NCT01121510

Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System

The QuickClose Design 9 System Study

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: CardioDex · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and efficacy of the QuickClose design 9 closure device. patient undergoing a diagnostic or therapeutic angiogram procedure will be treated with the QuickClose Design 9. 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 endpoints is the incidence of minor complications related to method for achieving hemostasis at the puncture site. the primary efficacy endpoints are time to hemostasis, time to ambulation and time to discharge. the secondary efficacy endpoints are device and procedure success

Conditions

• Coagulation
• Therapeutic Uses
• Pharmacologic Actions

Interventions

Type	Name	Description
DEVICE	closure device	the invasive specialist must carefully manage the difficult balance of patient anticoagulation and coagulation for stopping the bleeding at the femoral artery puncture site. the QuickClose design 9 system is designed to benefit the patients and the medical staff by improving the process. the risks to patients associated with this study are considered reasonable in comparison to the anticipated benefits to the subjects, and the scientific knowledge that can be gained from the study.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-07-01
• Completion: 2011-05-01
• First posted: 2010-05-12
• Last updated: 2010-09-29

Locations

1 site across 1 country: Israel