The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study (EXPEL)

March 15, 2014 updated by: Svend Eggert Jensen, Aalborg University Hospital
A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient ≥ 18years old
  • Stable angina symptoms
  • Elective treatment to coronary lesion
  • Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection

Exclusion Criteria:

  • Left main stem lesion
  • Bifurcation lesions
  • Acute coronary syndrome (UAP, NSTEMI, STEMI)
  • Cardiogenic shock
  • Chronic total occlusion
  • Additional lesions requiring PCI
  • Platelet count ≤ 50 x 109/mm3
  • Left ventricular ejection fraction ≤ 30%
  • Patient life expectancy less than 12 months
  • Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel
  • Participation in another investigational drug or device study
  • Patient unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Stent
drug eluting stent (Resolute)
Device: drug eluting stent
EXPERIMENTAL: drug eluting balloon
drug eluting balloon (Elutax)
Device: drug eluting balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac events
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Collaborators

Aachen Resonance GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (ESTIMATE)

July 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 15, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20110015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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