Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose (NCT00507013) | Clinical Trial Compass
CompletedPhase 1/2
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose
Israel8 participantsStarted 2007-07
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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