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Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose

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ClinicalTrials.gov Identifier: NCT00507013
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : April 24, 2008
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by:
CardioDex

July 23, 2007
July 25, 2007
April 24, 2008
July 2007
Not Provided
rate of complication [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT00507013 on ClinicalTrials.gov Archive Site
time to hemostasis [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
 
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose
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

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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Hemostasis,Surgical
Device: QuickClose device
2
Intervention: Device: QuickClose device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
Same as current
September 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00507013
RD 392-03
No
Not Provided
Not Provided
Not Provided
CardioDex
Sheba Medical Center
Principal Investigator: Amit Segev, MD The Chaim Sheba Medical Center
CardioDex
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP