> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/ischemic-and-bleeding-outcomes-after-angiolite-stent-1487b9ab-f284-4ee8-ba65-ad181cf2e1f9 > Record changed: 2026-10-13 # Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy NCT05952206 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) Participants 2,312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) Lead sponsor iVascular S.L.U. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) Start date 2023-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) Number of sites 38 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Acronym** ANGIODAPT Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Short title** Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Official title** 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](https://clinicaltrials.gov/study/NCT05952206) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Dates **Completion date** 2030-01-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **First posted** 2023-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Registry last updated** 2026-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Primary completion date** 2027-01-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Start date** 2023-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Size and sites **Actual participants** 2,312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Participants** 2,312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Number of sites** 38 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Lead sponsor** iVascular S.L.U. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Identifiers **Registry ID** NCT05952206 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **ClinicalTrials.gov ID** NCT05952206 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Study design **Allocation** Randomised **Model** Factorial **Purpose** Treatment **Masking** No masking **Masking description** Masking: \* Open-label for the stent type \* Open-label for the antiplatelet regimen Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Outcomes ### Primary outcomes 1. 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. Timeframe: 1 year 2. 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). Timeframe: 1 year ### Secondary outcomes 1. 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). Timeframe: 1 year 2. 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. Timeframe: 1 year Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 95 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Sites - IMELDABonheiden, Belgium - CHU Marie CurieCharleroi, Belgium - ZOL GENKGenk, Belgium - CHC MontlégiaLiège, Belgium - Hospital de La CitadelleLiège, Belgium - Chu Ambroise PareMons, Belgium - Az DeltaRoeselare, Belgium - Az TurnhoutTurnhout, Belgium - Chu LilleLille, France - Icps MassyMassy, France - Ipcs QuincyQuincy-sous-Sénart, France - Chu ToulouseToulouse, France - Complejo Hospitalario Universitario A CoruñaA Coruña, Spain - Complejo Hospitalario TorrecárdenasAlmería, Spain - Hospital Clínic de BarcelonaBarcelona, Spain - Hospital de La Santa Creu I Sant PauBarcelona, Spain - Hospital Germans Trias I PujolBarcelona, Spain - Hospital Universitario de BellvitgeBarcelona, Spain - Hospital Universitario Vall D'HebrónBarcelona, Spain - Hospital San Pedro de AlcantaraCáceres, Spain - Hospital Universitario Juan Ramón JiménezHuelva, Spain - Hospital Universitario Jerez de La FronteraJerez de la Frontera, Spain - Hospital Universitario de Gran Canaria Doctor NegrínLas Palmas de Gran Canaria, Spain - Hospital Universitario de LeónLeón, Spain - Hospital Universitario 12 de OctubreMadrid, Spain And 13 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952206) ## Related records ### Drugs (2) - [Colchicine](https://trialight.com/data/asset/colchicine-ae804b3e-3263-453f-abb3-ae1e813f2ccf.md) - [Telbivudine](https://trialight.com/data/asset/telbivudine-5718dabe-4058-4559-b924-29d47b6e47ed.md) ### Lead sponsors (1) - [iVascular S.L.U.](https://trialight.com/data/company/ivascular-s-l-u-f43c3345-191f-43e4-9f04-29f103e40abd.md) ### Conditions (1) - [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) Primary condition ### Targets (15) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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