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.
- Diseases
- Coronary artery disease
- 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
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital de la Citadelle Coordinator of this site? Confirm its status | 4000 Liège | Belgium | Active, not recruiting |
| Imelda Hospital Bonheiden Coordinator of this site? Confirm its status | Bonheiden | Belgium | Active, not recruiting |
| HC Marie Curie Coordinator of this site? Confirm its status | Charleroi | Belgium | Active, not recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| CHU Mons University Clinic Coordinator of this site? Confirm its status | Mons | Belgium | Active, not recruiting |
| AZ Delta uw Ziekenhuis Campus Rumbeke, campus Brugsesteenweg Roeselare Coordinator of this site? Confirm its status | Roselare | Belgium | Active, not recruiting |
| AZ Turnhout Coordinator of this site? Confirm its status | Turnhout | Belgium | Active, not recruiting |
| Ziekenhuis Oost-Limburg Genk Coordinator of this site? Confirm its status | Genk | Germany | Active, not recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Hospital Universitario Torrecárdenas Coordinator of this site? Confirm its status | Almería | Spain | Active, not recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Active, not recruiting |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Active, not recruiting |
| Hospital de Jerez de la Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Active, not recruiting |
| El Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas De Gran Canaria | Spain | Active, not recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Active, not recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Active, not recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Active, not recruiting |
| Hospital Unviersitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Hopital Jaques Cartier Massy Coordinator of this site? Confirm its status | Massy | France | Active, not recruiting |
| Hotel Prive Claude Galien, Quincy Sous Coordinator of this site? Confirm its status | quincy sous senart | France | Active, not recruiting |
| CHU de Toulouse - Hopital Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.