Clareo Health | A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography
A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography
* Spontaneous bleeding requiring hospitalization/transfusion within 6-12 months pre-PCI
* Chronic NSAID/steroid use post-PCI
* Ischemic stroke \>6 months pre-PCI
6. Capable of understanding trial objectives and providing informed consent
1. Target lesion must be primary native coronary artery lesion
2. Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence
3. ≥1 non-target lesion requiring intervention
4. Non-target lesions eligible for elective treatment within 1 month
You may not be if
1. Presence of ≥1 evidence of heart failure including:
* NYHA Class III or higher, or
* Killip classification ≥ Grade 2, or
* Left ventricular ejection fraction (LVEF) ≤30% within 30 days pre-procedure (by echocardiography or intraoperative ventriculography)
2. Cardiogenic shock patients
3. Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor
4. Life expectancy \<12 months or factors potentially compromising clinical follow-up
5. Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines
6. History of substance abuse (alcohol/cocaine/heroin, etc.)
7. Severe arrhythmias (e.g., high-risk ventricular premature contractions/ ventricular tachycardia)
8. Other medical conditions deemed unsuitable by investigators
1. Left main coronary artery disease
2. Bypass graft lesions
3. Evidence of extensive thrombus in target vessel
