NCT00388284

Safety and Efficacy Study Comparing Thrombin for Arterial Sealing

Comparative Analysis of Thrombin Utilized in Endovascular Procedures of the Femoral Artery - CEASE Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (planned)
• Sponsor: Vascular Solutions LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is designed as a prospective, multi-center, randomized, double blinded clinical trial to evaluate the safety and efficacy of the Thrombin VSI. An immunological sub-study to assess antibody and coagulation changes in the subjects following exposure to the Vascular Solutions Diagnostic Duett Pro manufactured with Thrombin VSI and Thrombin JMI will be conducted as a component of this trial with a subset of the enrolled study subjects. Two hundred seventy (270) subjects will be enrolled in this trial. A minimum of 50% of the subjects will be interventional subjects and up to 50% will be diagnostic subjects. All 270 subjects will provide blood specimens at baseline and at the 30 day follow-up visit for evaluation in the immunologic sub-study. Within the 270 subjects enrolled, a minimum of 45 subjects treated with the Thrombin VSI and a minimum of 45 subjects treated with the Thrombin JMI will provide blood specimens at the 60 day follow-up visit to be evaluated in the immunologic sub-study. The primary efficacy objective is to demonstrate that the device time-to-hemostasis for the study group treated with the sealing device manufactured with Thrombin VSI is non-inferior to the study group treated with the sealing device manufactured with Thrombin JMI. The primary safety objective is to demonstrate a device-related major complication rate for the study group treated with the sealing device manufactured with Thrombin VSI that is non-inferior to the device-related major complication rate observed for the study group treated with the sealing device manufactured with Thrombin JMI.

Conditions

• Hemostasis of Arterial Punctures

Interventions

Type	Name	Description
DEVICE	Arterial Sealing

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2006-10-16
• Last updated: 2015-12-09

Locations

6 sites across 1 country: United States