NCT05334095

Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease

Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease: a Prospective Single-center Randomized Non-inferiority Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,062 (estimated)
• Sponsor: Xiongjing Jiang · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy (device deployment characteristics and performance) and safety (adverse access site related events) of Perclose ProGlide (Abbott Vascular Devices) for femoral access site closure in patients undergoing peripheral vascular diagnostic and interventional procedures in comparison with Angio-seal VIP (St. Jude Medical).

Detailed description

Prospective, single-center, randomized (1:1), open-label, non-inferiority study in 1062 patients comparing Perclose ProGlide (test device) to the Angio-seal VIP (standard comparator).

Conditions

• Peripheral Vascular Diseases
• Percutaneous Intervention Via Femoral Artery

Interventions

Type	Name	Description
DEVICE	Perclose ProGlide	After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide.
DEVICE	Angio-seal VIP	After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP

Timeline

• Start date: 2019-08-20
• Primary completion: 2022-06-01
• Completion: 2022-09-01
• First posted: 2022-04-19
• Last updated: 2022-04-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study