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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT05813704
Brief Summary:
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.
Detailed Description:
This study is divided into two phases. The first phase is the pilot study stage, which is a prospective single-group observational test (FIM phase). The second phase is the pivotal study phase, which is a prospective, multi-center, single-group clinical trial (OPC phase). It is carried out in about 20 hospitals in China.
1. Pilot study phase (FIM phase): It is a prospective single-group observational test. It is expected to recruit 10 subjects in a research center in China.
2. Pivotal study phase (OPC phase): It is a prospective, multicenter, single-group clinical trial. 146 subjects are expected to be recruited in 20 research centers in China.
3. All subjects with coronary chronic total occlusions participating in this clinical study must have only a CTO lesion which occluded in length of more than 5 mm and located in a native coronary artery with a diameter of ≥ 2.50 mm (visual inspection).
4. All subjects receive clinical follow-up during hospitalization, 30 days after surgery.
Study:
NCT05813704
Study Brief:
Protocol Section:
NCT05813704