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| Name | Class |
|---|---|
| Sheba Medical Center | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuickClose device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of complication | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| time to hemostasis | 30 days |
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Inclusion Criteria:
Procedural Inclusion:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Amit Segev, MD | The Chaim Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chaim Sheba M.C. | Tel Litwinsky | 52621 | Israel |
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