Phase
Condition
Angina
Hypercholesterolemia
Coronary Artery Disease
Treatment
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent
Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent
Clinical Study ID
Ages > 75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 1- Patient is ≥ 75 years old
- 2- One or more significant coronary artery stenosis is/are present (defined as ≥70% byvisual assessment or ≥50% with Fractional Flow Reserve <0.80) or a left main coronarystenosis ≥50% by visual assessment) suitable for PCI with one of the followingpresent:
- 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 FlowReserve) ≤0.80 or
- b - Stable angina, in a patient with objective ischemia despite optimal medicaltherapy or
- c - acute coronary syndrome including: unstable angina, non ST- and ST elevationmyocardial infarction.
- 3- All patients must also sign informed consent as per local law and comply with allstudy process during follow up for at least one year.
Exclusion
Exclusion Criteria:
- 1- The subject is not eligible for randomization if ANY of the following is present:
- 2- Indication for myocardial revascularization by coronary artery bypass grafting,
- 3- Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for atleast one month (stable angina or silent ischemia) or at least six month (acutecoronary 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 therequested dose (in case of contra indication to only one of two of the P2Y12inhibitors, the investigators are allowed to use the P2Y12 inhibitors for which noallergy is known).
- 9- Silent ischemia <10% of the myocardium with FFR ≥0.80.
- 10- Participation in another clinical trial
Study Design
Connect with a study center
CHU St Pierre
Brussels, 1150
BelgiumSite Not Available
Centre Hospitalier de Jolimont
La Louvière, 7100
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège 1, 4000
BelgiumSite Not Available
Oulu University Hospital
Oulu, 90220
FinlandSite Not Available
Heary Center - Satakunta Centyral Hospital
Pori,
FinlandSite Not Available
Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
FranceSite Not Available
Hôpital Henri Mondor
Créteil, 94000
FranceSite Not Available
Hôpital de la Timone
Marseille, 13005
FranceSite Not Available
Hôpital Privé Jacques Cartier
Massy, 91300
FranceSite Not Available
Polyclinique les Fleurs
Ollioules, 83 190
FranceSite Not Available
Hôpital Cochin
Paris, 75014
FranceSite Not Available
Hôpital Européen Georges Pompidou
Paris, 75015
FranceSite Not Available
Hôpital La Pitié-Salpêtrière
Paris, 75013
FranceSite Not Available
Hôpital Lariboisière
Paris, 75010
FranceSite Not Available
Hôpital Privé Claude Galien
Quincy sous Sénart, 91480
FranceSite Not Available
CHU Toulouse Rangueil
Toulouse, 31400
FranceSite Not Available
ARNAS civico
Palermo, 90127
ItalySite Not Available
Pauls Stradins Clinical University Hospital
Riga, LV-1002
LatviaSite Not Available
University Clinic of Cardiology - Medical Faculty
Skopje, 1000
Macedonia, The Former Yugoslav Republic ofSite Not Available
University Clinic of Cardiology - Medical Faculty
Skopje, 1000
North MacedoniaSite Not Available
Hospital universitario Marquès de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital San Juan de Alicante
Alicante, Valencia
SpainSite Not Available
Complexo Hospitalario Universitario A Coruña
A Coruna, 08003
SpainSite Not Available
Hospital Universati Germans Trias i Pujol
Badalona,
SpainSite Not Available
Hospital Clinic
Barcelona, 08036
SpainSite Not Available
Hospital de la Santa Creu i Sant pau
Barcelona,
SpainSite Not Available
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
Hospital Juan Roamon Jimenez
Huelva, 21005
SpainSite Not Available
Hospital Universitario virgen de la arrixaca
Murcia, 30107
SpainSite Not Available
Hospital Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
Hospital virgen de la salud.
Toledo, 45071
SpainSite Not Available
Hospital Clinico Universitario de Valladolid
Valladolid, 47005
SpainSite Not Available
Hospital Meixoiero
Vigo, 36200
SpainSite Not Available
Hôpital Fribourgeois
Fribourg, 1708
SwitzerlandSite Not Available
Centre hospitalier universitaire vaudois
Lausanne, 1011
SwitzerlandSite Not Available
Luzerner Kantonsspital
Luzern, 6000
SwitzerlandSite Not Available
Kantonsspital St. Gallen
St.Gallen, 9007
SwitzerlandSite Not Available
Kantonsspital Winterthur
Winterthur,
SwitzerlandSite Not Available
Brighton and Sussex Hospitals
Brighton, BN2 1ES
United KingdomSite Not Available
Craigavon Cardiac Center
Craigavon, BT62 5QQ
United KingdomSite Not Available
Guy's and St.Thomas'Hospitals
London, SE1 7EH
United KingdomSite Not Available
King's College London
London, SE5 9PJ
United KingdomSite Not Available
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
United KingdomSite Not Available
New Cross Hospital
Wolverhampton, WV10 0QP
United KingdomSite Not Available

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