Back to resultsThe 001-DIOR Multicenter Registry
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
DIOR drug-eluting PTCA balloon
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- De novo bifurcated lesions 001 of Medina classification, with significant stenosis only in the ostium of the side branch and a reference vessel diameter is bigger or equal 2.0mm; the DIOR balloon will be used to the treat the side branch.
- The patient has clinical evidence of myocardial ischemia (stable or unstable angina, acute and non acute myocardial infarction, silent ischemia: ECG, exercise test, etz...)
- As the maximal length of the DIORTM balloon is 30 mm, all eligible lesions should be no longer than 25 mm to ensure an adequate drug elution in the treated segment, avoiding the phenomenon of "geographical miss" .
- Target lesion(s) stenosis is more or equal 50% by visual estimation.
Exclusion Criteria:
- Cardiogenic shock
- Any serious disease that might limit patient survival to less than one year
- Inability to perform clinical follow-up for a period of 1 year
- Left main bifurcation lesions: ostial left circumflex or ostial left anterior descending artery stenosis.
- Lesion length > 25 mm
- Target vessel reference diameter < 2mm
- Stenosis < 50% of the reference luminal diameter
- Severe angiographic calcification at the level of the target lesion
Sites / Locations
- Hospital del Mar
- Hospital Sant Pau
- Hospital Trías i Pujol
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Dior
Arm Description
One arm observational registry using the Dior paclitaxel eluting balloon for the treatment of de novo ostial bifurcated lesions.
Outcomes
Primary Outcome Measures
Major adverse cardiac events (MACE)
MACE rate defined as the rate of cardiac death and/or myocardial infarction (MI) and/or target lesion revascularization (TLR)
Secondary Outcome Measures
target vessel revascularization (TVR) rate, either symptom or ischemia-driven
Segment treated thrombosis (STT), according to ARC definitions
Late Lumen Loss
Late lumen loss determinated by control angiography
Binary restenosis rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01375465
Brief Title
The 001-DIOR Multicenter Registry
Official Title
The 001-DIOR Multicenter Registry (A Novel Percutaneous Coronary Intervention With the New Paclitaxel-eluting Balloon DIOR in Ostial Bifurcated Lesions)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurocor GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary intervention (PCI) to assess the clinical success, efficacy and safety of the Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat the stenotic site branch.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dior
Arm Type
Other
Arm Description
One arm observational registry using the Dior paclitaxel eluting balloon for the treatment of de novo ostial bifurcated lesions.
Intervention Type
Device
Intervention Name(s)
DIOR drug-eluting PTCA balloon
Intervention Description
Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)
Primary Outcome Measure Information:
Title
Major adverse cardiac events (MACE)
Description
MACE rate defined as the rate of cardiac death and/or myocardial infarction (MI) and/or target lesion revascularization (TLR)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
target vessel revascularization (TVR) rate, either symptom or ischemia-driven
Time Frame
6 months
Title
Segment treated thrombosis (STT), according to ARC definitions
Time Frame
6 months
Title
Late Lumen Loss
Description
Late lumen loss determinated by control angiography
Time Frame
6 months
Title
Binary restenosis rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
De novo bifurcated lesions 001 of Medina classification, with significant stenosis only in the ostium of the side branch and a reference vessel diameter is bigger or equal 2.0mm; the DIOR balloon will be used to the treat the side branch.
The patient has clinical evidence of myocardial ischemia (stable or unstable angina, acute and non acute myocardial infarction, silent ischemia: ECG, exercise test, etz...)
As the maximal length of the DIORTM balloon is 30 mm, all eligible lesions should be no longer than 25 mm to ensure an adequate drug elution in the treated segment, avoiding the phenomenon of "geographical miss" .
Target lesion(s) stenosis is more or equal 50% by visual estimation.
Exclusion Criteria:
Cardiogenic shock
Any serious disease that might limit patient survival to less than one year
Inability to perform clinical follow-up for a period of 1 year
Left main bifurcation lesions: ostial left circumflex or ostial left anterior descending artery stenosis.
Lesion length > 25 mm
Target vessel reference diameter < 2mm
Stenosis < 50% of the reference luminal diameter
Severe angiographic calcification at the level of the target lesion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Serra, MD, PhD
Organizational Affiliation
Hospital Sant Pau, Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beatriz Vaquerizo, MD, PhD
Organizational Affiliation
Hospital Sant Pau, Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Trías i Pujol
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
The 001-DIOR Multicenter Registry
We'll reach out to this number within 24 hrs