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.
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。