Evaluation of Safety and Effectiveness of the SONICO-CX Intracoronary Electrohydraulic Shockwave Balloon Catheter

NCT05732025 | Unknown DMC

• 1 other identifier: SAHZJU CT020
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Calcified coronary lesions often run through various complex lesions, which increases the difficulty of coronary intervention, is one of the main challenges faced by interventional cardiovascular physicians. Severely calcified lesions, or severely calcified lesions with twisted, angulated, diffused, significantly increase rates of immediate complications and early and late major adverse cardiovascular events. Correctly identifying and evaluating calcified lesions, and selecting the most appropriate treatment strategy according to the degree of coronary artery calcification are very important for improving the success rate of intervention, reducing complications, and improving the short-term and long-term prognosis of patients.

Conditions

Calcified Atheroma

Keywords

Calcified coronary lesions; Rotary atherectomy; Electrohydraulic shock wave lithotripsy; Optical coherence tomography (OCT)

Outcome Measures

Primary Outcomes (1)

• Stent expansion rate using OCT

  Stent expansion rate=Minimum lumen area in the stent/(distal reference vessel area + proximal reference vessel area)\*1/2

  Immediately after surgery

Secondary Outcomes (8)

• Angiography success rate

  Immediately after surgery

• Minimum stent area (MSA) immediately after surgery

  Immediately after surgery

• Minimum lumen diameter MLD immediately after operation

  Immediately after surgery

• The diameter of the lumen immediately after operation

  Immediately after surgery

• Obtained lumen area immediately after operation

  Immediately after surgery

Study Arms (2)

Electrohydraulic shock wave lithotripsy

EXPERIMENTAL

Pre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy

Device: Electrohydraulic shock wave lithotripsy

Rotary atherectomy

ACTIVE COMPARATOR

Pre-treatment of severe calcified coronary lesions with Rotary atherectomy

Device: Rotary atherectomy

Interventions

Electrohydraulic shock wave lithotripsy DEVICE

Pre-treatment of severe calcified coronary lesions with electrohydraulic shock wave lithotripsy

Electrohydraulic shock wave lithotripsy

Rotary atherectomy DEVICE

Pre-treatment of severe calcified coronary lesions with rotary atherectomy

Rotary atherectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical Criteria:
• Age ≥ 18 years old
• Evidence of asymptomatic ischemia, stable or unstable angina
• Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to accept angiography, OCT examination and clinical follow-up.
• Angiographic Criteria:
• The target lesion is primary and in situ coronary artery lesion
• The length of the target lesion is ≤60mm, and the diameter of the target lesion is 2.5-4.0mm (visually)
• The stenosis rate of the target lesion diameter is ≥70%, and the doctor judges that it is necessary to implant a stent (visual inspection method) to meet one of the following:
• Diameter stenosis ≥ 70%, \< 100%
• ≥50%, \<70% with evidence of ischemia
• The lesion allows a 0.014 guidewire to pass
• Under multi-angle imaging conditions, calcified shadow lesions can be seen on both sides of the lesion vessel wall (the target lesion meets the definition of severe calcification)

You may not qualify if:

• Clinical Criteria:
• Acute myocardial infarction occurred within 30 days before operation
• Use special balloons (chocolate balloons, scored balloons, spinous balloons, etc.) to treat lesions at the same time
• Troponin is greater than 5 times the upper limit of laboratory normal value within one week before operation
• Severe cardiac dysfunction (grade III or IV)
• Left ventricular ejection fraction \<25%
• The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery
• Severe uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg)
• Severe renal failure (serum creatinine \> 221 μmol/L)
• Preoperative hemoglobin \<100g/L
• Obvious coagulation dysfunction (platelet count\<100×109/L or INR\>1.7, INR is only required for patients who have taken warfarin orally within 2 weeks before enrollment)
• Blood hypercoagulability diseases (such as polycythemia vera, platelet count \>750×109/L, etc.)
• History of stroke or TIA within 3 months
• History of active peptic ulcer or upper gastrointestinal bleeding within 6 months
• The life expectancy of the patient is less than 12 months

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Officials

• Jian-an Wang, MD,PhD

  Second Affiliated Hospital of Zhejiang University, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Jiang, MD,PhD

CONTACT

+86-13588706891; Jiang_jun@zju.edu.cn

Haibo Chen, PhD

CONTACT

+86-13777825345; chenhaibo1030@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 16, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share