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

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