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Comparing Angiolite and Xience Stents with Different Antiplatelet Therapies

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

PHASE3 · iVascular S.L.U. · NCT05952206

This study is testing whether angiolite stents work just as well as Xience stents for people with coronary artery disease, while also seeing if a shorter course of blood-thinning medication can reduce bleeding problems.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment2312 (estimated)
Ages18 Years to 95 Years
SexAll
SponsoriVascular S.L.U. (industry)
Locations39 sites (Aalst and 38 other locations)
Trial IDNCT05952206 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, randomized controlled trial designed to evaluate the effectiveness of angiolite stents compared to Xience stents in patients with coronary artery disease. It will assess the non-inferiority of angiolite stents in preventing target lesion failure and the superiority of abbreviated dual antiplatelet therapy (DAPT) over standard DAPT in reducing bleeding complications. Participants will be followed for 12 months to measure these outcomes. The trial will include a diverse patient population and will be open-label regarding the stent type and antiplatelet regimen.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 95 with significant coronary artery stenosis suitable for stent implantation.

Not a fit: Patients with known intolerances to the medications involved or severe hepatic impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with coronary artery disease, potentially reducing complications and enhancing recovery.

How similar studies have performed: Previous studies have shown promising results with similar stent and antiplatelet therapy comparisons, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Aalst and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Coronary Artery Disease, angiolite, dual antiplatelet therapy, percutaneous coronary intervention

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.