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

2014-08-27 03:13:46 | BioPortfolio

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.

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

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Coagulation

Intervention

closure device

Location

Heart Institute Sheba medical center
Tel Hashomer
Israel

Status

Recruiting

Source

CardioDex

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:46-0400

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