Coronary Artery DiseaseROCCONCT01718106
Single Long vs Two Short Overlapping Bioabsorbable Polymer DES
A study testing implantation of a bioabsorbable polymer DES in people with Coronary Artery Disease, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long coronary stenoses but this strategy is expensive and the response to overlapping DES has not been extensively studied. 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?
- implantation of a bioabsorbable polymer DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2014to Mar 2016
- Phase
- Interventional
- 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 coronary artery stenosis in a major coronary artery branch (reference diameter 2.5-4.0 mm) with a lenght >28mm and <39mm
- Symptoms or instrumental evidence of myocardial ischemia:
- Chronic stable angina [Canadian Cardiovascular Society Classification]
- Unstable angina with ECG changes or troponin release (Braunwald Class IB-C, IIB-C, or IIIB-C)
- Stress ECG or myocardial perfusion imaging or stress echocardiography positive for inducible myocardial ischemia
- Written informed consent to the study
Who cannot join
- Pregnancy or lactation
- Acute ST elevation myocardial infarction (primary angioplasty)
- Cardiogenic shock
- Known allergic reactions to aspirin, clopidogrel, prasugrel, heparin, enoxaparin, bivalirudin, steel, chromium, iodiate contrast medium
- Platelets <75.000/mm3 or >700.000/mm3 or white blood cells <3.000/mm3.
- Partecipation to other studies.
Show all 14Show fewer
- Active or <3 months peptic ulcer or gastrointestinal bleeding
- Planned major surgery non delayable .
- Comorbidities limiting life expectancy to <1 year.
- Unprotected left main disease as target lesion
- Chronic total occlusion as target lesion
- Bifurcation with side branch > 2.5mm as target lesion
- Restenosis as target lesion
- saphenous vein graft as target lesion.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Maggiore della Carità
Novara, 28100
Alessandro Lupi, MD, +3903213733236, lupialessandro1@tin.it
Alessandro Lupi, MD
About this study
Official title: Randomized Study to Evaluate Segmental Late Loss Comparing Two PCI Strategies Using a Long Stent vs 2 Shorter Stents to Treat Long or Tandem Coronary Stenosis.
Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long coronary stenoses but this strategy is expensive and the response to overlapping DES has not been extensively studied. The recent availability of bioabsorbable polymer DES could allow treatment of long coronary stenoses without leaving gross burden of non-absorbable polymer in the vessel wall, even in case of overlapping stents.
Thus we planned to evaluate which of the 2 strategies, namely using a single long biabsorbable DES or two shorter biabsorbable DES with minimal overlapping, is better in treating long coronary stenoses.
The study is a spontanous randomized multicenter open-label study. A maximum of 300 patients with stable angina and at leat 1 coronary stenosis >28mm and <40mm of length will be randomized in 1:1 fashion by a Web-based electronic CRF. The long stent group (Group A) will be treated by a single 44mm Biomime DES (II generation DES with bioabsorbable polymer, Meril Life Sciences Pvt. Ltd., Gujarat, India). The short stent group (Group B) will be treated by 2 short Biomime DES positioned with minimal overlapping. The primary end-point of the study will be the 6 moth in-stent late lumen loss. Seconadry end-points will be 1, 6 and 12 month overall mortality, myocardial infarction, target vessel revascularization, stent thrombosis and MACE (combination of the 3 previous clinical end-points). Patients will be evaluated by 6-month control coronary angiography and late lumen loss in the stented vessel will be measured in a quantitative coronary angiography Core Lab (Cardioimaging Centre, Novara, Italy)
- Conditions
- Coronary Artery Disease
- Being tested
- implantation of a bioabsorbable polymer DES
- Keywords
- coronary artery disease, drug eluting stent, bioabsorbable polymer, percutaneous coronary intervention, restenosis, late thrombosis
- 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.
implantation of a bioabsorbable polymer DESDevice
implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES
| Study group | Role | What they receive |
|---|---|---|
| Single long bioabsorbable polymer DES | Active comparator | Patients with long coronary stenosis treated by a single long bioabsorbable polymer DES Receives: Device: implantation of a bioabsorbable polymer DES |
| Two bioabsorbable polymer DES in overlapping | Active comparator | patients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping Receives: Device: implantation of a bioabsorbable polymer DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
follow up in-stent late lumen loss
difference between the in-stent coronary lumen measure obtained immediately after coronary percutaneous intervention and the in-stent coronary lumen measure at follow up
Measured: 6-month
Secondary outcomes (5)
overall mortality
mortality for all causes
Measured: 1 year
Myocardial infarction
Myocardial infarction (universal definition of myocardial infarction, ACC/AHA/ESC statement) in the territory of the treated coronary artery
Measured: 1 year
target vessel revascularization
revascularization of the treated coronary vessel by repeated percutaneous coronary intervention or coronary artery bypass grafting due to restenosis and or symptoms or instrumental signs of myocardial ischemia
Measured: 1 year
Stent thrombosis
Coronary stent thrombosis according to ARC definition
Measured: 2 years
MACE (major coronary adverse event)
combined endpoint = presence of overall death or myocardial infarction or target vessel revascularization or stent thrombosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startMar 2014
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Alessandro Lupi, MD, Principal investigator, AOU Maggiore della Carità - NovaraAngelo S Bongo, MD, Study chair, AOU Maggiore della Carità - Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718106
- Sponsor's protocol ID
- 846/CE
- Acronym
- ROCCO
- Status last verified
- Mar 2015
- First submitted
- 27 Oct 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study to Evaluate Segmental Late Loss Comparing Two PCI Strategies Using a Long Stent vs 2 Shorter Stents to Treat Long or Tandem Coronary Stenosis.
