Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT02455804
Brief Summary:
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Detailed Description:
The main objective of this study is to collect and analyze additional information about the safety and effectiveness of the NIRxcell Stent System in the treatment of de novo stenotic lesions in native coronary arteries in the US population. The primary endpoint will be the rate of target vessel failure (TVF) at 3 years of treatment with the NIRxcell Stent System. This rate will be compared with a performance goal derived from a meta-analysis of coronary stenting with bare metal stents (BMS).
Study:
NCT02455804
Study Brief:
Protocol Section:
NCT02455804