跳至主要内容
临床试验/CTRI/2026/01/100907
CTRI/2026/01/100907尚未招募不适用

Impact of Plaque Eccentricity on Post-Stenting Vessel Geometry Assessed by Intravascular Ultrasound in Patients Undergoing Percutaneous Coronary Intervention

Kasturba Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2026年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
170
试验地点
1
主要终点
Post-stent stent eccentricity index (SEI) at MLA site (continuous).

研究概览

简要总结

Coronary plaque morphology influences stent deployment mechanics. Eccentric plaque, often co localized with calcification, can resist uniform expansion, leading to asymmetric stent geometry and malapposition, both linked to adverse outcomes. IVUS provides high-resolution cross-sectional visualization, enabling quantification of plaque burden, distribution, and luminal/stent geometry. While IVUS-guided PCI improves achievement of larger MSA and reduces adverse events compared with angiography-guided strategies, the specific role of pre-stent plaque eccentricity as a predictor of post stent eccentricity is less well established in prospective real-world Indian cohorts. Some prior studies have reported correlations between calcific arcs, eccentric burden, and under-expansion; however, definitions of eccentricity and thresholds vary, and many analyses are post-hoc or limited by small samples and heterogeneous methodologies. A focused, prospective core-lab study using standardized IVUS definitions and motorized pullbacks can address these gaps. By adjusting for confounders (vessel size, lesion length, calcification severity, stent sizing, and post-dilatation), this study aims to isolate the independent contribution of plaque eccentricity to stent symmetry. The findings could inform lesion preparation (atherectomy or specialty balloons in highly eccentric, calcific plaques), refine stent sizing, and establish pragmatic imaging-based algorithms to target symmetric expansion and adequate MSA.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •Age greater than 18 years .
  • •Undergoing PCI with planned IVUS guidance for a native coronary lesion with eccentric plaque de novo.
  • •Undergoing PCI in ACS Settings with eccentric plaque.
  • •Lesions with analyzable pre-intervention and post-deployment IVUS pullbacks motorized, standardized settings.
  • •Provision of informed consent.

排除标准

  • •In-stent restenosis, bypass graft lesions.
  • •Chronic total occlusions requiring subintimal tracking poor IVUS standardization.
  • •Hemodynamic instability precluding standardized imaging.
  • •Inadequate IVUS image quality severe artefact, loss of EEL visualization on either pre- or post-stent run.

结局指标

主要结局

Post-stent stent eccentricity index (SEI) at MLA site (continuous).

时间窗: At Baseline

次要结局

  • -Minimum stent area (MSA, mm²).(- Stent expansion (% relative to average of proximal & distal reference areas).)

研究者

发起方
Kasturba Medical College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Rachepalli Sandesh Kumar Reddy

Kasturba Medical College Manipal

研究点 (1)

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