- ClinicalTrials.gov ID
- NCT01718106
- Acronym / sponsor ID
- ROCCO / 846/CE
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, drug eluting stent, bioabsorbable polymer, percutaneous coronary intervention, restenosis, late thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 31 Oct 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.
Multiple overlapping drug-eluting coronary stents (DES) are usually needed to treat long coronary stenoses but this strategy is expensive and the response to overlapping DES has not been extensively studied. The recent availability of bioabsorbable polymer DES could allow treatment of long coronary stenoses without leaving gross burden of non-absorbable polymer in the vessel wall, even in case of overlapping stents.
Thus we planned to evaluate which of the 2 strategies, namely using a single long biabsorbable DES or two shorter biabsorbable DES with minimal overlapping, is better in treating long coronary stenoses.
The study is a spontanous randomized multicenter open-label study. A maximum of 300 patients with stable angina and at leat 1 coronary stenosis >28mm and <40mm of length will be randomized in 1:1 fashion by a Web-based electronic CRF. The long stent group (Group A) will be treated by a single 44mm Biomime DES (II generation DES with bioabsorbable polymer, Meril Life Sciences Pvt. Ltd., Gujarat, India). The short stent group (Group B) will be treated by 2 short Biomime DES positioned with minimal overlapping. The primary end-point of the study will be the 6 moth in-stent late lumen loss. Seconadry end-points will be 1, 6 and 12 month overall mortality, myocardial infarction, target vessel revascularization, stent thrombosis and MACE (combination of the 3 previous clinical end-points). Patients will be evaluated by 6-month control coronary angiography and late lumen loss in the stented vessel will be measured in a quantitative coronary angiography Core Lab (Cardioimaging Centre, Novara, Italy)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single long bioabsorbable polymer DES | Active comparator | Device: implantation of a bioabsorbable polymer DESPatients with long coronary stenosis treated by a single long bioabsorbable polymer DES |
| Two bioabsorbable polymer DES in overlapping | Active comparator | Device: implantation of a bioabsorbable polymer DESpatients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- De novo coronary artery stenosis in a major coronary artery branch (reference diameter 2.5-4.0 mm) with a lenght >28mm and <39mm
- Symptoms or instrumental evidence of myocardial ischemia:
- Written informed consent to the study
Key exclusion criteria (14 listed)
- Pregnancy or lactation
- Acute ST elevation myocardial infarction (primary angioplasty)
- Cardiogenic shock
- Known allergic reactions to aspirin, clopidogrel, prasugrel, heparin, enoxaparin, bivalirudin, steel, chromium, iodiate contrast medium
- Platelets <75.000/mm3 or >700.000/mm3 or white blood cells <3.000/mm3.
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 |
|---|---|---|
| implantation of a bioabsorbable polymer DESimplantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES | Device | Single long bioabsorbable polymer DES, Two bioabsorbable polymer DES in overlapping |
Primary outcome
follow up in-stent late lumen loss
Time frame: 6-month
difference between the in-stent coronary lumen measure obtained immediately after coronary percutaneous intervention and the in-stent coronary lumen measure at follow up
5 secondary outcomes
overall mortality
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
target vessel revascularization
Time frame: 1 year
Stent thrombosis
Time frame: 2 years
MACE (major coronary adverse event)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
Alessandro Lupi, MD principal investigator
AOU Maggiore della Carità - Novara
Angelo S Bongo, MD study chair
AOU Maggiore della Carità - Novara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implantation of a bioabsorbable polymer DES in people with Coronary Artery Disease, run by Azienda Ospedaliero Universitaria Maggiore della Carita 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 6 inclusion and 14 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 26 Mar 2015. 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.
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?
Contact Alessandro Lupi, MD (+3903213733236, lupialessandro1@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
follow up in-stent late lumen loss (time frame: 6-month). 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 26 Mar 2015.