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NCT05952206Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 15 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2312 (actual)
First submitted
24 May 2023
Start date
13 Oct 2023
Primary completion date
13 Jan 2027
Lead sponsor
iVascular S.L.U.
NCT number
NCT05952206
EU CT number
2023-507015-35-00
EudraCT number
2021-003906-34

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 2312
  • From 13 Oct 2023 to the primary completion date, 13 Jan 2027
  • 38 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.;
  • Prior PCI (not related to the study) performed in the last 45 days;
  • Known stroke (any type) within the 30 days prior to the randomization;

Other illness

  • Known severe hepatic impairment Child-Pug stage C;
  • Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
  • Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI;
  • Active major bleeding or major surgery within the last 30 days;

Other

  • Women of childbearing potential being defined as woman from the onset of menstruation (menarche) until they become postmenopausal, unless they are permanently sterile. A postmenopausal state is clarified as having no menstrual periods for 12 consecutive months without any other medical cause. Women who have undergone permanent sterilization methods, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, can be enrolled in the study
  • Currently participating in another randomized controlled trial and not yet at its primary endpoint;
  • Life expectancy less than one year due to non-cardiovascular comorbidity.

Who the study is looking for

  • Age \>18 - \< 95 years;
  • Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent 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.

Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital de la Citadelle
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4000 LiègeBelgiumActive, not recruiting
Imelda Hospital Bonheiden
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BonheidenBelgiumActive, not recruiting
HC Marie Curie
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CharleroiBelgiumActive, not recruiting
CHC MontLégia
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LiègeBelgiumActive, not recruiting
CHU Mons University Clinic
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MonsBelgiumActive, not recruiting
AZ Delta uw Ziekenhuis Campus Rumbeke, campus Brugsesteenweg Roeselare
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RoselareBelgiumActive, not recruiting
AZ Turnhout
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TurnhoutBelgiumActive, not recruiting
Ziekenhuis Oost-Limburg Genk
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GenkGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Universitario Torrecárdenas
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AlmeríaSpainActive, not recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital San Pedro De Alcántara
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CáceresSpainActive, not recruiting
Hospital Universitario Juan Ramon Jimenez
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HuelvaSpainActive, not recruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainActive, not recruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainActive, not recruiting
Hospital Universitario De Leon
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LeónSpainActive, not recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
University Hospital Son Espases
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PalmaSpainActive, not recruiting
Hospital Universitario de Navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainActive, not recruiting
Complexo Hospitalario Universitario De Vigo
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VigoSpainActive, not recruiting
Hospital Unviersitario Miguel Servet
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ZaragozaSpainActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Hopital Jaques Cartier Massy
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MassyFranceActive, not recruiting
Hotel Prive Claude Galien, Quincy Sous
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quincy sous senartFranceActive, not recruiting
CHU de Toulouse - Hopital Rangueil
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ToulouseFranceActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.