NCT06669195

Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions

Feasibility and Safety of Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xuzhou Third People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery. Coronary artery calcification not only makes stent delivery and expansion more difficult during PCI, but also increases the risk of vessel perforation. In addition, calcified plaque can lead to incomplete stent expansion, which increases the risk of in-stent restenosis and thrombosis. Although the technology and techniques of interventional devices continue to improve, heavily calcified lesions remain an important risk factor for PCI failure. This study is a prospective, multicenter, randomized study. It is planned to select 40 cases of subjects with calcified plaque can lead to incomplete stent expansion who meet the inclusion/exclusion criteria. They are randomly dividing them into Intravascular lithotripsy treatment group and high-pressure balloon treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, and 12 months after operation. Follow-up with angiography and OCT are conducted at 12 months. The primary endpoint was thickness of neointima at 12 months.

Conditions

• Coronary Artery Disease
• Calcification

Interventions

Type	Name	Description
DEVICE	Intravascular lithotripsy group	20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Intravascular lithotripsy group.
DEVICE	high-pressure balloon group	20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of high-pressure balloon group.

Timeline

• Start date: 2024-12-12
• Primary completion: 2026-12-13
• Completion: 2027-03-13
• First posted: 2024-11-01
• Last updated: 2024-11-01