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PAclitaxel-eluting Balloon in Primary PCI in Amsterdam; Pilot Study

NCT01274728 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2011-01-11

No results posted yet for this study

Summary

This clinical evaluation will study the feasibility and safety of a CE-marked paclitaxel-eluting balloon in primary PCI in patients with a STEMI. Drug eluting balloons provide the potential advantage of delivering a anti-proliferative drug, without the disadvantage of leaving a coronary stent, in STEMI patients treated with primary PCI.

Conditions

  • Acute Myocardial Infarction

Interventions

PROCEDURE

Percutaneous coronary intervention

Percutaneous coronary intervention with at least use of drug-eluting balloon and if necessary cross-over to bail-out stenting with BMS.

Sponsors & Collaborators

  • Onze Lieve Vrouwe Gasthuis

    lead OTHER

Principal Investigators

  • R.J. van der Schaaf, MD, PhD · Onze Lieve Vrouwe Gasthuis Amsterdam

  • M.T. Dirksen, MD, PhD · Onze Lieve Vrouwe Gasthuis Amsterdam

  • N.S. Vos, MD · Onze Lieve Vrouwe Gasthuis Amsterdam

  • J.P.H. Herrman, MD, PhD · Onze Lieve Vrouwe Gasthuis

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30

Countries

  • Netherlands

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 NCT01274728 on ClinicalTrials.gov