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.

Last updated: January 11, 2024
Sponsor: Ceric Sàrl
Overall Status: Completed

Phase

N/A

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

NCT02099617
10-389
  • Ages > 75
  • All Genders

Study Summary

The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to significant coronary artery disease and requiring percutaneous coronary intervention. The primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated with a lower rate of the composite rate of major cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.

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

Total Participants: 1200
Treatment Group(s): 3
Primary Treatment: Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent
Phase:
Study Start date:
May 01, 2014
Estimated Completion Date:
June 30, 2018

Connect with a study center

  • CHU St Pierre

    Brussels, 1150
    Belgium

    Site Not Available

  • Centre Hospitalier de Jolimont

    La Louvière, 7100
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • CHU de Liège - Domaine Universitaire du Sart Tilman

    Liège 1, 4000
    Belgium

    Site Not Available

  • Oulu University Hospital

    Oulu, 90220
    Finland

    Site Not Available

  • Heary Center - Satakunta Centyral Hospital

    Pori,
    Finland

    Site Not Available

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, 92100
    France

    Site Not Available

  • Hôpital Henri Mondor

    Créteil, 94000
    France

    Site Not Available

  • Hôpital de la Timone

    Marseille, 13005
    France

    Site Not Available

  • Hôpital Privé Jacques Cartier

    Massy, 91300
    France

    Site Not Available

  • Polyclinique les Fleurs

    Ollioules, 83 190
    France

    Site Not Available

  • Hôpital Cochin

    Paris, 75014
    France

    Site Not Available

  • Hôpital Européen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Hôpital La Pitié-Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • Hôpital Lariboisière

    Paris, 75010
    France

    Site Not Available

  • Hôpital Privé Claude Galien

    Quincy sous Sénart, 91480
    France

    Site Not Available

  • CHU Toulouse Rangueil

    Toulouse, 31400
    France

    Site Not Available

  • ARNAS civico

    Palermo, 90127
    Italy

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002
    Latvia

    Site Not Available

  • University Clinic of Cardiology - Medical Faculty

    Skopje, 1000
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • University Clinic of Cardiology - Medical Faculty

    Skopje, 1000
    North Macedonia

    Site Not Available

  • Hospital universitario Marquès de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital San Juan de Alicante

    Alicante, Valencia
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario A Coruña

    A Coruna, 08003
    Spain

    Site Not Available

  • Hospital Universati Germans Trias i Pujol

    Badalona,
    Spain

    Site Not Available

  • Hospital Clinic

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Juan Roamon Jimenez

    Huelva, 21005
    Spain

    Site Not Available

  • Hospital Universitario virgen de la arrixaca

    Murcia, 30107
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital virgen de la salud.

    Toledo, 45071
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005
    Spain

    Site Not Available

  • Hospital Meixoiero

    Vigo, 36200
    Spain

    Site Not Available

  • Hôpital Fribourgeois

    Fribourg, 1708
    Switzerland

    Site Not Available

  • Centre hospitalier universitaire vaudois

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Luzerner Kantonsspital

    Luzern, 6000
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen

    St.Gallen, 9007
    Switzerland

    Site Not Available

  • Kantonsspital Winterthur

    Winterthur,
    Switzerland

    Site Not Available

  • Brighton and Sussex Hospitals

    Brighton, BN2 1ES
    United Kingdom

    Site Not Available

  • Craigavon Cardiac Center

    Craigavon, BT62 5QQ
    United Kingdom

    Site Not Available

  • Guy's and St.Thomas'Hospitals

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • King's College London

    London, SE5 9PJ
    United Kingdom

    Site Not Available

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

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