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

NCT01121510 | Withdrawn Phase 1 DMC

• 1 other identifier: RD 655-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coagulation; Therapeutic Uses; Pharmacologic Actions

Keywords

vascular closure device

Outcome Measures

Primary Outcomes (1)

• rate of complications

  Establishing a rate of major complications

  30 days

Secondary Outcomes (1)

• time to hemostasis

  procedure day

Interventions

closure device 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.

Also known as: wound healing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• CardioDex: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Heart Institute Sheba medical center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Vascular Closure Devices

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

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

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: May 1, 2011
• Last Updated: September 29, 2010

Record last verified: 2010-09

Locations

IL (1)