Clinical trial NCT05468957: Comparing Perclose to Statseal in Conjunction with Perclose in Femoral 6 French Arteriotomy Closure
Official title: A Prospective Randomized Study Comparing Time to Ambulation, Time to Hemostasis and Safety Using a Closure Device Alone an in Conjunction with a Potassium Ferrate Pad Following Transfemoral Catheterization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arterial Occlusion
Cardiovascular Diseases
Atherosclerosis
Hematoma
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- 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.

Primary outcomes:
measure: Time to Ambulation
timeFrame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
Secondary outcomes:
measure: Time to Discharge
timeFrame: At least 15 minutes after abultation occurs for those in the outpatient setting.
measure: Time to hemostasis
timeFrame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first
measure: Percent of patients with hematoma
timeFrame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Ronald Reagen
state: California
city: Los Angeles
country: United States
facility: UCLA Santa Monica
state: California
Study officials:
References: