Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy

Last updated: May 13, 2025
Sponsor: iVascular S.L.U.
Overall Status: Active - Recruiting

Phase

3

Condition

Coronary Artery Disease

Cardiac Disease

Thrombosis

Treatment

12-month DAPT (Standard of care)

Xience: Sirolimus-eluting stent

Xience: Everolimus-eluting stent

Clinical Study ID

NCT05952206
ANGIODAPT-01
  • Ages 18-95
  • All Genders

Study Summary

Factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Immediately after the first randomization, the study compares (second randomization) the superiority in bleeding Bleeding Academic Research Consortium (BARC) 2, 3, or 5 of abbreviated DAPT versus standard of care. Both primary endpoints will be evaluated at 12 months of follow-up. The study will be open-label for the stent type and the antiplatelet regimen.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 - < 95 years;

  • Presence of one or more coronary artery stenosis of 50% or more in a native coronaryartery or in a saphenous venous or arterial bypass conduit suitable for coronarystent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length);

  • Able to provide informed consent and willing to participate in the trial.

Exclusion

Exclusion Criteria:

  • Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel,or ticagrelor), sirolimus, everolimus, or chromium-cobalt.;

  • Known severe hepatic impairment Child-Pug stage C;

  • Prior PCI (not related to the study) performed in the last 45 days;

  • Planned non-cardiac surgery during the first month after PCI, unless dualantiplatelet therapy is maintained throughout the peri-surgical period;

  • Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvularfor instance) following index PCI;

  • Active major bleeding or major surgery within the last 30 days;

  • Known stroke (any type) within the 30 days prior to the randomization;

  • Women of childbearing potential being defined as woman from the onset ofmenstruation (menarche) until they become postmenopausal, unless they arepermanently sterile. A postmenopausal state is clarified as having no menstrualperiods for 12 consecutive months without any other medical cause. Women who haveundergone permanent sterilization methods, including hysterectomy, bilateralsalpingectomy, and bilateral oophorectomy, can be enrolled in the study

  • Currently participating in another randomized controlled trial and not yet at itsprimary endpoint;

  • Life expectancy less than one year due to non-cardiovascular comorbidity.

Study Design

Total Participants: 2312
Treatment Group(s): 5
Primary Treatment: 12-month DAPT (Standard of care)
Phase: 3
Study Start date:
October 13, 2023
Estimated Completion Date:
August 31, 2030

Connect with a study center

  • Olv Aalst

    Aalst,
    Belgium

    Active - Recruiting

  • IMELDA

    Bonheiden,
    Belgium

    Active - Recruiting

  • CHU Marie Curie

    Charleroi,
    Belgium

    Active - Recruiting

  • ZOL GENK

    Genk,
    Belgium

    Active - Recruiting

  • CHC Montlégia

    Liège,
    Belgium

    Active - Recruiting

  • Hospital de La Citadelle

    Liège,
    Belgium

    Active - Recruiting

  • Chu Ambroise Pare

    Mons,
    Belgium

    Active - Recruiting

  • Az Delta

    Roeselare,
    Belgium

    Active - Recruiting

  • Az Turnhout

    Turnhout,
    Belgium

    Active - Recruiting

  • Chu Lille

    Lille,
    France

    Active - Recruiting

  • Icps Massy

    Massy,
    France

    Active - Recruiting

  • Ipcs Quincy

    Quincy-sous-Sénart,
    France

    Active - Recruiting

  • Chu Toulouse

    Toulouse,
    France

    Active - Recruiting

  • Complejo Hospitalario Universitario A Coruña

    A Coruña,
    Spain

    Active - Recruiting

  • Complejo Hospitalario Torrecárdenas

    Almería,
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Germans Trias I Pujol

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Vall D'Hebrón

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital de La Santa Creu I Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital San Pedro de Alcantara

    Cáceres,
    Spain

    Active - Recruiting

  • Hospital Universitario Juan Ramón Jiménez

    Huelva,
    Spain

    Active - Recruiting

  • Hospital Universitario Jerez de La Frontera

    Jerez De La Frontera,
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria,
    Spain

    Active - Recruiting

  • Hospital Universitario de León

    León,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de La Arrixaca

    Murcia,
    Spain

    Active - Recruiting

  • Hospital Universitario Regional de Málaga

    Málaga,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de La Victoria

    Málaga,
    Spain

    Active - Recruiting

  • Hospital Universitari Son Espases

    Palma De Mallorca,
    Spain

    Active - Recruiting

  • Hospital de Navarra

    Pamplona,
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Santiago

    Santiago De Compostela,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia,
    Spain

    Active - Recruiting

  • Hospital Universitario Y Politécnico La Fe

    Valencia,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunqueiro

    Vigo,
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza,
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.