Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521905
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Clinical Trial on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Multicenter Randomized Controlled Study on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our aim is to investigate the efficacy and safety of intravascular lithotripsyIVL 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 ultrasoundIVUS 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 lithotripsyIVL 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 ultrasoundIVUS in the target vessel after percutaneous coronary interventionPCI 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None