Coronary Artery DiseasePhase 4NCT01375465
The 001-DIOR Multicenter Registry
A Phase 4 study testing DIOR drug-eluting PTCA balloon in people with Coronary Artery Disease, run by Eurocor GmbH at 3 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- DIOR drug-eluting PTCA balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSpain
- Study dates
- Feb 2011to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital del Mar
Barcelona
Hospital Sant Pau
Barcelona
Hospital Trías i Pujol
Barcelona
About this study
Official title: The 001-DIOR Multicenter Registry (A Novel Percutaneous Coronary Intervention With the New Paclitaxel-eluting Balloon DIOR in Ostial Bifurcated Lesions)
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.
- Conditions
- Coronary Artery Disease
- Being tested
- DIOR drug-eluting PTCA balloon
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIOR drug-eluting PTCA balloonDevice
Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)
| Study group | Role | What they receive |
|---|---|---|
| Dior | Other | One arm observational registry using the Dior paclitaxel eluting balloon for the treatment of de novo ostial bifurcated lesions. Receives: Device: DIOR drug-eluting PTCA balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (4)
target vessel revascularization (TVR) rate, either symptom or ischemia-driven
Measured: 6 months
Segment treated thrombosis (STT), according to ARC definitions
Measured: 6 months
Late Lumen Loss
Late lumen loss determinated by control angiography
Measured: 6 months
Binary restenosis rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurocor GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Serra, MD, PhD, Principal investigator, Hospital Sant Pau, BarcelonaBeatriz Vaquerizo, MD, PhD, Principal investigator, Hospital Sant Pau, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375465
- Sponsor's protocol ID
- Eur-002
- Status last verified
- Sep 2013
- First submitted
- 16 Jun 2011
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 001-DIOR Multicenter Registry (A Novel Percutaneous Coronary Intervention With the New Paclitaxel-eluting Balloon DIOR in Ostial Bifurcated Lesions)
- ClinicalTrials.gov ID
- NCT01375465
- Acronym / sponsor ID
- Eur-002
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eurocor GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2013 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dior | Other | Device: DIOR drug-eluting PTCA balloonOne arm observational registry using the Dior paclitaxel eluting balloon for the treatment of de novo ostial bifurcated lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIOR drug-eluting PTCA balloonTreatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface) | Device | Dior |
Primary outcome
Major adverse cardiac events (MACE)
Time frame: 6 months
MACE rate defined as the rate of cardiac death and/or myocardial infarction (MI) and/or target lesion revascularization (TLR)
4 secondary outcomes
target vessel revascularization (TVR) rate, either symptom or ischemia-driven
Time frame: 6 months
Segment treated thrombosis (STT), according to ARC definitions
Time frame: 6 months
Late Lumen Loss
Time frame: 6 months
Binary restenosis rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Serra, MD, PhD principal investigator
Hospital Sant Pau, Barcelona
Beatriz Vaquerizo, MD, PhD principal investigator
Hospital Sant Pau, Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DIOR drug-eluting PTCA balloon in people with Coronary Artery Disease, run by Eurocor GmbH at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACE) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013.