NCT04796038

Rise Semi Compliant Balloon Study in Patient With CAD

Evaluation of the Acute Safety and Device Success of the RISE SC Coronary Balloon Dilatation Catheter When Used as a Dilatation Device in the Stenotic Portion of a Coronary Artery or Bypass Graft in Patients With Coronary Artery Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for data collection. Patients will be enrolled in up to 5 investigational sites in Switzerland. The patients will be followed up until discharge or until 7 days, whichever comes first.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Balloon dilatation	Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.

Timeline

• Start date: 2022-01-31
• Primary completion: 2022-11-09
• Completion: 2022-11-09
• First posted: 2021-03-12
• Last updated: 2023-01-25

Locations

3 sites across 1 country: Switzerland