Myocardial IschemiaPhase 4ELICOPTERNCT01637896
A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation
A Phase 4 study testing DEB+BMS and POBA+DES in people with Myocardial Ischemia, run by Leonardo Bolognese, MD at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- DEB+BMS and POBA+DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Jul 2012
- 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
- age> 18 years
- angina or stress test positive for ischemia
- de novo coronary stenosis>50%
Who cannot join
- recent myocardial infarction (<72h)
- severe chronic kidney disease
- allergy to Paclitaxel
- contraindication for combined antiplatelet treatment
- life expectancy <1 year
- hypersensitivity or contraindication to one of the study drugs
- lack of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial
The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis
- Conditions
- Myocardial Ischemia
- Being tested
- DEB+BMS, POBA+DES
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB+BMSDevice
drug-eluting balloon predilation and bare metal stent implantation
POBA+DESDevice
conventional balloon predilation and drug-eluting stent implantation
| Study group | Role | What they receive |
|---|---|---|
| DEB+BMS | Experimental | drug-eluting balloon predilation and bare metal stent implantation Receives: Device: DEB+BMS |
| POBA+DES | Active comparator | conventional balloon predilation and drug-eluting stent implantation Receives: Device: POBA+DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
angiographic binary re-restenosis
incidence of angiographic binary re-restenosis
Measured: 9 months
Secondary outcomes (2)
Late luminal loss
incidence of late luminal loss assessed by angiography
Measured: 9 months
major adverse cardiac events
incidence of major adverse cardiac events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionJul 2012
Why it stopped: the study was halted after an interim analysis perfomed for a perceived excess of target vessel revascularization in the DEB+BMS arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonardo Bolognese, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leonardo Bolognese, MD, Ospedale San Donato
- Investigators
- Leonardo Bolognese, MD, Principal investigator, San Donato Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637896
- Sponsor's protocol ID
- Arezzo000
- Acronym
- ELICOPTER
- Status last verified
- Jul 2012
- First submitted
- 7 Jul 2012
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation: the ELICOPTER Trial
- ClinicalTrials.gov ID
- NCT01637896
- Acronym / sponsor ID
- ELICOPTER / Arezzo000
- Conditions
- Myocardial Ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study was halted after an interim analysis perfomed for a perceived excess of target vessel revascularization in the DEB+BMS arm
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Leonardo Bolognese, MDUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Jul 2012 (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 purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB+BMS | Experimental | Device: DEB+BMSdrug-eluting balloon predilation and bare metal stent implantation |
| POBA+DES | Active comparator | Device: POBA+DESconventional balloon predilation and drug-eluting stent implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age> 18 years
- angina or stress test positive for ischemia
- de novo coronary stenosis>50%
Key exclusion criteria (7 listed)
- recent myocardial infarction (<72h)
- severe chronic kidney disease
- allergy to Paclitaxel
- contraindication for combined antiplatelet treatment
- life expectancy <1 year
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 |
|---|---|---|
| DEB+BMSdrug-eluting balloon predilation and bare metal stent implantation | Device | DEB+BMS |
| POBA+DESconventional balloon predilation and drug-eluting stent implantation | Device | POBA+DES |
Primary outcome
angiographic binary re-restenosis
Time frame: 9 months
incidence of angiographic binary re-restenosis
2 secondary outcomes
Late luminal loss
Time frame: 9 months
major adverse cardiac events
Time frame: 12 months
Results and safety
The study was stopped early (reason given: the study was halted after an interim analysis perfomed for a perceived excess of target vessel revascularization in the DEB+BMS arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
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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.
Leonardo Bolognese, MD principal investigator
San Donato Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEB+BMS and POBA+DES in people with Myocardial Ischemia, run by Leonardo Bolognese, MD at 1 site in Italy.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study was stopped early (reason given: the study was halted after an interim analysis perfomed for a perceived excess of target vessel revascularization in the DEB+BMS arm). 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?
angiographic binary re-restenosis (time frame: 9 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 12 Jul 2012.