Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons Computed-Tomography Fractional Flow Reserve Sub-Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Difference in CT-μFR
研究概览
简要总结
This study investigates changes in coronary artery anatomy and physiology after treatment with a paclitaxel drug-coated balloon (DCB) during percutaneous coronary intervention (PCI). Unlike conventional stenting, DCB treatment delivers an antiproliferative drug to the vessel wall without leaving a permanent metallic implant. The absence of a permanent implant allows non-invasive assessment of the treated coronary artery during follow-up using coronary CT angiography (CCTA).
Participants will undergo two CCTA examinations: an early scan within two weeks after PCI and a follow-up scan after nine months. CT-derived fractional flow reserve (CT-μFR) will be calculated from both scans to assess changes in μFR of the treated coronary artery over time. CCTA will also be used to evaluate changes in coronary plaque and vessel characteristics.
The primary objective is to determine whether CT-μFR changes between early and nine-month follow-up after DCB-PCI. Secondary objectives include evaluating changes in plaque and vessel characteristics on CCTA and assessing clinical outcomes during follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Presence of a de novo lesion;
- •Successful DCB-PCI of a native coronary artery or major side branch.
排除标准
- •No Protégé DCB was used;
- •Previous CABG;
- •Ineligibility for CCTA acquisition due to:
- •Known renal insufficiency, i.e. eGFR ≤ 30 mL/min/1.73m²;
- •Known hypersensitivity or contraindication to CT contrast agents;
- •Body weight > 150 kg.
- •Metallic implants in or around the target vessel;
- •Pregnancy or pregnancy status unknown;
- •Presence of a comorbid condition with a life expectancy of less than one year;
- •Inability to provide informed consent
结局指标
主要结局
Difference in CT-μFR
时间窗: From baseline to 9 month follow-up.
The change in non-invasive CT-μFR between post-procedure and 9-month follow-up within the treated coronary segment treated with DCB.
次要结局
- Late lumen loss (LLL)(From baseline to 9 month follow-up.)
- Change in Minimal Lumen Area (MLA)(From baseline to 9 month follow-up.)
- Change in Plaque Burden (PB)(From baseline to 9 month follow-up.)
- Clinical outcomes(From baseline to 5 years follow-up.)
- Correlations between CCTA-derived measurements(From baseline to 9 month follow-up.)
研究者
Bimmer Claessen
Interventional Cardiologist, Department of Cardiology
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)