Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose

This study has been completed.
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by:
CardioDex
ClinicalTrials.gov Identifier:
NCT00507013
First received: July 23, 2007
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Hemostasis,Surgical
Device: QuickClose device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The QuickClose Study: Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose: a Prospective, Non-Randomized Clinical Study

Further study details as provided by CardioDex:

Primary Outcome Measures:
  • rate of complication [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • time to hemostasis [ Time Frame: 30 days ]

Enrollment: 8
Study Start Date: July 2007
Study Completion Date: September 2007
Arms Assigned Interventions
2 Device: QuickClose device

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507013

Locations
Israel
The Chaim Sheba M.C.
Tel hashomer, Israel, 52621
Sponsors and Collaborators
CardioDex
Sheba Medical Center
Investigators
Principal Investigator: Amit Segev, MD The Chaim Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00507013     History of Changes
Other Study ID Numbers: RD 392-03
Study First Received: July 23, 2007
Last Updated: April 22, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by CardioDex:
vascular closure device

Additional relevant MeSH terms:
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014