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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT06521905
Brief Summary:
Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial. Patients with inadequate stent expansion due to calcification detected by intravascular ultrasound(IVUS) were randomly divided into two groups. The experimental group received IVL in addition to high-pressure balloon post-dilation, while the control group only received high-pressure balloon post-dilation. Follow up for 1 year is conducted to determine the safety and efficacy of IVL application based on the primary efficacy endpoint, key secondary efficacy endpoint, other secondary efficacy endpoint, and safety endpoint.
Detailed Description:
In order to investigate the effectiveness and safety of intravascular lithotripsy(IVL) in patients with calcium induced stent insufficiency, we designed a prospective, randomized, controlled, single blind, multicenter, and superior efficacy clinical trial. We include a real-world population of patients who had stent underexpansion due to calcification detected by intravascular ultrasound(IVUS) in the target vessel after percutaneous coronary intervention(PCI) and met the inclusion and exclusion criteria. In addition to routine clinical treatment, IVUS testing was performed on patients after PCI. Patients who met the criteria for stent underexpansion detected by IVUS are randomly divided into two groups. The experimental group received IVL intervention on the basis of high-pressure balloon post-dilation, while the control group received more aggressive high-pressure balloon post-dilation treatment. The satisfaction rate of stent dilation detected by IVUS in both groups after IVL or high-pressure balloon post-dilation was taken as the main efficacy endpoint. MACE events (composed of cardiovascular death, target vessel myocardial infarction and target vascular revascularization) from PCI to one-year follow-up are evaluated. And the acquisition of lumen after treatment is used as other secondary efficacy endpoints. We use postoperative complications such as coronary artery spasm, dissection, acute occlusion, and persistent ventricular arrhythmia as safety endpoints.
Study:
NCT06521905
Study Brief:
Protocol Section:
NCT06521905