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:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT03429894
Brief Summary:
The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter. All patients be followed clinically at 30 days, 6 and 9 months, and 1, 2 and 3 years.
All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months.
Detailed Description:
The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter. All patients be followed clinically at 30 days, 6 and 9 months, and 1, 2 and 3 years.
All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months.
At select centers, a subset of approximately 20 patients will undergo FFR pressure wire measurement at baseline and at follow-up (or at a minimum follow-up) in conjunction with the IVUS imaging, and will also undergo OCT imaging at 9 or 12 months.
The primary safety endpoint is Target Lesion Failure at 6 months. TLF is a composite endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion revascularization.
The primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is the change in mean in-device area and mean lumen area at 9 or 12 months compared to post-procedure as measured by IVUS.
Co-primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is late lumen loss as measured by QCA and IVUS at 9 or 12 months.
Study:
NCT03429894
Study Brief:
Protocol Section:
NCT03429894