NCT01180517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

4 years

First QC Date

August 9, 2010

Last Update Submit

February 18, 2016

Conditions

Angioplasty

Keywords

Angioplasty Balloon

Outcome Measures

Primary Outcomes (1)

  • In-segment late lumen loss in the side branch at 9 months

    9 months

Study Arms (2)

Drug Eluting Balloon

ACTIVE COMPARATOR
Procedure: Percutaneous coronary intervention (PCI)

Plain Old Balloon Angioplasty (POBA)

ACTIVE COMPARATOR
Procedure: PCI

Interventions

Percutaneous coronary intervention (PCI)PROCEDURE

balloon angioplasty

Drug Eluting Balloon
PCIPROCEDURE

balloon angioplasty

Plain Old Balloon Angioplasty (POBA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • De-novo Medina type 0,0,1 bifurcational native coronary artery lesion (reference diameter:\>2.0 mm \<3.5 mm, length of stenosis: ≤ 10 mm), the diameter of the side branch shall be smaller or equal to the diameter of the distal end vessel

You may not qualify if:

  • Reference side branch diameter \> 3.5 mm
  • Evidence of extensive thrombosis within target vessel
  • Patients with another coronary stent implanted previously into the target branch or bifurcation ≤ 15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEPCAD- BIF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herzzentrum Dresden

Dresden, 01307, Germany

Location

Klinikum Ernst von Bergmann

Potsdam, 14467, Germany

Location

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • F. X. Kleber, MD

    Klinikum Ernst von Bergmann Potsdam, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Data Manager

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 12, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2014

Study Completion

February 1, 2016

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

DE(2)