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RECRUITING
NCT05952206
PHASE3

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

Sponsor: iVascular S.L.U.

View on ClinicalTrials.gov

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.

Official title: Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy. A 2x2 Factorial, All-comer, Multicenter, Randomized Controlled Trial: ANGIODAPT

Key Details

Gender

All

Age Range

18 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

2312

Start Date

2023-10-13

Completion Date

2030-08

Last Updated

2025-05-16

Healthy Volunteers

No

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

Locations (39)

Olv Aalst

Aalst, Belgium

IMELDA

Bonheiden, Belgium

CHU Marie Curie

Charleroi, Belgium

ZOL GENK

Genk, Belgium

CHC Montlégia

Liège, Belgium

Hospital de La Citadelle

Liège, Belgium

Chu Ambroise Pare

Mons, Belgium

Az Delta

Roeselare, Belgium

Az Turnhout

Turnhout, Belgium

Chu Lille

Lille, France

Icps Massy

Massy, France

Ipcs Quincy

Quincy-sous-Sénart, France

Chu Toulouse

Toulouse, France

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Complejo Hospitalario Torrecárdenas

Almería, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Hospital Germans Trias I Pujol

Barcelona, Spain

Hospital Universitario de Bellvitge

Barcelona, Spain

Hospital Universitario Vall D'Hebrón

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Universitario Juan Ramón Jiménez

Huelva, Spain

Hospital Universitario Jerez de La Frontera

Jerez de la Frontera, Spain

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain

Hospital Universitario de León

León, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Universitario Regional de Málaga

Málaga, Spain

Hospital Universitario Virgen de La Victoria

Málaga, Spain

Hospital Clínico Universitario Virgen de La Arrixaca

Murcia, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Spain

Hospital de Navarra

Pamplona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Universitario Y Politécnico La Fe

Valencia, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Hospital Álvaro Cunqueiro

Vigo, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain