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

PHASE3RecruitingINTERVENTIONAL
Enrollment

2,312

Participants

Timeline

Start Date

October 13, 2023

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2030

Conditions
Coronary Artery Disease
Interventions
DEVICE

Angiolite: Sirolimus-eluting stent

The angiolite stent (iVascular, Barcelona, Spain) is a thin-strut cobalt-chromium sirolimus-eluting stent with an open-cell design containing a durable biostable coating composed of three layers - acrylate to ensure adhesion to the metal surface, fluoroacrylate that carries the sirolimus, and a top layer of fluoroacrylate to control drug release.

DEVICE

Xience: Everolimus-eluting stent

The Xience stent family (Abbott vascular, California, United States of America), characterized by an L-605 cobalt-chromium (CoCr) is a thin-strut cobalt-chromium everolimus-eluting stent with an open-cell design containing a nonerodable polymer made of PBMA, a reservoir made of a fluorinated copolymer of vinylidene fluoride and hexafluoropropylene monomers. Xience™ stent family includes XIENCE Skypoint™ and XIENCE Sierra™

DRUG

1-month DAPT

"DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Then, only the same oral P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor) up to 12 months.~The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC"

DRUG

12-month DAPT (Standard of care)

DAPT with acetylsalicylic acid and prasugrel or ticagrelor up to 12 months. The type of agent and treatment duration will be selected according to the clinical characteristic of the patient: Acute coronary syndrome or Chronic coronary syndrome and Need for OAC or No need for OAC

Trial Locations (39)

Unknown

RECRUITING

Olv Aalst, Aalst

RECRUITING

IMELDA, Bonheiden

RECRUITING

CHU Marie Curie, Charleroi

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ZOL GENK, Genk

RECRUITING

CHC Montlégia, Liège

RECRUITING

Hospital de La Citadelle, Liège

RECRUITING

Chu Ambroise Pare, Mons

RECRUITING

Az Delta, Roeselare

RECRUITING

Az Turnhout, Turnhout

RECRUITING

Chu Lille, Lille

RECRUITING

Icps Massy, Massy

RECRUITING

Ipcs Quincy, Quincy-sous-Sénart

RECRUITING

Chu Toulouse, Toulouse

RECRUITING

Complejo Hospitalario Universitario A Coruña, A Coruña

RECRUITING

Complejo Hospitalario Torrecárdenas, Almería

RECRUITING

Hospital Clínic de Barcelona, Barcelona

RECRUITING

Hospital de La Santa Creu I Sant Pau, Barcelona

RECRUITING

Hospital Germans Trias I Pujol, Barcelona

RECRUITING

Hospital Universitario de Bellvitge, Barcelona

RECRUITING

Hospital Universitario Vall D'Hebrón, Barcelona

RECRUITING

Hospital San Pedro de Alcantara, Cáceres

RECRUITING

Hospital Universitario Juan Ramón Jiménez, Huelva

RECRUITING

Hospital Universitario Jerez de La Frontera, Jerez de la Frontera

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria

RECRUITING

Hospital Universitario de León, León

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

RECRUITING

Hospital Universitario Puerta de Hierro, Madrid

RECRUITING

Hospital Universitario Regional de Málaga, Málaga

RECRUITING

Hospital Universitario Virgen de La Victoria, Málaga

RECRUITING

Hospital Clínico Universitario Virgen de La Arrixaca, Murcia

RECRUITING

Hospital Universitari Son Espases, Palma de Mallorca

RECRUITING

Hospital de Navarra, Pamplona

RECRUITING

Hospital Universitario Marqués de Valdecilla, Santander

RECRUITING

Hospital Clínico Universitario de Santiago, Santiago de Compostela

RECRUITING

Hospital Clínico Universitario de Valencia, Valencia

RECRUITING

Hospital Universitario Y Politécnico La Fe, Valencia

RECRUITING

Hospital Clínico Universitario de Valladolid, Valladolid

RECRUITING

Hospital Álvaro Cunqueiro, Vigo

RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

All Listed Sponsors
lead

iVascular S.L.U.

INDUSTRY