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Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT05952206•iVascular S.L.U.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 95 years

Sex

ALL

Healthy Volunteers

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.

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

Key Dates

Start Date

October 13, 2023

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2030

Last Updated

May 16, 2025

Enrollment

2,312

ESTIMATED participants

Conditions

Coronary Artery Disease

Interventions

Angiolite: Sirolimus-eluting stent

DEVICE

Xience: Everolimus-eluting stent

DEVICE

1-month DAPT

DRUG

12-month DAPT (Standard of care)

DRUG

Contacts

Sara Pich, PhD

CONTACT

+34 936 724 711 spich@ivascular.global

Andrea Mancera

CONTACT

+34645093750 amancera@bcccbarcelona.cat

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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