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

This study has been withdrawn prior to enrollment.
(medical center difficulties in recruiting patients for the study in a timely fashion)
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by:
CardioDex
ClinicalTrials.gov Identifier:
NCT01121510
First received: May 10, 2010
Last updated: September 28, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Coagulation
Therapeutic Uses
Pharmacologic Actions
Device: closure device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The QuickClose Design 9 System Study

Further study details as provided by CardioDex:

Primary Outcome Measures:
  • rate of complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Establishing a rate of major complications


Secondary Outcome Measures:
  • time to hemostasis [ Time Frame: procedure day ] [ Designated as safety issue: No ]
    establishing a rate of time to hemostasis


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: wound healing
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 endpoints is the incidence of minor complications related to method for achieving hemostasis at the puncture site. the primary efficacy endpoints 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 to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patient/legal representative provides written informed consent
  • Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure
  • Target vessel has a lumen diameter ≥ 6 mm
  • Patient must be willing to comply with follow-up requirements
  • Patient has a 5-7F arterial puncture located in the common femoral artery

Exclusion Criteria:

  • Arterial puncture in the femoral artery of both legs
  • Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks
  • Any closure system 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
  • Patient is unable to ambulate at baseline
  • Significant bleeding diathesis or platelet dysfunction

    1. Thrombocytopenia (Plt count ≤ 100,000)
    2. Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
    3. Hemophilia
    4. Von Willebrand"s disease
    5. Thrombophilia (i.e. factor 5 deficiency or other)
  • ST-elevation myocardial infarction ≤ 48 hours prior to the cardiac or peripheral catheterization procedure
  • Pre-existing severe non-cardiac systemic disease or pre-existing terminal illness
  • Pre-existing systemic or cutaneous infection
  • Receiving warfarin therapy within the last 14 days.
  • INR results > 1.2 on day of procedure for any patient with a history of warfarin therapy
  • Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
  • Concurrent participation in another investigational device or drug trial
  • Angiomax (bivalirudin) or other thrombin-specific anticoagulants or low molecular weight heparin ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
  • Planned arterial access at the same access site ≤ 30 days following the femoral artery closure procedure
  • Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure
  • Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery
  • Symptomatic leg ischemia in the target vessel limb including severe claudication or weak/absent pulse
  • Absent of pedal pulse on ipsilateral side
  • Pre-existing autoimmune disease
  • BMI > 40 kg/m2
  • The targeted femoral artery is tortuous or requires an introducer sheath length > 11 cm
  • Fluoroscopically visible calcium, atherosclerotic disease, or stent ≤ 1 cm of the puncture site that would interfere with the placement of the VCD's plug
  • Suspected bacterial contamination of access site
  • Puncture through a vascular graft
  • Double wall puncture
  • Antegrade puncture
  • Palpable Hematoma
  • Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
  • Any Arterial and/or Venous access on the ipsilateral or contralateral groin other than target study access site
  • Patient is not cooperative
  • Intra-procedural therapeutic thrombolysis is preformed
  • Uncontrolled hypertension at time of sheath removal (blood pressure ≥ 170 mmHg systolic and/or ≥ 100mmHg diastolic)
  • Peripheral vascular disease on the ipsilateral arterial vessel (≥ 50% stenosis) or aneurismal disease of this vessel.
  • Sheaths has been changed during the procedure
  • Heparinized patients with elevated pre-closure ACT level≥ 300 seconds
  • Patient has known allergy to any materials used in the VCD
  • Patient is known to require an extended hospitalization (e.g. patient is undergoing CABG surgery)
  • Prior or recent use of an intra-aortic balloon pump through the arterial access site
  • Cardiogenic shock (hemodynamic instability requiring intravenous medications or mechanical support) experienced during or immediately post-catheterization
  • Patient is known or suspected to be pregnant, or is lactating
  • Patient has known allergy to contrast medium
  • Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the use of the VCD
  • Required simultaneous ipsilateral or contralateral venous puncture
  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: NCT01121510

Locations
Israel
Heart Institute Sheba medical center
Tel Hashomer, Israel
Sponsors and Collaborators
CardioDex
Sheba Medical Center
  More Information

No publications provided

Responsible Party: principal investigator: Dan Elian, MD, The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01121510     History of Changes
Other Study ID Numbers: RD 655-03
Study First Received: May 10, 2010
Last Updated: September 28, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by CardioDex:
vascular closure device

ClinicalTrials.gov processed this record on July 20, 2014