Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose

April 22, 2008 updated by: CardioDex

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel hashomer, Israel, 52621
        • The Chaim Sheba M.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patient must be ≥ 18 years of age
  2. The patient or guardian must provide written informed consent
  3. The patient must be willing to comply with follow-up requirements
  4. The patient has no child bearing potential or has a negative pregnancy test within the previous 7 days.
  5. Patient is eligible for same day discharge

Procedural Inclusion:

  1. A intravascular procedure was preformed using 6 Fr introducer
  2. The introducer sheath is located in the common femoral artery

Exclusion Criteria:

  1. Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks
  2. Any closure device has been used on the ipsilateral arterial site within the previous 180 days
  3. Any reentry of the ipsilateral site is planned within the next 6 weeks.
  4. History of surgical repair of blood vessels of the ipsilateral arterial site

  5. Significant bleeding diathesis or platelet dysfunction

    1. Thrombocytopenia (Plt count ≤ 100,000)
    2. Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
  6. Has life expectancy of less than 1 year due to terminal illness
  7. Currently being treated for an infection
  8. Receiving GP 2b/3a inhibitors or requires warfarin therapy within the last 14 days.
  9. INR results > 1.2 on day of procedure
  10. Experienced a Myocardial infarction (CK-MB ≥ 2x upper limits of normal) within the previous 72 hours
  11. Received thrombolytic within previous 72 hours
  12. Patient is currently enrolled in an investigational device or drug study which endpoints have not been met.
  13. Absent of pedal pulse
  14. Pre-existing autoimmune disease (i.e., Lupus, Addison's Disease, Grave's Disease)
  15. Has Body Mass Index(BMI) <20, or BMI >40

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 2
Device: QuickClose device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of complication
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
time to hemostasis
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioDex

Collaborators

Sheba Medical Center

Investigators

  • Principal Investigator: Amit Segev, MD, The Chaim Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

July 23, 2007

First Submitted That Met QC Criteria

July 23, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

April 24, 2008

Last Update Submitted That Met QC Criteria

April 22, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RD 392-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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