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

NCT06936176 | Recruiting

• 1 other identifier: LFBY-202501
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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
• \*\*Pre-treatment:\*\* Imaging (CT angiography, ultrasound) to confirm eligibility.
• \*\*Procedure:\*\* Shockwave catheter breaks up calcium, followed by stent placement.
• \*\*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

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (2)

• Procedural Success Rate

  Successful stent deployment with residual stenosis \<30% after the procedure (via angiography).

  Immediately post-procedure (intraoperative).

• 30-Day Major Adverse Events (MAE) Rate

  Composite of: All-cause death； Stroke (ischemic or hemorrhagic, with neurological deficits lasting ≥24h)； Myocardial infarction (MI) (per standard diagnostic criteria).

  30 days (±7 days) post-procedure.

Secondary Outcomes (5)

• Device Success

  Intraoperative

• Device Malfunction Rate

  Intraoperative

• Target Lesion Revascularization Rate

  Within 7 days/Before Discharge, 1 Month Postoperative

• Ipsilateral Stroke Rate

  Within 7 days/Before Discharge, 1 Month Postoperative

• Major Adverse Cardio-Cerebrovascular Events (MACCE) Rate

  Within 7 days/Before Discharge, 1 Month Postoperative

Study Arms (1)

Patients with calcified extracranial carotid artery stenosis

EXPERIMENTAL

Study Arm: Single-arm, prospective, multicenter trial evaluating the safety and efficacy of the Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for pretreatment of calcified lesions in the extracranial carotid artery prior to carotid artery stenting (CAS).

Device: Neurovascular Intravascular Shockwave Catheter

Interventions

Neurovascular Intravascular Shockwave Catheter DEVICE

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.

Patients with calcified extracranial carotid artery stenosis

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 18-80 years (inclusive), gender unrestricted.
• Extracranial carotid artery: Preoperative CT angiography (CTA) confirms symptomatic carotid stenosis ≥50% or asymptomatic carotid stenosis ≥70% with calcification (CTA measurement: calcification \> 50% of circumference).
• Note: (Extracranial carotid artery: Internal carotid artery or carotid bifurcation; Symptomatic refers to having had a non-disabling ischemic stroke or TIA within 6 months.)
• Intraoperative digital subtraction angiography (DSA) confirms carotid stenosis ≥50% (by NASCET criteria) or asymptomatic carotid stenosis ≥70% (by NASCET criteria).
• Participants with a pre-enrollment modified Rankin Scale (mRS) score ≤2.
• Participants planned for carotid artery stenting (CAS) who have failed conventional balloon dilation.
• Patients or their legal guardians understand the purpose of the trial, provide informed consent, and agree to follow-up.

You may not qualify if:

• Target lesion caused by non-atherosclerotic disease.
• Participants with complete occlusion of the target lesion or contralateral carotid artery.
• Participants with severe disability due to cerebral infarction.
• Participants with large acute or subacute thrombi near the target lesion, or with arteriovenous malformations or aneurysms.
• Participants with tortuous target lesion vessels that prevent stent placement.
• Participants with symptomatic severe stenosis in other cerebral vessels.
• Participants requiring concurrent or additional surgical interventions during the trial period.
• Participants with tandem severe stenosis or occlusion in vessels proximal or distal to the target lesion.
• Participants who have had a myocardial infarction or large cerebral infarction within 2 weeks prior to screening.
• Participants who have had intracranial hemorrhage within 3 months prior to screening.
• Participants with vulnerable or high-risk plaques (unstable, prone to rupture, and thrombosis leading to acute cardiovascular events or death) as judged by carotid ultrasound.
• Participants with uncontrolled hypertension (systolic blood pressure persistently ≥180 mmHg or diastolic blood pressure persistently ≥110 mmHg).
• Participants with known platelet count \< 90×10\^9/L, severe liver impairment (transaminases \> 3 times the upper limit of normal), severe renal impairment (serum creatinine \> 2.5 mg/dL \[221 µmol/L\]), or New York Heart Association Class IV heart failure.
• Participants with coagulopathy (INR ≥2.0) or contraindications to heparin or antiplatelet agents.
• Participants with active infections.

Sponsors & Collaborators

• Shanghai Bluesail Boyuan Medical Technology Co., Ltd.: lead

Study Sites (1)

Beijing An Zhen Hospital of the Capital University of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 20, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)