The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations

Phase 4

Completed

• Conditions: Angioplasty
• Interventions: Procedure: PCI; Procedure: Percutaneous coronary intervention (PCI)

• Registration Number: NCT01180517
• Lead Sponsor: Ralf Degenhardt, PhD

Brief Summary

The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention (PCI) of Medina 0,0,1 coronary bifurcation lesions. Patients will be randomized to treatment with Plain Old Balloon Angioplasty (POBA)or treatment with DEB.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Study Start: 2010-11
• Primary Completion: 2014-11
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plain Old Balloon Angioplasty (POBA)	PCI	-
Drug Eluting Balloon	Percutaneous coronary intervention (PCI)	-

Primary Outcome Measures

Name	Time	Method
In-segment late lumen loss in the side branch at 9 months	9 months

Trial Locations

Locations (2)

Klinikum Ernst von Bergmann; 🇩🇪 Potsdam, Germany

Herzzentrum Dresden; 🇩🇪 Dresden, Germany