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临床试验/CTRI/2019/03/018301
CTRI/2019/03/018301招募中未知

Effectiveness and Safety of Optical Coherence Tomography- Guided PCI in Indian Patients with Complex Lesions- A Multicenter, Prospective Registry

Dr Praveen Chandra0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1. Patients of either sex aged 95 years > 18 years
  • 2. Patients willing to sign the informed consent form
  • 3. Patients scheduled for a clinically indicated PCI procedure, meeting the below criteria:
  • Medically treated diabetes mellitus, AND/OR
  • (i) Angiographically-detected high risk lesions, with at least one target lesion in the planned target vessel, and meeting the below criteria:
  • Target lesion is the culprit lesion responsible for either NSTEMI, or STEMI >24 hours from the onset of ischemic symptoms.
  • (ii)Long or multiple lesions (defined as intended total stent length in any single target vessel H28 mm)
  • (iii)Bifurcation lesion with side branch H2.5 mm by visual estimation, intended to be treated with planned two-stent strategy (stenting in both the main branch and side branch)
  • (iv) Angiographic severe calcification (defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion)
  • (v)In-stent restenosis (all patterns, as long as the lesion is at or within the stent margin(s) and has an angiographically visually-assessed DS H70% or DS H50% with non-invasive or invasive evidence of ischemia)

排除标准

  • 1.Patients unwilling to sign informed consent
  • 2.Patients with bypass graft stenoses
  • 3.Patients with renal insufficiency (estimated glomerular filtration rate <50 mL/min/m2) or any other severe medical condition interfering with patientsâ?? safety or study results
  • 4. Patients with contraindications to dual-antiplatelet therapy up to 1 year
  • 5.Patients with other comorbidities that may limit life expectancy to less than one year

研究者

发起方
Dr Praveen Chandra

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