Hemostasis,Surgical
Conditions
Keywords
vascular closure device
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
Detailed description
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.
Interventions
DEVICEQuickClose device
Sponsors
Sheba Medical Center
CardioDex
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of complication | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| time to hemostasis | 30 days |
Countries
Israel
Outcome results
None listed