Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
Sponsor: iVascular S.L.U.
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
Conditions
Interventions
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.
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™
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
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