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Completed

NCT Number: NCT00507013

Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose

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

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Key information

Conditions

Hemostasis,Surgical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Chaim Sheba M.C.

Tel Litwinsky, 52621, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Procedural Inclusion:

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

Exclusion criteria

  • Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks
  • Any closure device has been used on the ipsilateral arterial site within the previous 180 days
  • Any reentry of the ipsilateral site is planned within the next 6 weeks.
  • History of surgical repair of blood vessels of the ipsilateral arterial site
  • Significant bleeding diathesis or platelet dysfunction
  • Thrombocytopenia (Plt count ≤ 100,000)
  • Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
  • Has life expectancy of less than 1 year due to terminal illness
  • Currently being treated for an infection
  • Receiving GP 2b/3a inhibitors or requires warfarin therapy within the last 14 days.
  • INR results > 1.2 on day of procedure
  • Experienced a Myocardial infarction (CK-MB ≥ 2x upper limits of normal) within the previous 72 hours
  • Received thrombolytic within previous 72 hours
  • Patient is currently enrolled in an investigational device or drug study which endpoints have not been met.
  • Absent of pedal pulse
  • Pre-existing autoimmune disease (i.e., Lupus, Addison's Disease, Grave's Disease)
  • Has Body Mass Index(BMI) <20, or BMI >40

Treatment and study plan

QuickClose device

Device

Primary outcomes

  1. rate of complication

    Time frame: 30 days

Secondary outcomes

  1. time to hemostasis

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

CardioDex

Industry

Collaborators

  • Sheba Medical Center

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2007
First posted
Jul 25, 2007
Registry last updated
Apr 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.