Single Long vs Two Short Overlapping Bioabsorbable Polymer DES (ROCCO)
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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Novara, Italia, 28100
- Rekruttering
- Ospedale Maggiore della Carità
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Ta kontakt med:
- Alessandro Lupi, MD
- Telefonnummer: +3903213733236
- E-post: lupialessandro1@tin.it
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Hovedetterforsker:
- Alessandro Lupi, MD
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Underetterforsker:
- Andrea Rognoni, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Single long bioabsorbable polymer DES
Patients with long coronary stenosis treated by a single long bioabsorbable polymer DES
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implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES
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Aktiv komparator: Two bioabsorbable polymer DES in overlapping
patients with long coronary artery stenosis tretaed by 2 bioabsorbable polymer DES with minimal overlapping
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implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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follow up in-stent late lumen loss
Tidsramme: 6-month
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difference between the in-stent coronary lumen measure obtained immediately after coronary percutaneous intervention and the in-stent coronary lumen measure at follow up
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6-month
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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overall mortality
Tidsramme: 1 year
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mortality for all causes
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1 year
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Myocardial infarction
Tidsramme: 1 year
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Myocardial infarction (universal definition of myocardial infarction, ACC/AHA/ESC statement) in the territory of the treated coronary artery
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1 year
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target vessel revascularization
Tidsramme: 1 year
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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
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1 year
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Stent thrombosis
Tidsramme: 2 years
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Coronary stent thrombosis according to ARC definition
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2 years
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MACE (major coronary adverse event)
Tidsramme: 1 year
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combined endpoint = presence of overall death or myocardial infarction or target vessel revascularization or stent thrombosis
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1 year
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Alessandro Lupi, MD, AOU Maggiore della Carità - Novara
- Studiestol: Angelo S Bongo, MD, AOU Maggiore della Carità - Novara
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Først innsendt som oppfylte QC-kriteriene
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Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 846/CE
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