NCT03756558

Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System

Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Terumo Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.

Detailed description

The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8-18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.

Conditions

• Vascular Closure

Interventions

Type	Name	Description
DEVICE	Cross-Seal System	Use of the Cross-Seal system to close the femoral arteriotomy

Timeline

• Start date: 2019-08-09
• Primary completion: 2021-03-22
• Completion: 2021-03-22
• First posted: 2018-11-28
• Last updated: 2025-09-15
• Results posted: 2025-09-15

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study