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Initiating PI left our institution.
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The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 French Access. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that patients would need to lay flat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perclose Only | Active Comparator | Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation. |
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| Perclose with Statseal Device | Experimental | Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perclose | Device | Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Ambulation | From the time of manual compression after PercloseTM deployed until ambulation is initated after hemostasis is achieved. | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge | From the time of manual compression after PercloseTM deployed until discharge order is activated. | At least 15 minutes after abultation occurs for those in the outpatient setting. |
| Time to hemostasis |
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Inclusion Criteria:
Exclusion Criteria:
- Candidates for this study will be excluded if any one of the following criteria is true:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Ronald Reagen | Los Angeles | California | 90025 | United States | ||
| UCLA Santa Monica |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| Statseal | Drug | Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation. |
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From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
| Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first |
| Percent of patients with hematoma | Presence of small <5cm, medium 5-10cm, or large >10cm hematoma based on physical exam or diagnostic imaging. | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first |
| Los Angeles |
| California |
| 90025 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |