AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Post-Marketing Clinical Study of High-Pressure Cutting Balloon

RecruitingNAAges 18 Years - anyAllBrosMed Medical Co., Ltd
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years; * Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation; * Moderate-to-severe calcified lesions on coronary angiography; * Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment; * Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion; * In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be located in different vessel branches; furthermore, the non-target lesion must be treated first, and the target lesion may be treated only after successful revascularization of the non-target lesion without severe angiographic complications; * Provision of written informed consent. Exclusion Criteria: * Life expectancy \<1 year; * Cardiogenic shock or hemodynamic instability; * Left main coronary artery disease; * Chronic total occlusion; * Bifurcation lesions planned for a "two-stent strategy"; * Active bleeding; * Known history of allergy to contrast media or metals; * Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy; * New-onset stroke/transient ischemic attack within 6 months; * Pregnant or lactating women; * Left ventricular ejection fraction \<25%, or NYHA functional class IV, or Killip class โ‰ฅ2; * Non-target vessel revascularization within 30 days before randomization with complications.
๐Ÿ’Š

What it tests

  • High pressure cutting balloon
  • Non-cutting balloon
๐Ÿ“

Where

1 site
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy