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Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure

Primary Purpose

Arterial Occlusion, Cardiovascular Diseases, Hematoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perclose
Statseal
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California Ronald Reagan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Perclose Only

Perclose with Statseal Device

Arm Description

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.

Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and 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.

Outcomes

Primary Outcome Measures

Time to hemostasis
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.

Secondary Outcome Measures

Percent of patients with hematoma
Presence of small <5cm, medium 5-10cm, or large >10cm hematoma based on physical exam or diagnostic imaging.

Full Information

First Posted
November 23, 2022
Last Updated
July 28, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05637970
Brief Title
Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure
Official Title
A Prospective Randomized Study Comparing the Time to Ambulation and Safety of Using a Closure Device Alone and in Conjunction With a Potassium Ferrate Pad (Statseal) Following Transcatheter Aortic Valve Replacement Via the Femoral Artery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusion, Cardiovascular Diseases, Hematoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perclose Only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Perclose with Statseal Device
Arm Type
Experimental
Arm Description
Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and 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.
Intervention Type
Device
Intervention Name(s)
Perclose
Other Intervention Name(s)
Suture based hemostasis device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Statseal
Other Intervention Name(s)
potassium ferrate disc with topical hydrophilic polymer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to hemostasis
Description
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
Time Frame
24 hours post procedure (± 1 hour)
Secondary Outcome Measure Information:
Title
Percent of patients with hematoma
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of California Ronald Reagan Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure

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