Clinical Trial on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy

NCT06521905 | Not Yet Recruiting

• 1 other identifier: intravascular lithotripsy
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

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 controlled trial. Patients with inadequate stent expansion due to calcification detected by intravascular ultrasound(IVUS) 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.

Conditions

Intravascular Lithotripsy

Outcome Measures

Primary Outcomes (1)

• Satisfaction Rate of Stent Expansion[Effcacy]

  Satisfied stent expansion is defined as meeting the standard of good expansion after stent implantation through IVUS after PCI

  immediately after percutaneous coronary intervention(PCI)

Secondary Outcomes (3)

• Major Cardiovascular Events[Effcacy]

  1 year after after percutaneous coronary intervention(PCI)

• Lumen Obtainment after PCI[Effcacy]

  immediately after percutaneous coronary intervention(PCI)

• Incidence of Treatment-Emergent Complications[Safety]

  immediately after percutaneous coronary intervention(PCI)

Study Arms (2)

experimental group

EXPERIMENTAL

intravascular lithotripsy is used on the basis of high-pressure balloon dilation

Device: intravascular lithotripsy

control group

ACTIVE COMPARATOR

only use more positive high-pressure ballon dilation

Device: high-pressure ballon

Interventions

intravascular lithotripsy DEVICE

The intravascular lithotripsy can intermittently release acoustic pressure waves at the site of vascular calcification lesions, thereby achieving the goal of rupturing calcified plaques; After the rupture of calcified plaques, the vascular calcification lesions can be fully dilated with the help of lower balloon inflation pressure.

experimental group

high-pressure ballon DEVICE

High pressure balloon dilation, as the main method for traditional treatment of insufficient stent expansion caused by calcification, has a good therapeutic effect on insufficient stent expansion caused by calcification

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Officials

• Kefei Dou, Doctor

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefei Dou, Doctor

CONTACT

13801032912; drdoukefei@126.com

Bowen Li, bachelor

CONTACT

18003188046; libowen@fuwai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, China National Center for Cardiovascular Diseases

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share