Comparing Perclose to Statseal in Conjunction with Perclose in Femoral 6 French Arteriotomy Closure

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 1, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

July 31, 2025

Conditions
Arterial OcclusionCardiovascular DiseasesAtherosclerosisHematoma
Interventions
DEVICE

Perclose

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.

DRUG

Statseal

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.

Trial Locations (2)

90025

RECRUITING

UCLA Ronald Reagen, Los Angeles

RECRUITING

UCLA Santa Monica, Los Angeles

All Listed Sponsors
lead

University of California, Los Angeles

OTHER