Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose

Study Overview
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Brief Summary
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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

Detailed Description
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The primary safety endpoint is the incidence of major complications related to method for achieving hemostasis at the puncture site. The secondary safety endpoint is the incidence of minor complications related to method for achieving hemostasis at the puncture site. The primary efficacy endpoint are time to hemostasis, time to ambulation and time to discharge . The secondary efficacy endpoints are device and procedure success.

Official Title
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The QuickClose Study: Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose: a Prospective, Non-Randomized Clinical Study

Conditions
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Hemostasis,Surgical

Intervention / Treatment
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* Device: QuickClose device


Participation Criteria
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Eligibility Criteria
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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 Procedural Inclusion: 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 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 Pre-existing autoimmune disease (i.e., Lupus, Addison's Disease, Grave's Disease) Has Body Mass Index(BMI) <20, or BMI >40

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2<br> | Device: QuickClose device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of complication |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to hemostasis |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular closure device