NCT00507013

Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose

The QuickClose Study: Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose: a Prospective, Non-Randomized Clinical Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: CardioDex · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The QuickClose study is a prospective, non-randomized study, to evaluate the safety and efficacy of the QuickClose device using two different dose types of heat exposure. Patients undergoing a diagnostic angiogram procedure will be treated with the QuickClose device. Two groups of 20 patients each, will be enrolled consecutively, Group A will complete enrollment before enrollment into Group B begins. Patients will be monitored until 30 days after the procedure

Detailed description

The primary safety endpoint is the incidence of major complications related to method for achieving hemostasis at the puncture site. The secondary safety endpoint is the incidence of minor complications related to method for achieving hemostasis at the puncture site. The primary efficacy endpoint are time to hemostasis, time to ambulation and time to discharge . The secondary efficacy endpoints are device and procedure success.

Conditions

• Hemostasis,Surgical

Interventions

Type	Name	Description
DEVICE	QuickClose device

Timeline

• Start date: 2007-07-01
• Completion: 2007-09-01
• First posted: 2007-07-25
• Last updated: 2008-04-24

Locations

1 site across 1 country: Israel