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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01899235

Acronym

EXPEL

Enrollment

Unknown

Registered

2013-07-15

Start date

2011-05-31

Completion date

2014-03-31

Last updated

2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Angina, Coronary Stenosis

Brief 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.

Interventions

DEVICEdrug eluting balloon

DEVICEdrug eluting stent

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Major adverse cardiac events	3 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026