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

NCT06936176 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-05-16

No results posted yet for this study

Summary

* 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: [email protected]

Conditions

  • Carotid Artery Stenosis

Interventions

DEVICE

Neurovascular Intravascular Shockwave Catheter

Device: Neurovascular Intravascular Shockwave Catheter (single-use, rapid-exchange balloon catheter with integrated shockwave emitters). Intravascular Shockwave Therapy Device (IVL-HVG-N01, generates localized shockwaves to fracture calcifications). Procedure: Patients undergo standard CAS preparation with guidewire placement and cerebral protection. If conventional balloon angioplasty fails (residual stenosis \>70%), the IVL catheter is advanced to the target lesion. Shockwave therapy is applied at 6 atm, followed by low-pressure balloon dilation (8 atm) if needed. Subsequent stent deployment is performed per standard practice.

Sponsors & Collaborators

  • Shanghai Bluesail Boyuan Medical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06936176 on ClinicalTrials.gov