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

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Jul 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well two devices, Perclose and Statseal, work together to help seal a blood vessel after a procedure that uses a thin tube (called a catheter) inserted through the leg. Both devices are already approved for this use and the hope is that using them together will help patients recover faster by reducing the time they need to lie flat after the procedure.

To be eligible for this study, participants should be adults aged 65 to 74 who are undergoing specific heart tests or treatments using a 6 French catheter through the femoral artery in the leg. However, those who have certain medical conditions, such as using other blood-clotting medications or having specific leg issues, won’t be able to join. If you participate, you can expect close monitoring and support throughout the process, and your healthcare team will guide you every step of the way. This study aims to improve recovery times for patients, making it an important step in heart care.

Gender

ALL

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.