Trial Outcomes & Findings for Angio-Seal Interventional Radiology (IR) Registry (NCT NCT01222104)

NCT ID: NCT01222104

Last Updated: 2019-02-05

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 634 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2019-02-05

Participant Flow

Participant milestones

Measure	All Participants
Overall Study STARTED	634
Overall Study Angio-Seal Deployment Attempted	534
Overall Study Successful Deployment	529
Overall Study Successful Deployment and Hemostasis	524
Overall Study Completed 30-day Visit-Angio-Seal	497
Overall Study Completed 30-day Visit-No Angio-Seal	90
Overall Study COMPLETED	587
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Measure	All Participants
Overall Study Lost to Follow-up	37
Overall Study Death	10

Baseline Characteristics

Angio-Seal Interventional Radiology (IR) Registry

Baseline characteristics by cohort

Measure	All Participants n=634 Participants
Age, Continuous	59.6 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	328 Participants n=5 Participants
Sex: Female, Male Male	306 Participants n=5 Participants
Region of Enrollment United States	634 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: 5 subjects underwent vascular closure with Angio-Seal on right and left sides.

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

Outcome measures

Measure	Angio -Seal n=539 Procedures Angio-Seal attempted and/or deployed group
Rate of Major Vascular Complications	0.7 Percentage of Procedures

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Angio -Seal n=529 Procedures Angio-Seal attempted and/or deployed group
Time to Hemostasis Hemostasis less than 1 minute	84.9 % of procedures
Time to Hemostasis Hemostasis between 1-5 minutes	13.0 % of procedures
Time to Hemostasis Hemostasis greater than 5 minutes	2.1 % of procedures

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Angio -Seal n=539 Procedures Angio-Seal attempted and/or deployed group
Rate of Minor Vascular Complications	0.7 % of procedures with minor vasc comp.

SECONDARY outcome

Timeframe: 30 days

Population: Percentage of procedures with devices deployed

The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.

Outcome measures

Measure	Angio -Seal n=639 Procedures Angio-Seal attempted and/or deployed group
Impact of Guided Access on Use of Closure Device. Ultrasound only, n=30 procedures	90.0 % of procedures using a closure device
Impact of Guided Access on Use of Closure Device. Fluorscopy only, n=309 procedures	86.7 % of procedures using a closure device
Impact of Guided Access on Use of Closure Device. Fluoro and ultrasound, n=144 procedures	88.2 % of procedures using a closure device
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 outcome

Timeframe: 30 days

Population: Deployed subjects with readable angiograms

The influence of fluoroscopy and/or ultrasound guided access on puncture location.

Outcome measures

Measure	Angio -Seal n=468 Participants Angio-Seal attempted and/or deployed group
Impact of Guided Access on Achieving Target Puncture Location. Ultrasound only, n=23 participants	87.0 % within target zone
Impact of Guided Access on Achieving Target Puncture Location. Fluoroscopy only, n=240 participants	81.7 % within target zone
Impact of Guided Access on Achieving Target Puncture Location. Both Fluoro and ultrasound, n=113 participants	77.0 % within target zone
Impact of Guided Access on Achieving Target Puncture Location. Neither fluoro nor ultrasound, n=92 participants	87.0 % within target zone

SECONDARY outcome

Timeframe: 30 days

The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).

Outcome measures

Measure	Angio -Seal n=539 Procedures Angio-Seal attempted and/or deployed group
Rate of Major Vascular Complications (MVCs) by Guided Access Mode. Ultrasound only, n=27 procedures	0 % of procedures with MVCs
Rate of Major Vascular Complications (MVCs) by Guided Access Mode. Fluoroscopy only, n=269 procedures	1.1 % of procedures with MVCs
Rate of Major Vascular Complications (MVCs) by Guided Access Mode. Fluoro and ultrasound, n=128 procedures	0.8 % of procedures with MVCs
Rate of Major Vascular Complications (MVCs) by Guided Access Mode. Neither fluoro nor ultrasound, n=115 procedures	0 % of procedures with MVCs

SECONDARY outcome

Timeframe: 30 days

The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.

Outcome measures

Measure	Angio -Seal n=539 Procedures Angio-Seal attempted and/or deployed group
Rate of Minor Vascular Complications by Guided Access Mode. Ultrasound only, n=27 procedures	0 % of procedures with minor vasc comp.
Rate of Minor Vascular Complications by Guided Access Mode. Fluoroscopy only, n=269 procedures	0.7 % of procedures with minor vasc comp.
Rate of Minor Vascular Complications by Guided Access Mode. Fluoro and ultrasound, n=128 procedures	1.6 % of procedures with minor vasc comp.
Rate of Minor Vascular Complications by Guided Access Mode. Neither fluoro nor ultrasound, n=115 procedures	0 % of procedures with minor vasc comp.

SECONDARY outcome

Timeframe: 30 days

Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device

Outcome measures

Measure	Angio -Seal n=639 Procedures Angio-Seal attempted and/or deployed group
Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device Non-PVD procedures, n=248	93.1 % of procedures using closure device
Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device PVD procedures, n=391	78.0 % of procedures using closure device

SECONDARY outcome

Timeframe: 30 days

Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.

Outcome measures

Measure	Angio -Seal n=539 Procedures Angio-Seal attempted and/or deployed group
Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device Non-PVD procedures, n=232	98.7 % of procedures achieving hemostasis
Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device PVD procedures, n=307	97.7 % of procedures achieving hemostasis

SECONDARY outcome

Timeframe: 30 days

Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).

Outcome measures

Measure	Angio -Seal n=539 Procedures Angio-Seal attempted and/or deployed group
Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD) PVD procedures, n=307	1 % of procedures with MVCs
Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD) Non-PVD procedures, n=232	0.4 % of procedures with MVCs

SECONDARY outcome

Timeframe: 30 days

Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.

Outcome measures

Measure	Angio -Seal n=539 Procedures Angio-Seal attempted and/or deployed group
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.
Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD) PVD procedures, n=307	0.3 % of procedures with minor vasc comp.

Adverse Events

All Participants

Serious events: 15 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=634 participants at risk
Vascular disorders Vascular injury requiring repair via surgery or other means	0.32% 2/634 • 30 days
Vascular disorders New ipsilateral lower extremity ischemia requiring intervention	0.16% 1/634 • 30 days
Gastrointestinal disorders Retroperitoneal bleeding	0.32% 2/634 • 30 days
General disorders Death	1.6% 10/634 • 30 days

Other adverse events

Measure	All Participants n=634 participants at risk
Vascular disorders Ipsilateral hematoma >10cm	0.63% 4/634 • 30 days

Additional Information

Andrew Campbell

St Jude Medical

Phone: 651-756-5538

Email: acampbell2@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60