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

NCT01121510 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-09-29

No results posted yet for this study

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.

Conditions

  • Coagulation
  • Therapeutic Uses
  • Pharmacologic Actions

Interventions

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.

Sponsors & Collaborators

  • Sheba Medical Center

    collaborator OTHER_GOV

  • CardioDex

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-07-31
Completion
2011-05-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01121510 on ClinicalTrials.gov