NCT03923387

Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device

A Multicenter, Open Label, Prospective, Randomized Study of the MynxGrip Vascular Closure Device in Subjects With Diagnostic or Interventional Endovascular Procedures (PANDA Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery puncture site, compared with manual compression hemostasis in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.

Detailed description

Effectiveness: to superiority to the control group in time to hemostasis. Comparison of time to ambulation, procedure success rate, length of stay in hospital, device success rate. Safety-Major/Minor complication rate, adverse events, SAEs as compared to control.

Conditions

• Endovascular

Interventions

Type	Name	Description
DEVICE	MynxGrip	Vascular Closure
OTHER	Manual compression	Manual compression is a commonly used method to achieve hemostasis of femoral artery

Timeline

• Start date: 2019-05-07
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2019-04-22
• Last updated: 2022-06-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study