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

NCT05468957 | Withdrawn DMC FDA Device

• 1 other identifier: 22-000700
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Arterial Occlusion; Cardiovascular Diseases; Atherosclerosis; Hematoma

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Time to Discharge

  At least 15 minutes after abultation occurs for those in the outpatient setting.

• Time to hemostasis

  Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first

• Percent of patients with hematoma

  Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first

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 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.

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 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.

Device: Perclose; Drug: Statseal

Interventions

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.

Also known as: Suture based hemostasis device

Perclose Only; Perclose with Statseal Device

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.

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:

• Patient undergoing diagnostic angiography or PCI with femoral access who undergo PercloseTM closure.
• Catheterization with a 6Fr system
• Those with a planned radial approach will also be enrolled given the possibility of changing to femoral access in the catheterization lab if radial access is not possible given radial artery spasm, significant patient discomfort with a contraindication to greater levels of sedation, inability to transverse guidewire into the aortic root, inability to engage coronary artery or deliver equipment, or other clinically indicated reason.

You may not qualify if:

• \- Candidates for this study will be excluded if any one of the following criteria is true:
• Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc).
• Patients undergoing catheterization only from the radial, brachial, ulnar, or distal radial (snuffbox) artery approach.
• Use of an anticoagulant other than unfractionated heparin or bivalirudin.
• 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 (2)

UCLA Ronald Reagen

Los Angeles, California, 90025, United States

Location

UCLA Santa Monica

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis; Hematoma

Condition Hierarchy (Ancestors)

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

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: July 18, 2022
• First Posted: July 21, 2022
• Study Start: August 1, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (2)