Actively Recruiting
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
Led by iVascular S.L.U. · Updated on 2025-05-16
2312
Participants Needed
39
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 - < 95 years
- One or more coronary artery stenosis of 50% or more suitable for stent implantation with vessel diameter at least 2.00 mm
- Able to provide informed consent and willing to participate in the trial
You will not qualify if you...
- Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt
- Severe hepatic impairment (Child-Pugh stage C)
- Prior PCI within the last 45 days unrelated to this study
- Planned non-cardiac surgery during first month after PCI without maintained dual antiplatelet therapy
- Planned coronary artery bypass graft or other cardiac surgery after index PCI
- Active major bleeding or major surgery within last 30 days
- Stroke within 30 days prior to randomization
- Women of childbearing potential unless permanently sterile or postmenopausal
- Currently participating in another randomized controlled trial not yet at primary endpoint
- Life expectancy less than one year due to non-cardiovascular conditions
AI-Screening
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Trial Site Locations
Total: 39 locations
1
Olv Aalst
Aalst, Belgium
Actively Recruiting
2
IMELDA
Bonheiden, Belgium
Actively Recruiting
3
CHU Marie Curie
Charleroi, Belgium
Actively Recruiting
4
ZOL GENK
Genk, Belgium
Actively Recruiting
5
CHC Montlégia
Liège, Belgium
Actively Recruiting
6
Hospital de La Citadelle
Liège, Belgium
Actively Recruiting
7
Chu Ambroise Pare
Mons, Belgium
Actively Recruiting
8
Az Delta
Roeselare, Belgium
Actively Recruiting
9
Az Turnhout
Turnhout, Belgium
Actively Recruiting
10
Chu Lille
Lille, France
Actively Recruiting
11
Icps Massy
Massy, France
Actively Recruiting
12
Ipcs Quincy
Quincy-sous-Sénart, France
Actively Recruiting
13
Chu Toulouse
Toulouse, France
Actively Recruiting
14
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Actively Recruiting
15
Complejo Hospitalario Torrecárdenas
Almería, Spain
Actively Recruiting
16
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
17
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Actively Recruiting
18
Hospital Germans Trias I Pujol
Barcelona, Spain
Actively Recruiting
19
Hospital Universitario de Bellvitge
Barcelona, Spain
Actively Recruiting
20
Hospital Universitario Vall D'Hebrón
Barcelona, Spain
Actively Recruiting
21
Hospital San Pedro de Alcantara
Cáceres, Spain
Actively Recruiting
22
Hospital Universitario Juan Ramón Jiménez
Huelva, Spain
Actively Recruiting
23
Hospital Universitario Jerez de La Frontera
Jerez de la Frontera, Spain
Actively Recruiting
24
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Spain
Actively Recruiting
25
Hospital Universitario de León
León, Spain
Actively Recruiting
26
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
27
Hospital Universitario Puerta de Hierro
Madrid, Spain
Actively Recruiting
28
Hospital Universitario Regional de Málaga
Málaga, Spain
Actively Recruiting
29
Hospital Universitario Virgen de La Victoria
Málaga, Spain
Actively Recruiting
30
Hospital Clínico Universitario Virgen de La Arrixaca
Murcia, Spain
Actively Recruiting
31
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Actively Recruiting
32
Hospital de Navarra
Pamplona, Spain
Actively Recruiting
33
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Actively Recruiting
34
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain
Actively Recruiting
35
Hospital Clínico Universitario de Valencia
Valencia, Spain
Actively Recruiting
36
Hospital Universitario Y Politécnico La Fe
Valencia, Spain
Actively Recruiting
37
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Actively Recruiting
38
Hospital Álvaro Cunqueiro
Vigo, Spain
Actively Recruiting
39
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
Research Team
S
Sara Pich, PhD
CONTACT
A
Andrea Mancera
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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