Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.
NCT ID: NCT02099617
Last Updated: 2024-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1200 participants
INTERVENTIONAL
2014-05-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Drug Eluting Stent
Synergy II
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent
Bare Metal Stent
Omega or Rebel
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent
Interventions
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Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent
Eligibility Criteria
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Inclusion Criteria
* 2- One or more significant coronary artery stenosis is/are present (defined as ≥70% by visual assessment or ≥50% with Fractional Flow Reserve \<0.80) or a left main coronary stenosis ≥50% by visual assessment) suitable for PCI with one of the following present:
* a -Silent ischemia,
* stress-induced myocardial ischemia ≥ 10% of myocardium in a asymptomatic patient or
* stress-induced myocardial ischemia \< 10% of myocardium AND FFR (Fractional Flow Reserve) ≤0.80 or
* b - Stable angina, in a patient with objective ischemia despite optimal medical therapy or
* c - acute coronary syndrome including: unstable angina, non ST- and ST elevation myocardial infarction.
* 3- All patients must also sign informed consent as per local law and comply with all study process during follow up for at least one year.
Exclusion Criteria
* 2- Indication for myocardial revascularization by coronary artery bypass grafting,
* 3- Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one month (stable angina or silent ischemia) or at least six month (acute coronary syndrome),
* 4- Subjects requiring additional surgery (cardiac or non-cardiac) within one month,
* 5- Non cardiac co-morbidities with life expectancy less than 1 year,
* 6- Prior hemorrhagic stroke,
* 7- Known allergy to aspirin or P2Y12 inhibitors,
* 8- At least one contra indication to ALL the authorized P2Y12 inhibitors at the requested dose (in case of contra indication to only one of two of the P2Y12 inhibitors, the investigators are allowed to use the P2Y12 inhibitors for which no allergy is known).
* 9- Silent ischemia \<10% of the myocardium with FFR ≥0.80.
* 10- Participation in another clinical trial
75 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Ceric Sàrl
INDUSTRY
Responsible Party
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Locations
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CHU St Pierre
Brussels, , Belgium
Centre Hospitalier de Jolimont
La Louvière, , Belgium
UZ Leuven
Leuven, , Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, , Belgium
Oulu University Hospital
Oulu, , Finland
Heary Center - Satakunta Centyral Hospital
Pori, , Finland
Hôpital Ambroise Paré
Boulogne-Billancourt, , France
Hôpital Henri Mondor
Créteil, , France
Hôpital de la Timone
Marseille, , France
Hôpital Privé Jacques Cartier
Massy, , France
Polyclinique les Fleurs
Ollioules, , France
Hôpital Lariboisière
Paris, , France
Hôpital La Pitié-Salpêtrière
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Privé Claude Galien
Quincy-sous-Sénart, , France
CHU Toulouse Rangueil
Toulouse, , France
ARNAS civico
Palermo, , Italy
Pauls Stradins Clinical University Hospital
Riga, , Latvia
University Clinic of Cardiology - Medical Faculty
Skopje, , North Macedonia
Hospital universitario Marquès de Valdecilla
Santander, Cantabria, Spain
Hospital San Juan de Alicante
Alicante, Valencia, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Universati Germans Trias i Pujol
Badalona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clinic
Barcelona, , Spain
Hospital de la Santa Creu i Sant pau
Barcelona, , Spain
Hospital Juan Roamon Jimenez
Huelva, , Spain
Hospital Universitario virgen de la arrixaca
Murcia, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital virgen de la salud.
Toledo, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Hospital Meixoiero
Vigo, , Spain
Hôpital Fribourgeois
Fribourg, , Switzerland
Centre hospitalier universitaire vaudois
Lausanne, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Brighton and Sussex Hospitals
Brighton, , United Kingdom
Craigavon Cardiac Center
Craigavon, , United Kingdom
Guy's and St.Thomas'Hospitals
London, , United Kingdom
King's College London
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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Varenne O, Cook S, Sideris G, Kedev S, Cuisset T, Carrie D, Hovasse T, Garot P, El Mahmoud R, Spaulding C, Helft G, Diaz Fernandez JF, Brugaletta S, Pinar-Bermudez E, Mauri Ferre J, Commeau P, Teiger E, Bogaerts K, Sabate M, Morice MC, Sinnaeve PR; SENIOR investigators. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet. 2018 Jan 6;391(10115):41-50. doi: 10.1016/S0140-6736(17)32713-7. Epub 2017 Nov 1.
Other Identifiers
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10-389
Identifier Type: -
Identifier Source: org_study_id
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