Effectiveness and Safety of a Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions(COCALP)

NCT06787547 | Completed

• 1 other identifier: 2021-120R
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 11

Brief Summary

This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.

Conditions

Calcified Coronary Lesions

Outcome Measures

Primary Outcomes (1)

• Procedural success rate

  defined as successful stent implantation with ≤30% in-stent residual stenosis and the absence of in-hospital MACE, including cardiac death, MI, and target vessel revascularization

  During hospitalization (up to 7 days after operation)

Secondary Outcomes (3)

• Angiography success rate

  Immediately after operation

• Device success rate

  Immediately after operation

• MACE events

  before discharge, 30 days and 6 months post-procedural

Other Outcomes (1)

• Adverse Events

  before discharge, 30 days and 6 months post-procedural

Study Arms (1)

Patients underwent Intravascular lithotripsy (IVL)

EXPERIMENTAL

Patients with severely calcified coronary lesions were enrolled and underwent IVL

Device: IVL(Sonico-CX)

Interventions

IVL(Sonico-CX) DEVICE

SONICO-CX® balloon matched 1:1 to the reference vessel diameter, was advanced to the target lesion to pretreat

Patients underwent Intravascular lithotripsy (IVL)

Eligibility Criteria

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

You may qualify if:

• 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 informed consent, and are willing to undergo angiography, OCT, and clinical follow-up.
• The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
• Length of the target lesion ≤60mm, diameter of the target lesion 2.5-4.0mm
• Target lesion diameter stenosis ≥70%, the doctor determines the need for stent implantation
• The lesion allows 0.014 guide wires to pass through
• Under multi-angle contrast conditions, it can be seen that there are calcified angiography lesions on both sides of the lesion blood vessel wall (the target lesion meets the definition of severe calcification).

You may not qualify if:

• Patients who fit any of the following criteria were excluded:
• Acute myocardial infarction occurred within 30 days before procedural
• Simultaneous use of spinning or special balloons (chocolate balloons, scoring balloons, spinous balloons, etc.) to treat the lesion
• Troponin was 5 times greater than the upper limit of laboratory normal within one week before procedural
• Severe cardiac insufficiency (Grade III or IV)
• Left ventricular ejection fraction \< 40%
• The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery.
• Uncontrolled severe hypertension (ystolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg)
• Severe renal failure (serum creatinine \> 221μmol/L)
• Preprocedural hemoglobin \< 100g/L
• Significant 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 prior to enrollment)
• Hypercoagulable blood disorders (e.g. Polycythemia vera, platelet count \>750× 109/L, etc.)
• History of stroke or TIA within 3 months
• History of active digestive ulcer or upper gastrointestinal bleeding within 6 months
• The patients has a life expectancy of less than 12 months

Sponsors & Collaborators

• Spectrumedics Medical Technology(Shanghai)Co.,Ltd: lead

Study Sites (11)

First Affiliated Hospital of University of Science and Technology of China,

Hefei, Anhui, lkma@ustc.edu.cn, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Meizhou People's Hospital

Meizhou, Guangdong, 514000, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

Location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Tongji Hospital, Tongji University

Shanghai, Shanghai Municipality, 200065, China

Location

The Second Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, Zhejiang, 310020, China

Location

Ningbo First Hospital University

Ningbo, Zhejiang, 315000, China

Location

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: January 14, 2025
• First Posted: January 22, 2025
• Study Start: December 1, 2021
• Primary Completion: November 29, 2022
• Study Completion: May 31, 2023
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)