NCT01574534

Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions

A Prospective, Randomized, Controlled, Open Label, Multicenter Trial to Test the Non-inferiority of Drug Eluting Balloon vs. Drug Eluting Stent Treatment in de Novo Stenoses of Small Native Vessels Regarding Efficacy and Safety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 758 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that in a real-world population undergoing percutaneous coronary intervention (PCI) for de-novo stenoses in small native vessels with a diameter \<3 mm, drug eluting balloons (DEB) are non inferior to third-generation drug eluting stents (DES).

Detailed description

Drug-eluting balloons are an established treatment for in-stent stenoses and showed good results in small vessels. Moreover, the available data suggest that DEB are a promising new technique for the treatment of de-novo stenoses in small vessels if pre-dilatation is performed and geographical mismatch is avoided. The aim of this study is to demonstrate that DEB is non-inferior to DES in a real-world population with respect to the combined clinical endpoint Major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	Drug eluting balloon	PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany
DEVICE	Drug eluting stent	PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA

Timeline

• Start date: 2012-04-01
• Primary completion: 2018-02-01
• Completion: 2020-01-15
• First posted: 2012-04-10
• Last updated: 2020-06-24

Locations

14 sites across 3 countries: Austria, Germany, Switzerland