Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06936176

Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)

Led by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. · Updated on 2025-05-16

204

Participants Needed

1

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

* Clinical Trial Summary * Trial Title:\*\* CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions * Sponsor:\*\* Shanghai Bluesail Boyuan Medical Technology Co., Ltd. * Clinical Trial Leader:\*\* Beijing Anzhen Hospital * Coordinating Investigator:\*\* Prof. Huo Xiaochuan * Study Purpose This trial assesses a new device-a single-use neurovascular intravascular shockwave catheter and therapy device-for treating calcified blockages in the carotid artery. It uses sound waves to break up calcium deposits, facilitating stent placement and blood flow restoration. * Eligibility * Adults aged 18-80 with severe carotid artery narrowing (≥50% symptomatic or ≥70% asymptomatic) due to calcium buildup. * Patients who failed standard balloon dilation. * Exclusions include pregnancy, recent strokes/heart attacks, uncontrolled hypertension, or other high-risk conditions. * Study Design * \*\*Type:\*\* Prospective, multicenter, single-arm trial. * \*\*Sample Size:\*\* 204 patients across multiple hospitals. * \*\*Duration:\*\* 1-month follow-up post-procedure. * Procedures 1. \*\*Pre-treatment:\*\* Imaging (CT angiography, ultrasound) to confirm eligibility. 2. \*\*Procedure:\*\* Shockwave catheter breaks up calcium, followed by stent placement. 3. \*\*Follow-up:\*\* Assessments at 7 days (or discharge) and 1 month post-procedure. * Benefits and Risks * \*\*Benefits:\*\* Improved stent placement success, reduced risk of complications, minimally invasive with shorter recovery time. * \*\*Risks:\*\* Bleeding, infection, vessel damage, stroke, heart attack, device malfunction. Risks are closely monitored with emergency protocols. * Patient Protections * Ethics committee approval and strict safety guidelines. * Voluntary participation with the option to withdraw anytime. * Free treatment and compensation for trial-related injuries. * For Healthcare Providers * \*\*Innovation:\*\* Adapts coronary lithotripsy technology for carotid use. * \*\*Evidence:\*\* Supported by preclinical data and a pilot study (100% success rate in 5 patients). * \*\*Endpoints:\*\* Primary: Stent success (residual stenosis \<30%) and 30-day major adverse events. Secondary: Device success rate, repeat procedures, long-term outcomes. * Contact Information For questions, contact: \*\*Ms. Zhang Yanjiao\*\* Email: yanjiao.zhang@jwmsgrp.com

CONDITIONS

Official Title

Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years, any gender
  • Severe carotid artery narrowing confirmed by CT angiography: symptomatic 50% or asymptomatic 70% with over 50% calcification around the artery
  • Carotid stenosis confirmed by intraoperative angiography: symptomatic 50% or asymptomatic 70%
  • Modified Rankin Scale score of 2 or less before enrollment
  • Planned for carotid artery stenting after failing conventional balloon dilation
  • Ability to understand the trial purpose, provide informed consent, and comply with follow-up
Not Eligible

You will not qualify if you...

  • Blockage caused by non-atherosclerotic disease
  • Complete blockage of the target lesion or opposite carotid artery
  • Severe disability from cerebral infarction
  • Large acute or subacute blood clots near the lesion, arteriovenous malformations, or aneurysms
  • Tortuous vessels preventing stent placement
  • Severe narrowing in other brain vessels
  • Need for additional surgery during the trial
  • Severe narrowing or blockage in vessels near the target lesion
  • Heart attack or large stroke within 2 weeks before screening
  • Brain bleeding within 3 months before screening
  • Unstable or high-risk plaques prone to rupture or clotting
  • Uncontrolled high blood pressure (systolic 180 mmHg or diastolic 110 mmHg)
  • Low platelet count, severe liver or kidney impairment, or advanced heart failure
  • Blood clotting disorder or contraindication to heparin or antiplatelet drugs
  • Active infections
  • Unable to use cerebral protection devices
  • Allergy to device components or contrast agents (except rash)
  • Life expectancy less than 1 year
  • Pregnant or breastfeeding
  • Currently enrolled in another drug or device trial
  • Other conditions the investigator considers unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing An Zhen Hospital of the Capital University of Medical Sciences

Beijing, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial) | DecenTrialz