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PEPCAD I. The Paclitaxel-Eluting PTCA-Balloon Catheter to Treat Small Vessel

NCT00404144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-03-19

No results posted yet for this study

Summary

The objective of this study is to assess the safety and efficacy of the Paclitaxel-eluting PTCA-balloon catheter (3µg/mm2 balloon surface area) in the treatment of significant (≥ 70% and \< 100 %) stenoses in native coronary arteries with reference diameters from 2.25 mm to 2.8 mm and ≤ 22 mm in length for procedural success and preservation of vessel patency.

Conditions

  • Coronary Stenosis

Interventions

DEVICE

Drug Eluting Balloon

PCI of small vessels single arm study

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Clinical Research Institute, Center for Cardiovascular Disease Rotenburg a.d.F.

    collaborator UNKNOWN

  • Heart Centre Rotenburg

    lead OTHER

Principal Investigators

  • M. Unverdorben, MD,PhD · Center for Cardiovascular Diseases, Heinz-Meise-Strasse 100, D-36199 Rotenburg a.d. Fulda, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-08-31
Completion
2012-09-30

Countries

  • Germany

Study Locations

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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 NCT00404144 on ClinicalTrials.gov