Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)

A Prospective, Multicenter, Single-Arm Objective Performance Criteria Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for Pretreatment of Calcified Lesions in the Extracranial Carotid Artery (CREATE Trial)） (Extended Follow-Up)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06936189

Enrollment

204

Registered

2025-04-20

Start date

2025-05-12

Completion date

2027-12-30

Last updated

2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Stenosis

Brief summary

Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis. Design: Prospective, multicenter, single-arm study with an extended follow-up period. Sample Size: 204 participants (based on the final number of cases enrolled in the registration trial). Endpoints: Primary: Surgical success rate (residual stenosis \<30% after stenting). Secondary: Target lesion re-narrowing rate, target lesion revascularization rate, MAE rate, ipsilateral stroke rate, and MACCE rate at 3 and 6 months postoperatively. Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively. Inclusion criteria: All patients participating in this extended follow-up period are sourced from the registered clinical trial. Ethics and Consent: The trial will be conducted in accordance with the Helsinki Declaration and Chinese regulations. Informed consent will be obtained from all participants or their legal guardians. Sponsor: Shanghai Lanfan Boyuan Medical Technology Co., Ltd. Principal Investigator: Professor Huo Xiaochuan, Beijing Anzhen Hospital.

Detailed description

\### Detailed Description This clinical trial evaluates the safety and long-term efficacy of a disposable neurovascular intravascular lithotripsy (IVL) catheter and intravascular lithotripsy treatment device for pre-treatment of calcified lesions in the extracranial segment of the carotid artery. The study is designed as a prospective, multicenter, single-arm trial （extended follow-up period）. \#### Study Population: All patients participating in this extended follow-up period are sourced from the registered clinical trial.（The registered clinical trial:Participants aged 18-80 years with symptomatic (≥50%) or asymptomatic (≥70%) calcified carotid artery stenosis confirmed by CT angiography (CTA) and digital subtraction angiography (DSA) are eligible. Patients who have failed conventional balloon dilation and are planned for carotid artery stenting (CAS) will be included.） \#### Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively. Assessments will include clinical evaluations, imaging studies (CT angiography or carotid ultrasound), and recording of adverse events. * Endpoints: * \*\*Primary Endpoint\*\*: Surgical success rate defined as residual stenosis \<30% after stenting. * \*\*Secondary Endpoints\*\*: Target lesion re-narrowing rate, target lesion revascularization rate, MAE (major adverse events) rate, ipsilateral stroke rate, and MACCE (major adverse cardiovascular and cerebrovascular events) rate at 3 and 6 months postoperatively. * Ethical Considerations: Informed consent will be obtained from all participants or their legal guardians. The study will be conducted in accordance with the Helsinki Declaration and local regulatory requirements.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

All patients participating in this extended follow-up period are sourced from the registered clinical trial.

Exclusion criteria

none

Design outcomes

Primary

Measure	Time frame	Description
Target lesion re-narrowing rate	at 3 months and 6 months postoperatively	Proportion of patients with ≥50% diameter stenosis at the target lesion, assessed by imaging at 3 and 6 months.

Secondary

Measure	Time frame	Description
Target lesion revascularization rate	at 3 months and 6 months postoperatively	Incidence of repeat revascularization procedures at the treated lesion, evaluated at 3 and 6 months.
MAE (Major Adverse Events) rate	at 3 months and 6 months postoperatively	Rate of major adverse events (death, myocardial infarction, stroke) within 3 and 6 months.
Ipsilateral stroke rate	at 3 months and 6 months postoperatively	Incidence of stroke on the treated side, confirmed by clinical and imaging studies at 3 and 6 months.
MACCE (Major Adverse Cardio-Cerebrovascular Events) rate	at 3 months and 6 months postoperatively	Composite rate of death, stroke, myocardial infarction, and revascularization at 3 and 6 months.

Countries

China

Contacts

Primary ContactXiaochuan Huo

huoxiaochuan@126.com010-64412431

Outcome results