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

Coronary Stenosis Clinical Trial

— EXPEL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01899235
• Other study ID #: N-20110015
• Status: Terminated
• Phase: Phase 4
• First received: July 11, 2013
• Last updated: March 15, 2014
• Start date: May 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Stenosis
• Stable Angina

Intervention

Device:
• drug eluting balloon

• drug eluting stent

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg Universitetshospital	Aachen Resonance GmbH

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events		3 months