Optimisation du Positionnement Des Stents Dans Les lésions Aorto-ostiales : étude Multicentrique Historico-prospective Avec Phase randomisée Comparant l'Angioplastie Coronaire Avec ou Sans Technique du Floating Ballon Étude OSTIAL (Optimizing Stent In Aorto-Ostial Lesion)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- The number of participants in whom stent placement was technically successful and who were evaluated by CT scan.
研究概览
简要总结
Aorto-ostial coronary lesions present a significant challenge during coronary angioplasty. This is due to the difficulty of precisely identifying the aorto-ostial plane and the frequent instability of the guiding catheter during stent deployment.
Despite the angiographic appearance being deemed optimal, several studies have shown a high rate of suboptimal stent positioning at the ostium when subsequent coronary CT angiography (CCTA) assessment is performed.
This suboptimal positioning may be linked to incomplete ostial coverage, which could increase the risk of in-stent restenosis. It may also be linked to excessive stent protrusion into the aorta, which could compromise future procedures, particularly in the context of transcatheter aortic valve replacement.
The "Floating Balloon" (FB) technique has been developed to improve system stability and to reliably mark the aorto-ostial landing zone (AOLZ). A previous study demonstrated the feasibility and accuracy of this technique.
The aim of the current study is to assess the clinical effectiveness of the Floating Balloon. Although this technique is already in use, no study has yet conducted a systematic assessment of stent positioning using CCTA.
The study utilised a combined retrospective-prospective approach to comprehensively evaluate the incidence of suboptimal stent positioning associated with the Floating Balloon technique. This evaluation was conducted by systematically comparing patient outcomes between those treated with the FB and those treated without the FB. The study employed CCTA as a key tool to assess stent position, ensuring a precise analysis of the data.
To achieve this, it is recommended that follow-up data from patients who have already undergone the FB procedure and had their stent position assessed via CCTA (retrospective component) be analysed, while also enrolling new patients and randomizing them into FB and non-FB groups (prospective component).
详细描述
In order to address the primary objective (namely, to estimate the rate of stent malpositioning), 97 evaluable subjects are required to achieve a precision (half-width of the 95% confidence interval) of +/-10% (assuming a conservative 50% rate of correct positioning).
As assessments are conducted immediately after the procedure, the investigators do not anticipate a significant number of non-evaluable subjects. The proposal is to enrol N=100 subjects in the FB group, with 50 subjects in the retrospective phase and another 50 in the prospective phase.
In order to address the secondary objective of comparing malpositioning rates between the two groups (with and without FB), patients in the non-FB group should be enrolled at a 1:2 ratio. The justification for this number is based on feasibility. This will provide preliminary data for the non-FB group.
Therefore, given our retrospective cohort of 50 FB subjects with available measurements, the prospective phase will include N=50 + 25-or 75 additional subjects (50 in the FB arm and 25 in the non-FB arm). The analyses will therefore cover a total of 125 subjects (100 with FB and 25 without FB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Male or female aged over 18 years
- •Prospective part: Patient who has signed an informed consent form
- •Retrospective part: No objection to the use of personal data for this research
- •Indication for coronary angioplasty for an aorto-ostial lesion (right coronary artery or left main coronary artery) for patients included in the prospective part / Patients in the historical part who underwent coronary angioplasty for an aorto-ostial lesion (right coronary artery or left main coronary artery) using the "floating balloon" (FB) technique, followed by a CCTA assessment of positioning
- •Affiliation with or beneficiary of a social security scheme.
排除标准
- •Contraindication to coronary CT angiography (severe renal impairment not requiring dialysis (GFR ≤ 30 ml/min)), applicable only to patients included in the prospective part
- •Refusal of consent (patients included in the prospective part)
- •Objection to the use of personal data (patients in the retrospective part)
- •Patient unable to read, write, or understand French
- •Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP)
- •Adult patient placed under guardianship, curatorship, or judicial protection
- •Patient unable to personally provide consent pursuant to Article L.1121-8 of the CSP, or an adult under legal protection
- •Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP
研究组 & 干预措施
Coronary angioplasty without the floating-balloon technique
干预措施: Coronary angioplasty without the floating-balloon technique (Procedure)
Coronary angioplasty using the floating balloon technique
干预措施: Coronary angioplasty using the floating balloon technique (Procedure)
结局指标
主要结局
The number of participants in whom stent placement was technically successful and who were evaluated by CT scan.
时间窗: At the end of the procedure
Patients who have undergone stent placement will be evaluated using post-procedural CCTA (coronary CT angiography).
时间窗: At the end of the procedure
次要结局
- The secondary outcome is the rate of major adverse cardiovascular events (MACE).(12 months after the surgery procedure)