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

Primary Purpose

Stable Angina, Coronary Stenosis

Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
drug eluting balloon
drug eluting stent
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stent

drug eluting balloon

Arm Description

drug eluting stent (Resolute)

drug eluting balloon (Elutax)

Outcomes

Primary Outcome Measures

Major adverse cardiac events

Secondary Outcome Measures

Full Information

First Posted
July 11, 2013
Last Updated
March 15, 2014
Sponsor
Aalborg University Hospital
Collaborators
Aachen Resonance GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01899235
Brief Title
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
Acronym
EXPEL
Official Title
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Aachen Resonance GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Coronary Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
Stent
Arm Type
Active Comparator
Arm Description
drug eluting stent (Resolute)
Arm Title
drug eluting balloon
Arm Type
Experimental
Arm Description
drug eluting balloon (Elutax)
Intervention Type
Device
Intervention Name(s)
drug eluting balloon
Intervention Type
Device
Intervention Name(s)
drug eluting stent
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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