Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose

NCT00507013 | Completed Phase 1

• 1 other identifier: RD 392-03
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemostasis,Surgical

Keywords

vascular closure device

Outcome Measures

Primary Outcomes (1)

• rate of complication

  30 days

Secondary Outcomes (1)

• time to hemostasis

  30 days

Study Arms (1)

2

OTHER

Device: QuickClose device

Interventions

QuickClose device DEVICE

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be ≥ 18 years of age
• The patient or guardian must provide written informed consent
• The patient must be willing to comply with follow-up requirements
• The patient has no child bearing potential or has a negative pregnancy test within the previous 7 days.
• Patient is eligible for same day discharge
• A intravascular procedure was preformed using 6 Fr introducer
• The introducer sheath is located in the common femoral artery

You may not qualify if:

• Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks
• Any closure device 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
• Significant bleeding diathesis or platelet dysfunction
• Thrombocytopenia (Plt count ≤ 100,000)
• Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
• Has life expectancy of less than 1 year due to terminal illness
• Currently being treated for an infection
• Receiving GP 2b/3a inhibitors or requires warfarin therapy within the last 14 days.
• INR results \> 1.2 on day of procedure
• Experienced a Myocardial infarction (CK-MB ≥ 2x upper limits of normal) within the previous 72 hours
• Received thrombolytic within previous 72 hours
• Patient is currently enrolled in an investigational device or drug study which endpoints have not been met.
• Absent of pedal pulse

Sponsors & Collaborators

• CardioDex: lead
• Sheba Medical Center: collaborator

Study Sites (1)

The Chaim Sheba M.C.

Tel Litwinsky, 52621, Israel

Location

Study Officials

• Amit Segev, MD

  The Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: July 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 24, 2008

Record last verified: 2008-04

Locations

IL (1)