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CoagulationPhase 1/2NCT01121510

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

A Phase 1/2 study testing closure device in people with Coagulation and Therapeutic Uses, run by CardioDex at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
closure device
Type of treatment
Medical device
How many people
50 participants
Where
1 siteIsrael
Study dates
May 2010to May 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 50Show fewer
  • Significant bleeding diathesis or platelet dysfunction
  • Thrombocytopenia (Plt count ≤ 100,000)
  • Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
  • Hemophilia
  • Von Willebrand"s disease
  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Heart Institute Sheba medical center

    Tel HaShomer

Other trials in Israel

About this study

Official title: 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.

Read the 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

Being tested
closure device
Keywords
vascular closure device
Medical subject headings
Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • closure deviceDevice

    Also called wound healing

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of complications

    Establishing a rate of major complications

    Measured: 30 days

Secondary outcomes (1)

  1. time to hemostasis

    establishing a rate of time to hemostasis

    Measured: procedure day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJul 2010 (estimated)
  4. Study completionMay 2011 (estimated)

Why it stopped: medical center difficulties in recruiting patients for the study in a timely fashion

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01121510
Sponsor's protocol ID
RD 655-03
Status last verified
Sep 2010
First submitted
10 May 2010
Last updated
29 Sep 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing closure device in people with Coagulation and Therapeutic Uses, run by CardioDex at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of complications (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01121510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2010.

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