A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access.

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · May 11, 2023

Keywords

ClinConnect Summary

**Study Summary:**

This clinical trial is comparing two methods for closing a specific type of access point in the body after certain medical procedures involving the veins in the leg. The two techniques being studied are the Perclose Proglide system, which uses a special device to help seal the vein, and the figure-of-8 suture method, which uses stitches in a specific pattern to achieve the same goal. The main aim is to see which method is safer and more effective for patients who have undergone procedures that require a larger size access point in the vein.

To be eligible for this trial, participants need to be adults over 18 years old who have had a specific type of procedure that accessed the femoral vein (the large vein in the thigh) using tools that are at least 14 French in size (that’s a measurement for the width of the access). However, individuals who have had previous surgeries on their blood vessels or who needed a different type of access will not be able to participate. If you join the trial, you will receive one of the two closure methods, and researchers will monitor your recovery to gather information on which method works better. This study is currently looking for volunteers, and both men and women are welcome to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients will meet all inclusion criteria:
• • Adult patients aged \> 18 years
• • Patients who have undergone percutaneous interventional procedures
• • Patients in whom the procedures have been performed with femoral venous access
• • Patients who have required large caliber pods ≥ 14 French.
• Exclusion Criteria:
• Patients must not meet any exclusion criteria:
• • Patients who have required access with surgical exposure.
• • Patients who have required ipsilateral arterial access with a large caliber ≥ 14 French
• • Patients with previous vascular surgery.