62 (1.6%)	1
Hepatobiliary disorders
Hepatic Abcess	0/61 (0%)	0	1/62 (1.6%)	1
Renal and urinary disorders
Urinary Tract Infection	0/61 (0%)	0	1/62 (1.6%)	1
Surgical and medical procedures
Bleeding	0/61 (0%)	0	1/62 (1.6%)	1
Superficial Perforation femoral artery	0/61 (0%)	0	1/62 (1.6%)	1
Significant bleeding	0/61 (0%)	0	1/62 (1.6%)	1
Hematoma	1/61 (1.6%)	1	0/62 (0%)	0
Vessel stenosis	1/61 (1.6%)	1	0/62 (0%)	0
Other (Not Including Serious) Adverse Events
	Angio-Seal		Manual Compression
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/61 (11.5%)		2/62 (3.2%)
Surgical and medical procedures
Hematoma	0/61 (0%)	0	1/62 (1.6%)	1
Bleeding	1/61 (1.6%)	1	0/62 (0%)	0
Bruise	1/61 (1.6%)	1	0/62 (0%)	0
Hematoma	0/61 (0%)	0	1/62 (1.6%)	1
Bruise	1/61 (1.6%)	1	0/62 (0%)	0
Bleeding	1/61 (1.6%)	1	0/62 (0%)	0
Bleeding	1/61 (1.6%)	1	0/62 (0%)	0
Pain	1/61 (1.6%)	1	0/62 (0%)	0
Hematoma	1/61 (1.6%)	1	0/62 (0%)	0
Hematoma	1/61 (1.6%)	1	0/62 (0%)	0
Pain	1/61 (1.6%)	1	0/62 (0%)	0
Vascular disorders
Headache and vomits	1/61 (1.6%)	1	0/62 (0%)	0

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.