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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT06657833
Brief Summary:
International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).
Detailed Description:
Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.
Study:
NCT06657833
Study Brief:
Protocol Section:
NCT06657833