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

Phase 4

Terminated

• Conditions: Stable Angina; Coronary Stenosis
• Interventions: Device: drug eluting stent; Device: drug eluting balloon

• Registration Number: NCT01899235
• Lead Sponsor: Aalborg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-15
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stent	drug eluting stent	drug eluting stent (Resolute)
drug eluting balloon	drug eluting balloon	drug eluting balloon (Elutax)

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	3 months

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark