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临床试验/NCT01981304
NCT01981304Unknown不适用

Effects of a rapamycIn-eluting carboNized Stent With a Completely biodEgradable polymeR Coating on inflammaTory Biomarkers and Endothelial Damage

University of Roma La Sapienza0 个研究点目标入组 50 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Post-PCI changes in markers of inflammation and endothelial damage

研究概览

简要总结

Percutaneous coronary intervention with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to the occurrence of major adverse cardiac events (MACE), such as restenosis, atherosclerosis, and stent thrombosis.

Drugs, platforms and polymers are considered the protagonists of these pathophysiologic processes.

The objectives of the INERT study is to assess the extent of inflammation and endothelial damage induced by the first carbonized bio-absorbable coated rapamycin-eluting coronary stent at time of percutaneous coronary intervention and correlate the extent of these abnormalities with short and long-term clinical outcome and post-procedural evaluation of success.

As part of the study, a randomized sub-study will be carried out at the Coordinating Center in order to compare the biohumoral, clinical and procedural findings between patients with the carbonized bio-absorbable coated rapamycin-eluting coronary stent and those randomly assigned to receive stents with different platforms and polymers.

详细描述

Percutaneous coronary intervention with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to the occurrence of major adverse cardiac events (MACE), such as restenosis, atherosclerosis, and stent thrombosis.

Drugs, platforms and polymers are considered the protagonists of these pathophysiologic processes.

Platforms Due to advances in stent technology, several stent platforms are now available, including the stainless steel, the cobalt-chromium, and the platinum-chromium stent series. Pre-clinical animal studies suggest that some platforms might have important advantages in terms of vascular compatibility and early and late healing. In a rabbit denudation model, it was shown that at 14 days the luminal surface area is incompletely endothelialised with the CrCo stents but nearly complete for other metals. Additionally, it has been shown that a thinner-strut stent is associated with reduced fibrin deposition and more rapid fibrin clearance in porcine coronary arteries compared with thicker stents, thus suggesting that the thin stent platforms may induce less injury. As a matter of fact, The second-generation DESs, with thinner struts, are obviously associated with a suppression of the neointimal response and a more rapid re-endothelialization but stainless steel based stent design might have a better conformability to the vessel wall which results to less malposition.

Polymers The polymer coating that elutes the antiproliferative drug has been linked to complications including delayed vessel healing, hypersensitivity reactions, atheroma, and restenosis, with the potential for repeat intervention, stent thrombosis, acute myocardial infarction, and sudden death.

The link between the permanent polymer and late adverse events has prompted the development of a variety of biodegradable polymer coatings. Absorption of the polymer may lower the rates of stent thrombosis, particularly beyond 1 year after stent implantation. In addition, stents with absorbable polymers may allow a shorter duration of dual antiplatelet therapy (DAPT) than currently recommended The incidence of late adverse events is likely to be lower after the absorption of the polymer than after the implantation of drug-eluting stents coated with a permanent polymer, as there is less ongoing inflammation than with permanent polymers. In a meta-analysis of randomized trials, metal stents that release an antiproliferative drug from an absorbable polymer coating had lower rates of MACE out to 4 years than metal stents that released a drug from a durable polymer. The randomized LEADERS (Limus Eluted from A Durable versus ERodable Stent) trial studies showed that a biolimus eluting stent coated with a biodegradable polymer had a lower risk of adverse cardiac events associated with very late ST through 5 years of follow-up, improving the long-term clinical outcomes compared with sirolimus-eluting stents coated with a durable polymer

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm) Class I indication to elective percutaneous coronary intervention Stable conditions and no recent acute coronary syndromes Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I) Able to understand and willing to sign the informed CF

排除标准

  • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

结局指标

主要结局

Post-PCI changes in markers of inflammation and endothelial damage

时间窗: Baseline and 4 months after PCI

Changes 4 months after PCI in indexes of endothelial damage (von Willebrand Factor, sE-selectin, Vascular cell adhesion molecule, Intercellular adhesion molecule) and inflammation (C-reactive protein, Fibrinogen, Plasminogen activator inhibitor, Interleukin-6)

次要结局

  • 12-month rate of MACE(Up to 12 months)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pelliccia

Assistant Professor

University of Roma La Sapienza

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