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)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Novara, Italië, 28100
- Werving
- Ospedale Maggiore della Carità
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Contact:
- Alessandro Lupi, MD
- Telefoonnummer: +3903213733236
- E-mail: lupialessandro1@tin.it
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Hoofdonderzoeker:
- Alessandro Lupi, MD
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Onderonderzoeker:
- Andrea Rognoni, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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follow up in-stent late lumen loss
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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overall mortality
Tijdsspanne: 1 year
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mortality for all causes
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1 year
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Myocardial infarction
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Alessandro Lupi, MD, AOU Maggiore della Carità - Novara
- Studie stoel: Angelo S Bongo, MD, AOU Maggiore della Carità - Novara
Publicaties en nuttige links
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Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 846/CE
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