Status:
NOT_YET_RECRUITING
Clinical Trial on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Intravascular Lithotripsy
Eligibility:
All Genders
18-80 years
Phase:
NA
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 cont...
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 b...
Eligibility Criteria
Inclusion
- Age range: 18-80 years old, male or non pregnant female
- The patient or guardian can voluntarily sign and understand the informed consent form, and can accept follow-up
- Asymptomatic ischemic, stable or unstable angina or myocardial infarction (MI) (including ST segment elevation and non ST segment elevation MI) with chest pain onset to hospital admission time\>24 hours, as well as old myocardial infarction patients
- Visually assess the target lesion with a reference vessel diameter of 2.5-4.0mm, diameter stenosis degree ≥ 70% or ≥ 50%, and evidence of ischemia
- The target lesion is the only lesion that requires treatment this time
- Patients suitable for percutaneous coronary stent implantation
- Confirmed by coronary angiography or IVUS testing that the target lesion is calcified, with any degree of calcification
- After surgical treatment for calcified lesions, IVUS testing confirmed that it meets the criteria for incomplete stent expansion
Exclusion
- Exclusion criteria for patient level:
- Individuals with abnormal coagulation function tests
- Patients with severe hemodynamic disorders
- Clinical manifestations of heart failure with LVEF\<30%
- I have experienced an acute myocardial infarction in the past week
- Patients allergic to heparin, contrast agents, antiplatelet drugs, anticoagulants, anesthetics, etc
- Patients with severe myocardial bridge/negative remodeling or target vessel thrombosis
- Pregnant or lactating women
- Patients with malignant tumors or comorbidities with a life expectancy of less than 12 months
- History of active peptic ulcer or gastrointestinal bleeding within 6 months prior to enrollment
- Stroke occurred within 6 months prior to enrollment, excluding transient ischemic attack (TIA) and cerebral infarction
- Severe liver and kidney function impairment, transaminase levels exceeding the upper limit of normal by more than three times, creatinine levels greater than 2.5mg/dL (221 μ moI/L), or chronic renal failure requiring long-term dialysis
- Anti thrombotic therapy intolerance
- Severe anemia, thrombocytopenia, or leukopenia
- History of severe bleeding (intracranial, gastrointestinal)
- Also participating in other patients who have not completed clinical trials at the same time
- Patients with poor compliance and inability to complete the study on time
- Other situations deemed unsuitable by researchers to participate in this clinical study
- Exclusion criteria for vascular level:
- Thrombotic lesion
- Bridge vascular disease
- Angiography shows tortuous vascular pathways, making it difficult for experimental instruments to reach the target position or retrieve them
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT06521905
Start Date
October 1 2024
End Date
October 1 2026
Last Update
July 29 2024
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