Clinical trials: Large Hole Percutaneous Arterial Closure
Percutaneous Common Femoral Artery Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device
The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral…
- Trial name
- FRONTIER-II (NCT02241642)
- Testing
- VIVASURE CLOSURE DEVICE™
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 65 people
- Sponsor
- Vivasure Medical Limited
Percutaneous Closure of Arteriotomy in Common Femoral Artery
Safety and Performance Study of Large Hole Vascular Closure Device
The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture…
- Trial name
- FRONTIER-I (NCT01943344)
- Testing
- VIVASURE CLOSURE DEVICE™
- Where
- Ireland
- Volunteers
- 12 people
- Sponsor
- Vivasure Medical Limited
Large Hole Percutaneous Arterial Closure
Safety and Performance Study of Large Hole Vascular Closure Device - France
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 20 patients in 2 centres within France.
- Trial name
- FRONTIER V (NCT05323877)
- Testing
- Test Device (PerQseal+)
- Volunteers
- 20 people
- Sponsor
- Vivasure Medical Limited
Percutaneous Large Hole Vascular Closure
PerQseal® Impella Early Feasibility Study
The purpose of this Clinical Investigation Plan is to assess the initial feasibility results of the PerQseal® device, when used on this very specific Impella population.
- Trial name
- NCT04818541
- Testing
- PPCI, Cardiogenic shock
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- Vivasure Medical Limited
Percutaneous Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites.
- Trial name
- NCT04799769
- Testing
- Percutaneous arterial closure device
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 90 people
- Sponsor
- Vivasure Medical Limited
Large Hole Percutaneous Arterial Closure
Safety and Performance Study for Arterial Large Hole Vascular Closure Device
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients…
- Trial name
- ELITE (NCT05951634)
- Testing
- PerQseal ELITE
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited