NCT07230847Toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 6.
Rövid összefoglaló (regiszter, angolul)
BioFreedom™ is the world's first polymer-free drug-coated stent (DCS), utilizing a proprietary microstructured surface technology. Its abluminal microporous surface directly carries BA9™ (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 BioFreedom™'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 BioFreedom™ DCS or Xience drug-eluting stent system. The findings will provide multidimensional insights into the devices' post-implantation efficacy and safety profiles.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 60 (tervezett)
- Első benyújtás
- 2025. szept. 28.
- Kezdés
- 2025. dec. 10.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- China National Center for Cardiovascular Diseases
- Betegségek
- Koszorúér-betegség
- NCT-szám
- NCT07230847
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 60
- 2025. dec. 10. és az elsődleges befejezés (2026. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines
Más betegség
- Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor
- 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
- Angiographic Exclusion Criteria:
- Left main coronary artery disease
Laborértékek
- 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)
Egyéb
- General Exclusion Criteria:
- Cardiogenic shock patients
- Life expectancy <12 months or factors potentially compromising clinical follow-up
- Bypass graft lesions
- Evidence of extensive thrombus in target vessel
Kiket keres a vizsgálat
- Age ≥18 years
- Male or non-pregnant female
- Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI)
- No contraindications for coronary artery bypass grafting (CABG)
- High bleeding risk (HBR) patients per ARC-HBR definition (meeting ≥1 major or 2 minor criteria):
- Major Criteria:
- Expected long-term oral anticoagulation
- Severe/end-stage chronic kidney disease (eGFR <30 mL/min)
- Moderate/severe anemia (Hb <110 g/L)
- Spontaneous bleeding requiring hospitalization/transfusion within 6 months (or recurrent)
- Chronic bleeding diathesis
- Moderate/severe thrombocytopenia pre-PCI (platelet count <100×10⁹/L)
- Liver cirrhosis with portal hypertension
- Active malignancy in past 12 months (excluding non-melanoma skin cancer; defined as diagnosis/treatment within 12 months)
- History of spontaneous intracranial hemorrhage
- Traumatic intracranial hemorrhage within 12 months
- Known cerebral arteriovenous malformation
- Moderate/severe ischemic stroke within 6 months
- Major surgery/severe trauma within 30 days pre-PCI
- Planned non-deferrable major surgery during dual antiplatelet therapy
- Minor Criteria:
- Age ≥75 years
- Moderate chronic kidney disease (eGFR:30~59 ml/min)
- Mild anemia (male: Hb=110~129 g/L; female: Hb=110~119 g/L)
- Spontaneous bleeding requiring hospitalization/transfusion within 6-12 months pre-PCI
- Chronic NSAID/steroid use post-PCI
- Ischemic stroke >6 months pre-PCI
- Capable of understanding trial objectives and providing informed consent
- Angiographic Inclusion Criteria:
- Target lesion must be primary native coronary artery lesion
- Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence
- ≥1 non-target lesion requiring intervention
- Non-target lesions eligible for elective treatment within 1 month
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Fuwai Hospital ，CAMS&PUMC | Beijing | Kína | Toboroz |
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