St. Jude Medical Angio-Seal VIP Vascular Closure Device

Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01393041

Enrollment

Registered

2011-07-13

Start date

2011-06-30

Completion date

2011-12-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure

Brief summary

The purpose of this clinical study is to assess device deployment characteristics and performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6 French device utilizing the SJM collagen.

Interventions

DEVICEAngio-Seal VIP

Vascular Closure Device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient is undergoing a diagnostic and/or interventional endovascular procedure via a retrograde femoral arterial access. 2. Patient is of legal age. 3. Patient has given written informed consent for participation prior to the procedure. 4. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.

Exclusion criteria

1. Patient is unable to provide written informed consent. 2. Patient has an inability or is unwilling to adhere to data collection and follow-up requirements. 3. Patients who are pregnant or lactating. 4. Patient may not participate in another clinical trial which has the potential to impact hemostasis (pharmaceutical/ device/ homeopathic).

Design outcomes

Primary

Measure	Time frame	Description
Device deployment characteristics and performance	At procedure	Device Deployment Success and rationale for non-deployment, procedural circumstances present during deployment such as type of procedure and procedure duration, Time to hemostasis, and assessment of vascular complications prior to leaving the cath lab. Data will be summarized using descriptive statistics in addition to listings or summary data tables being provided.
Adverse events (vascular complications)	Ongoing	Adverse events (vascular complications) out to 30 days post-procedure on patients who have undegone a diagnostic and/or interventional procedure.

Secondary

Measure	Time frame
Time to hemostasis	The time elapsed from device deployment (cutting of the suture) to complete cessation of arterial bleeding, stratified as hemostasis in less than 1 minute, 1-5 minutes, or greater than 5 minutes.
Rate of minor vascular complications	Ongoing

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026