A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantati… (NCT07230847) | Clinical Trial Compass
RecruitingNot Applicable
A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedomâ„¢ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography
China60 participantsStarted 2025-12-10
Plain-language summary
BioFreedomâ„¢ is the world's first polymer-free drug-coated stent (DCS), utilizing a proprietary microstructured surface technology. Its abluminal microporous surface directly carries BA9â„¢ (a sirolimus derivative) with high lipophilicity. This design mitigates inflammatory responses while promoting early vascular healing and reducing thrombotic risk. Extensive clinical evidence has validated BioFreedomâ„¢'s superior performance in high-bleeding-risk (HBR) populations. However, comprehensive assessments of neointimal coverage and quantitative neointimal transformation post-implantation remain insufficient. With advancements in ultra-high-resolution optical coherence tomography (OCT), detailed evaluation of coronary stent healing has become feasible. This study will employ OCT to comparatively assess vascular healing patterns-including neointimal transformation and strut coverage-in ACS patients with HBR receiving either the commercially available BioFreedomâ„¢ DCS or Xience drug-eluting stent system. The findings will provide multidimensional insights into the devices' post-implantation efficacy and safety profiles.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor
✕. Life expectancy \<12 months or factors potentially compromising clinical follow-up
✕. Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines
✕. History of substance abuse (alcohol/cocaine/heroin, etc.)
✕. Severe arrhythmias (e.g., high-risk ventricular premature contractions/ ventricular tachycardia)
✕. Other medical conditions deemed unsuitable by investigators