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

• 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

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	3 months

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark