Post-Marketing Clinical Study of High-Pressure Cutting Balloon
Condition(s) studied
Investigational drug(s) / intervention(s)
High pressure cutting balloon: Lesion preparation is carried out using the cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.
Non-cutting balloon: Lesion preparation is carried out using the non-cutting balloon, and following completion of preparation, all stents are deployed at nominal pressure.
Study summary
This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation. Subjects will be randomized in a 1:1 ratio to the experimental group (n=140) or the control group (n=140). The primary endpoint is the MSA measured by IVUS immediately after the procedure, with the purpose of verifying the safety and efficacy of the high-pressure cutting balloon in optimizing stent implantation outcomes.
Eligibility
Primary outcome measure(s)
- Minimum stent area (MSA) at the site of maximum calcification immediately after stent implantation — procedure day (0 day)
IVUS-measured results obtained after stent implantation and prior to balloon post-dilation
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | Recruiting |
More BrosMed Medical Co., Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07835178 on ClinicalTrials.gov ↗ ← All trials in China