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

Abbott Medical Devices235 enrolled

Overview

To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.

Study Type

OBSERVATIONAL

Enrollment

235

Conditions

Vascular Closure

Interventions

Angio-Seal VIP 6 French (6F) and 8 French (8F) devicesDEVICE

These devices are used for the vascular closure procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient requires closure of femoral artery puncture resulting from arterial access procedure. * Patient is ≥18 years of age. * Patient is willing to provide written informed consent prior to study device use. * Patient is willing and able to adhere to data collection and follow-up requirements. Exclusion Criteria: * Patient is participating in another clinical trial which has the potential to impact hemostasis. * Patient has an active groin infection or systemic infection. * Patient has undergone a vascular access procedure within the past 90 days. * Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)

Locations (6)

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany

Institut für Diagnostiche und Interventionelle Radiologie

Frankfurt, Germany

Univ. des Saarlandes

Homburg, Germany

Herzzentrum Leipzig GMBH

Leipzig, Germany

Outcomes

Primary Outcomes

The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication

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)

Time frame: 30 days post procedure

The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.

Time frame: within 5 minutes of device deployment

Data from ClinicalTrials.gov

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