Comparing two devices for closing arteries after heart procedures
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
This study is testing whether using two different devices together can help patients who have heart procedures stop bleeding faster so they can get back to normal activities sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT05468957 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to compare the effectiveness of two devices, Perclose and Statseal, in achieving hemostasis for patients undergoing transfemoral procedures with a 6 French access. Both devices are FDA-approved and have been previously used in clinical settings. The study hypothesizes that using both devices together will reduce the time required to seal the artery, allowing patients to resume normal positioning more quickly. Eligible patients include those undergoing diagnostic angiography or PCI with femoral access.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing diagnostic angiography or PCI with femoral access using a 6Fr system.
Not a fit: Patients who are exclusively using radial or other non-femoral access methods will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to quicker recovery times for patients after heart procedures.
How similar studies have performed: Other studies have shown success with similar hemostasis devices, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California and 1 other locations
- UCLA Ronald Reagen — Los Angeles, California, United States (Recruiting)
- UCLA Santa Monica — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: David M Tehrani, MD MS
- Email: dtehrani@mednet.ucla.edu
- Phone: 310-206-6286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.