Abstract：
The anatomical complexity of a chronic total occlusion (CTO) correlates with procedural failure and complication rates. CTO modification after unsuccessful crossing has been associated with subsequent higher technical success rates, but complication rates remain high with this approach. While successful CTO percutaneous coronary intervention (PCI) has been associated with improved angina and quality of life (QOL) this has not been demonstrated in anatomically high-risk CTOs. Whether a planned CTO modification procedure, hereafter named Investment procedure, could improve patient outcomes has never been investigated.
Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8-12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported.
This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.
Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8-12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported.
This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.
摘要：
背景：慢性完全闭塞（CTO）的解剖复杂性与手术失败和并发症发生率相关。交叉失败后的CTO修改与随后的更高技术成功率相关，但这种方法的并发症发生率仍然很高。尽管成功的CTO经皮冠状动脉介入治疗（PCI）与改善的心绞痛和生活质量（QOL）相关，但在解剖学上高风险的CTO中尚未得到证实。是否有计划的CTO修改程序，以下称为投资程序，可以改善患者预后从未被研究过。
方法：投资CTO是一个潜在的，单臂,国际,多中心研究，评估计划投资程序的有效性和安全性，随后完成CTOPCI（8-12周），在解剖学上高风险的CTO中。我们将在挪威和英国的中心根据我们的投资CTO标准招募200名被定义为高风险的CTO患者。主动脉口病变患者，先前支架内的阻塞，或在6个月内之前尝试过目标血管CTOPCI将被排除.共同主要终点是两个程序后的累积程序成功率(%)，和完成CTOPCI后30天的复合安全终点。患者报告结果（PRO），治疗满意度,和临床终点将被报告。
结论：本研究将前瞻性评估计划的两阶段PCI手术治疗高危CTO的有效性和安全性，并可能改变目前的临床实践。
方法：投资CTO是一个潜在的，单臂,国际,多中心研究，评估计划投资程序的有效性和安全性，随后完成CTOPCI（8-12周），在解剖学上高风险的CTO中。我们将在挪威和英国的中心根据我们的投资CTO标准招募200名被定义为高风险的CTO患者。主动脉口病变患者，先前支架内的阻塞，或在6个月内之前尝试过目标血管CTOPCI将被排除.共同主要终点是两个程序后的累积程序成功率(%)，和完成CTOPCI后30天的复合安全终点。患者报告结果（PRO），治疗满意度,和临床终点将被报告。
结论：本研究将前瞻性评估计划的两阶段PCI手术治疗高危CTO的有效性和安全性，并可能改变目前的临床实践。
