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The 001-DIOR Multicenter Registry

NCT01375465 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-09-23

No results posted yet for this study

Summary

The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary intervention (PCI) to assess the clinical success, efficacy and safety of the Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat the stenotic site branch.

Conditions

Interventions

DEVICE

DIOR drug-eluting PTCA balloon

Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)

Sponsors & Collaborators

  • Eurocor GmbH

    lead INDUSTRY

Principal Investigators

  • Antonio Serra, MD, PhD · Hospital Sant Pau, Barcelona

  • Beatriz Vaquerizo, MD, PhD · Hospital Sant Pau, Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375465 on ClinicalTrials.gov