Arterial Occlusion, Cardiovascular Diseases, Hematoma
Conditions
Brief summary
The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. 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 manual pressure will be held, shorter procedure time and less complications after the procedure.
Interventions
DEVICEPerclose
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five 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. 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. This will be continued until the patient has no bleeding.
DEVICEStatseal
Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manualpressure will be held for at least five 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. 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. This will be continued until the patient has no bleeding.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Delivery of a 14-16 French Transcatheter aortic valve replacement system
Exclusion criteria
* Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc). * Use of an anticoagulant other than unfractionated heparin or bivalirudin during the procedure. * Any use of glycoprotein inhibitors or cangrelor. * Use of sheathless guides. * Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion. * Any active treatment with oral anticoagulants continued during course of procedure. * Presence of arteriovenous dialysis fistula in the ipsilateral leg. * Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band. * Inability of the patient to personally consent for the study. (no surrogate consent) * Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | 24 hours post procedure (± 1 hour) | From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Hematoma | 24 hours post procedure (± 1 hour) | Presence of small \<5cm, medium 5-10cm, or large \>10cm hematoma based on physical exam or diagnostic imaging. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perclose Only Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five 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. 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. This will be continued until the patient has no bleeding.
Perclose: Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five 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. | 26 |
| Perclose With Statseal Device Statseal: Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manualpressure will be held for at least five 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. 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. This will be continued until the patient has no bleeding. | 24 |
| Total | 50 |
Baseline characteristics
| Characteristic | Perclose With Statseal Device | Total | Perclose Only |
|---|---|---|---|
| Age, Continuous | 80.0 years STANDARD_DEVIATION 7.3 | 79.6 years STANDARD_DEVIATION 7.1 | 79.2 years STANDARD_DEVIATION 6.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 24 participants | 50 participants | 26 participants |
| Sex: Female, Male Female | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Male | 16 Participants | 33 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
Time to Hemostasis
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
Time frame: 24 hours post procedure (± 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perclose Only | Time to Hemostasis | 5.11 minutes | Standard Deviation 4.4 |
| Perclose With Statseal Device | Time to Hemostasis | 4.3 minutes | Standard Deviation 4.4 |
Secondary
Patients With Hematoma
Presence of small \<5cm, medium 5-10cm, or large \>10cm hematoma based on physical exam or diagnostic imaging.
Time frame: 24 hours post procedure (± 1 hour)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Perclose Only | Patients With Hematoma | Small <5cm | 0 Participants |
| Perclose Only | Patients With Hematoma | Medium 5-10cm | 0 Participants |
| Perclose Only | Patients With Hematoma | Large >10cm | 1 Participants |
| Perclose With Statseal Device | Patients With Hematoma | Small <5cm | 0 Participants |
| Perclose With Statseal Device | Patients With Hematoma | Medium 5-10cm | 0 Participants |
| Perclose With Statseal Device | Patients With Hematoma | Large >10cm | 1 Participants |