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Clinical Trials/NCT01180517
NCT01180517
Completed
Phase 4

The Paclitaxel-Eluting PTCA-Balloon Catheter for the Treatment of Coronary Bifurcations

Ralf Degenhardt, PhD2 sites in 1 country64 target enrollmentNovember 2010
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ConditionsAngioplasty

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Angioplasty
Sponsor
Ralf Degenhardt, PhD
Enrollment
64
Locations
2
Primary Endpoint
In-segment late lumen loss in the side branch at 9 months
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
February 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ralf Degenhardt, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Ralf Degenhardt, PhD

Data Manager

Heart Centre Rotenburg

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 9 months

Study Sites (2)

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