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

NCT05637970 | Completed Results DMC FDA Device

• 1 other identifier: 22-000961
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Occlusion; Cardiovascular Diseases; Hematoma

Outcome Measures

Primary Outcomes (1)

• Time to Hemostasis

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

  24 hours post procedure (± 1 hour)

Secondary Outcomes (1)

• Patients With Hematoma

  24 hours post procedure (± 1 hour)

Study Arms (2)

Perclose Only

ACTIVE COMPARATOR

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.

Device: Perclose

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 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.

Device: Perclose; Device: Statseal

Interventions

Perclose DEVICE

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.

Also known as: Suture based hemostasis device

Perclose Only; Perclose with Statseal Device

Statseal DEVICE

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.

Also known as: potassium ferrate disc with topical hydrophilic polymer

Perclose with Statseal Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Delivery of a 14-16 French Transcatheter aortic valve replacement system

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California Ronald Reagan Medical Center

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Cardiovascular Diseases; Hematoma

Condition Hierarchy (Ancestors)

Vascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Tehrani
• Organization: UCLA

davidmtehrani@gmail.com

8583360666

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 6, 2022
• Study Start: January 12, 2023
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)