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The study of intravascular shock wave therapy device combined with SONICO-CX in the treatment of complex coronary artery diseases

The study of intravascular shock wave therapy device combined with SONICO-CX in the treatment of complex coronary artery diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100577
Enrollment
Unknown
Registered
2025-04-11
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Coronary artery disease

Interventions

Experimental group:Use intravascular shockwave therapy device coupled with SONICO-CX single-use coronary intravascular shockwave catheter

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age >=18 years (2) Evidence of asymptomatic ischemia, stable or unstable angina pectoris (3) Calcified lesions requiring coronary intervention (4) Understand the purpose of the trial, participate voluntarily and be willing to accept clinical follow-up

Exclusion criteria

Exclusion criteria: (1) The patient refuses to undergo emergency CABG (2) Uncontrollable severe hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg) (3) Severe renal failure (serum creatinine >221 µmol/L). (4) Preoperative hemoglobin 1.7) (6) Hypercoagulable blood disorders (e.g., true erythrocytosis, platelet count >750×109/L, etc.) (7) History of stroke or TIA within 3 months (8) Patient's life expectancy is less than 12 months (9) Patient has an active systemic infection (10) The patient has a connective tissue disease (e.g., Marfonte's syndrome) (11) Patient is allergic to contrast material (12) Patients who have received a heart transplant (13) The patient is pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frame
The rate of operation;

Secondary

MeasureTime frame
Instrument success rate;Death and Non-fatal myocardial infarction;

Countries

China

Contacts

Public ContactShufu Chang

Zhongshan Hospital, Fudan University

changshufu@163.com+86 186 1688 1731

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026