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
About this trial
This is an interventional treatment trial for Stable Angina
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
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
NCT ID
NCT01899235
First Posted
July 11, 2013
Last Updated
March 15, 2014
Sponsor
Aalborg University Hospital
Collaborators
Aachen Resonance GmbH
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
We'll reach out to this number within 24 hrs