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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Angiolite: Sirolimus-eluting stent; Drug: 1-month DAPT; Drug: 12-month DAPT (Standard of care); Device: Xience: Everolimus-eluting stent

• Study Type: Interventional
• Enrollment (Actual): 2312
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium
    • IMELDA
  • Charleroi, Belgium
    • CHU Marie Curie
  • Genk, Belgium
    • ZOL GENK
  • Liège, Belgium
    • CHC MontLegia
  • Liège, Belgium
    • Hospital de La Citadelle
  • Mons, Belgium
    • CHU Ambroise Pare
  • Roeselare, Belgium
    • AZ Delta
  • Turnhout, Belgium
    • AZ Turnhout
• France
  • Lille, France
    • Chu Lille
  • Massy, France
    • Icps Massy
  • Quincy-sous-Sénart, France
    • Ipcs Quincy
  • Toulouse, France
    • CHU Toulouse
• Spain
  • A Coruña, Spain
    • Complejo Hospitalario Universitario A Coruña
  • Almería, Spain
    • Complejo Hospitalario Torrecárdenas
  • Barcelona, Spain
    • Hospital Clinic de Barcelona
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain
    • Hospital Universitario de Bellvitge
  • Barcelona, Spain
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain
    • Hospital Universitario Vall d'Hebron
  • Cáceres, Spain
    • Hospital San Pedro De Alcantara
  • Huelva, Spain
    • Hospital Universitario Juan Ramon Jimenez
  • Jerez de la Frontera, Spain
    • Hospital Universitario Jerez de la Frontera
  • Las Palmas de Gran Canaria, Spain
    • Hospital Universitario de Gran Canaria Doctor Negrín
  • León, Spain
    • Hospital Universitario de Leon
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Universitario Puerta de Hierro
  • Murcia, Spain
    • Hospital Clinico Universitario Virgen de la Arrixaca
  • Málaga, Spain
    • Hospital Universitario Virgen de la Victoria
  • Málaga, Spain
    • Hospital Universitario Regional de Malaga
  • Palma de Mallorca, Spain
    • Hospital Universitari Son Espases
  • Pamplona, Spain
    • Hospital de Navarra
  • Santander, Spain
    • Hospital Universitario Marqués de Valdecilla
  • Santiago de Compostela, Spain
    • Hospital Clínico Universitario de Santiago
  • Valencia, Spain
    • Hospital Universitario y Politecnico La Fe
  • Valencia, Spain
    • Hospital Clínico Universitario de Valencia
  • Valladolid, Spain
    • Hospital Clinico Universitario de Valladolid
  • Vigo, Spain
    • Hospital Alvaro Cunqueiro
  • Zaragoza, Spain
    • Hospital Universitario Miguel Servet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Angiolite and abbreviated DAPT; Acute coronary syndrome patients: Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6 months.; No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1M. Only the same P2Y12 inhibitor up to 12M. Chronic coronary syndrome patients: Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.; No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.	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.; Other Names: iVascular angiolite; 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
Experimental: Xience stent family and abbreviated DAPT; Acute coronary syndrome patients: Need for OAC: TAT + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.; No need for OAC: DAPT with acetylsalicylic acid + prasugrel or ticagrelor for 1 month. Only the same P2Y12 inhibitor up to 12M. Chronic coronary syndrome patients: Need for OAC: TAT + clopidogrel + OAC for one week. Double therapy composed of clopidogrel + OAC up to 6M.; No need for OAC: DAPT with acetylsalicylic acid + clopidogrel for one month. Only clopidogrel up to 12M.	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; 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™; Other Names: Xience stent family
Active Comparator: Angiolite and standard of care DAPT; Acute coronary syndrome patients: Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.; No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M. Chronic coronary syndrome: Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.; No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid.	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.; Other Names: iVascular angiolite; 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
Active Comparator: Xience stent family and standard of care DAPT; Acute coronary syndrome patients: Need for OAC: Recommendations of the current ESC guideline: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.; No need for OAC: Recommendations of the current ESC guideline: DAPT with acetylsalicylic acid and prasugrel or ticagrelor is recommended up to 12M. Chronic coronary syndrome: Need for OAC: Recommendations of the current ESC guidelines: 1M of TAT (acetylsalicylic acid + clopidogrel + OAC). Dual therapy (acetylsalicylic acid or clopidogrel + OAC) up to 12M. If ischemic concerns prevail, TAT can be extended up to 6M and dual therapy up to 12M.; No need for OAC: Recommendations of the current ESC guidelines: DAPT composed of acetylsalicylic acid + clopidogrel up to 6M. Then, continue with acetylsalicylic acid.	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; 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™; Other Names: Xience stent family

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the rate of target lesion failure between angiolite stent and Xience stent family (tested for non-inferiority) in both the standard of care DAPT regimen and abbreviated antiplatelet therapy group.	1 year
To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) between an abbreviated DAPT regimen and the standard of care DAPT (tested for superiority of the experimental arm).	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the rate of adverse ischemic events between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy (tested for non-inferiority).	1 year
Rate of target lesion failure between angiolite stent and Xience stent family (Skypoint or Sierra) (tested for non-inferiority) in the standard of care subgroup.	1 year

Other Outcome Measures

Outcome Measure	Time Frame
To determine the rate of Patient-Oriented Composite endpoint	1-2-3-4-5 years
To determine the rate of individual components of All cause, cardiovascular, and cardiac death	1-2-3-4-5 years
To determine the rate of recurrent myocardial infarction	1-2-3-4-5 years
To determine the rate of target lesion revascularization	1-2-3-4-5 years
To determine the rate of target vessel revascularization	1-2-3-4-5 years
To determine the rate of stent thrombosis	1-2-3-4-5 years
To determine the rate of clinical device success	Immediatly after the procedure
To determine the rate of clinical procedural success	Immediatly after the procedure
To determine the rate of bleeding events	1-2-3-4-5 years
To determine the rate of net adverse clinical endpoints (NACE)	1-2-3-4-5 years
To determine the rate of major adverse cardiac and cerebral events (MACCE)	1-2-3-4-5 years
To determine the rate of transfusion rates	1-2-3-4-5 years
To determine the rate of clinically relevant bleeding events (BARC 2, 3, or 5) at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study	1 year
To determine the rate of adverse ischemic events at 1 year between an abbreviated dual antiplatelet therapy regimen and the standard of care dual antiplatelet therapy in the female population of the study	1 year

Collaborators and Investigators

• Sponsor: iVascular S.L.U.
• Investigators: Principal Investigator: Manel Sabaté, Hospital Universitario de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2030

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; dual antiplatelet therapy; angiolite
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine
• Other Study ID Numbers: ANGIODAPT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No