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

A

Aalborg University Hospital

Status and phase

Terminated
Phase 4

Conditions

Stable Angina
Coronary Stenosis

Treatments

Device: drug eluting stent
Device: drug eluting balloon

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01899235
N-20110015

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Stent
Active Comparator group
Description:
drug eluting stent (Resolute)
Treatment:
Device: drug eluting stent
drug eluting balloon
Experimental group
Description:
drug eluting balloon (Elutax)
Treatment:
Device: drug eluting balloon

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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