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NCT Number: NCT05952206

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IMELDA, Bonheiden, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Angiolite: Sirolimus-eluting stent

Device

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

Xience: Everolimus-eluting stent

Device

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

1-month DAPT

Drug

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

12-month DAPT (Standard of care)

Drug

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

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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 1 year

Other outcomes

  1. To determine the rate of Patient-Oriented Composite endpoint

    Time frame: 1-2-3-4-5 years

  2. To determine the rate of individual components of All cause, cardiovascular, and cardiac death

    Time frame: 1-2-3-4-5 years

  3. To determine the rate of recurrent myocardial infarction

    Time frame: 1-2-3-4-5 years

  4. To determine the rate of target lesion revascularization

    Time frame: 1-2-3-4-5 years

  5. To determine the rate of target vessel revascularization

    Time frame: 1-2-3-4-5 years

  6. To determine the rate of stent thrombosis

    Time frame: 1-2-3-4-5 years

  7. To determine the rate of clinical device success

    Time frame: Immediatly after the procedure

  8. To determine the rate of clinical procedural success

    Time frame: Immediatly after the procedure

  9. To determine the rate of bleeding events

    Time frame: 1-2-3-4-5 years

  10. To determine the rate of net adverse clinical endpoints (NACE)

    Time frame: 1-2-3-4-5 years

  11. To determine the rate of major adverse cardiac and cerebral events (MACCE)

    Time frame: 1-2-3-4-5 years

  12. To determine the rate of transfusion rates

    Time frame: 1-2-3-4-5 years

  13. 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

    Time frame: 1 year

  14. 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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

iVascular S.L.U.

Industry

Registry information

Official study 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

Acronym: ANGIODAPT

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
Jul 19, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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