Trial Outcomes & Findings for Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device (NCT NCT01858636)

Last Updated: 2019-02-05

Results Overview

Major vascular complications include: Access Site Complications: * Hematoma \>10 cm in size requiring surgical or percutaneous intervention * Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention * Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention * Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics * A/V Fistula requiring medical intervention (percutaneous or surgical) * Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)

Recruitment status

COMPLETED

Target enrollment

235 participants

Primary outcome timeframe

30 days post procedure

Results posted on

2019-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Angio-Seal VIP Vascular Closure Angio-Seal VIP 6 French (6F) and 8 French (8F) devices: These devices are used for the vascular closure procedure
Overall Study STARTED	235
Overall Study Device Deployment	211
Overall Study COMPLETED	207
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Angio-Seal VIP Vascular Closure Angio-Seal VIP 6 French (6F) and 8 French (8F) devices: These devices are used for the vascular closure procedure
Overall Study No Device Deployment Attempted	24
Overall Study Physician Decision	1
Overall Study Death	1
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Angio-Seal VIP Vascular Closure n=211 Participants Angio-Seal VIP 6F and 8F devices: These devices are used for the vascular closure procedure
Age, Continuous	66.6 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	145 Participants n=5 Participants
Region of Enrollment Germany	146 participants n=5 Participants
Region of Enrollment Netherlands	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

Population: All subjects with device deployments.

Outcome measures

Outcome measures
Measure	Deployed Subjects n=211 Participants Percentage of subjects who experienced a major vascular complication during 30-days post procedure.
The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication	2.8 % of subjects with MVCs Interval to 5.5 Per protocol, a one sided Fischer Exact test was performed. As a result, a lower confidence bound is not available.

PRIMARY outcome

Timeframe: within 5 minutes of device deployment

Outcome measures

Outcome measures
Measure	Deployed Subjects n=213 Procedures Percentage of subjects who experienced a major vascular complication during 30-days post procedure.
The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.	98.6 % of proc. w/hemostasis within 5 min Interval 96.4 to Per protocol, a one sided Fischer Exact test was performed. As a result an upper confidence bound is not available.

Adverse Events

Deployed Subjects

Serious events: 34 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Deployed Subjects n=211 participants at risk Adverse Events (AEs) are provided for all subjects that underwent a study device deployment.
Cardiac disorders Coronary Artery Disease	1.9% 4/211 • Number of events 4 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders VASC bleeding	1.9% 4/211 • Number of events 4 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders VASC pseudoaneurysm	1.9% 4/211 • Number of events 4 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders Vascular Hematoma	1.9% 4/211 • Number of events 4 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Aortic Valve Stenosis	1.4% 3/211 • Number of events 3 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Infections and infestations Bacterial Infection	1.4% 3/211 • Number of events 3 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Atrial Fibrillation	0.95% 2/211 • Number of events 3 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders Aortic Aneurysm	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders Vascular Disection	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Gastrointestinal disorders Abdominal Pain	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Cardiomyopathy	0.47% 1/211 • Number of events 2 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Angina Pectoris	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Decreased Left Ventricular Function	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Elective Cardiac Surgery	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Renal and urinary disorders Hematuria	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders Intracerebral Hemorrhage	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders Ischemic Stroke	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Myocardial Infarction	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Sick Sinus Syndrome	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Sustained Ventricular Tachycardia	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Cardiac disorders Tachycardia	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Renal and urinary disorders Urinary Tract Infection	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events

Other adverse events

Other adverse events
Measure	Deployed Subjects n=211 participants at risk Adverse Events (AEs) are provided for all subjects that underwent a study device deployment.
Vascular disorders VASC bruise	8.1% 17/211 • Number of events 17 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders VASC hematoma	3.8% 8/211 • Number of events 9 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders VASC bleeding	2.4% 5/211 • Number of events 5 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events
Vascular disorders VASC pain	0.47% 1/211 • Number of events 1 • 30 days A summary of all ADEs, Serious Adverse Events (SAEs), and non-serious vascular events

Additional Information

Andrew Campbell

St. Jude Medical

Phone: +1.651.756.5538

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place