CClinicalTrials.gg
TerminatedNCT01899235EXPELUpdated Mar 18, 2014

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

A Phase 4 interventional study of drug eluting balloon and drug eluting stent in Stable Angina and Coronary Stenosis, sponsored by Aalborg University Hospital. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-18.

Sponsored by Aalborg University Hospital · Phase 4, Interventional, and Treatment

Why this study was terminated
Slow recruitment
Phase
Phase 4
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Stable Angina
  • Coronary Stenosis
03

In context

Angina, Stable

345 studies on the registry are indexed under Angina, Stable; 57 are open to participants now.

Browse Angina, Stable studies →

Lead sponsor

Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment

Study arms

  • Active comparator
    Stent

    drug eluting stent (Resolute)

    Device: drug eluting stent

  • Experimental
    drug eluting balloon

    drug eluting balloon (Elutax)

    Device: drug eluting balloon

Interventions

  • Devicedrug eluting balloon
  • Devicedrug eluting stent
06

What researchers measure

Primary outcomes

  1. Major adverse cardiac events

    Time frame: 3 months

07

Study locations

1 site
  • Aalborg University Hospital
    Aalborg, 9000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01899235
Lead sponsor
Aalborg University Hospital
Collaborators
Aachen Resonance GmbH
Responsible party
Svend Eggert Jensen (Associate professor, MD, PhD, Aalborg University Hospital) — Principal investigator
First posted
Jul 15, 2013
Start date
May 2011
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Mar 18, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion