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

September 28, 2010 updated by: CardioDex

The QuickClose Design 9 System Study

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.

Study Overview

Status

Withdrawn

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 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

Study Type

Interventional

Enrollment (Anticipated)

50

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

      • Tel Hashomer, Israel
        • Heart Institute Sheba medical center

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of complications
Time Frame: 30 days
Establishing a rate of major complications
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to hemostasis
Time Frame: procedure day
establishing a rate of time to hemostasis
procedure day

Collaborators and Investigators

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

Sponsor

Collaborators

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

May 1, 2010

Primary Completion (ANTICIPATED)

July 1, 2010

Study Completion (ANTICIPATED)

May 1, 2011

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (ESTIMATE)

May 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2010

Last Update Submitted That Met QC Criteria

September 28, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • RD 655-03

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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