Hemostasis,Surgical Clinical Trial
Official title:
The QuickClose Study: Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose: a Prospective, Non-Randomized Clinical Study
| Verified date | April 2008 |
| Source | CardioDex |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | September 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. The patient must be = 18 years of age 2. The patient or guardian must provide written informed consent 3. The patient must be willing to comply with follow-up requirements 4. The patient has no child bearing potential or has a negative pregnancy test within the previous 7 days. 5. Patient is eligible for same day discharge Procedural Inclusion: 1. A intravascular procedure was preformed using 6 Fr introducer 2. The introducer sheath is located in the common femoral artery Exclusion Criteria: 1. Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks 2. Any closure device has been used on the ipsilateral arterial site within the previous 180 days 3. Any reentry of the ipsilateral site is planned within the next 6 weeks. 4. History of surgical repair of blood vessels of the ipsilateral arterial site 5. Significant bleeding diathesis or platelet dysfunction 1. Thrombocytopenia (Plt count = 100,000) 2. Anemia (Hgb = 10mg/dl and/or Hct = 30mg/dl) 6. Has life expectancy of less than 1 year due to terminal illness 7. Currently being treated for an infection 8. Receiving GP 2b/3a inhibitors or requires warfarin therapy within the last 14 days. 9. INR results > 1.2 on day of procedure 10. Experienced a Myocardial infarction (CK-MB = 2x upper limits of normal) within the previous 72 hours 11. Received thrombolytic within previous 72 hours 12. Patient is currently enrolled in an investigational device or drug study which endpoints have not been met. 13. Absent of pedal pulse 14. Pre-existing autoimmune disease (i.e., Lupus, Addison's Disease, Grave's Disease) 15. Has Body Mass Index(BMI) <20, or BMI >40 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Israel | The Chaim Sheba M.C. | Tel hashomer |
| Lead Sponsor | Collaborator |
|---|---|
| CardioDex | Sheba Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | rate of complication | 30 days | ||
| Secondary | time to hemostasis | 30 days |