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

A Prospective, Multi-center, Single-arm, Objective Performance Goal Pre-specified Study to Evaluate the Safety and Effectiveness of Intravascular Lithotripsy Generator Combined with SONICO-CX Coronary Intravascular Lithotripsy (IVL) Catheter for Pre-treatment of Coronary Calcification Before Stent Implantation

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.

Study Overview

• Status: Completed
• Conditions: Calcified Coronary Lesions
• Intervention / Treatment: Device: IVL(Sonico-CX)

Detailed Description

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). 266 subjects at 11 sites will be enrolled.Subjects will be followed through discharge, 30 days, 6months.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, lkma@ustc.edu.cn
      • First Affiliated Hospital of University of Science and Technology of China,
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
    • Meizhou, Guangdong, China, 514000
      • Meizhou People's Hospital
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Affiliated Hospital of Zunyi Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital, Southeast University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University
    • Shanghai, Shanghai, China, 200065
      • Tongji Hospital, Tongji University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital, Zhejiang University
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital, Zhejiang University
    • Ningbo, Zhejiang, China, 315000
      • Ningbo First Hospital University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• General inclusion criteria

  1. Age ≥ 18 years old
  2. Evidence of asymptomatic ischemia, stable or unstable angina
  3. 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.

• Angiographic Inclusion Criteria

  1. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  2. Length of the target lesion ≤60mm, diameter of the target lesion 2.5-4.0mm
  3. Target lesion diameter stenosis ≥70%, the doctor determines the need for stent implantation
  4. The lesion allows 0.014 guide wires to pass through
  5. 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).

Exclusion Criteria:

• General inclusion criteria

Patients who fit any of the following criteria were excluded:

1. Acute myocardial infarction occurred within 30 days before procedural
2. Simultaneous use of spinning or special balloons (chocolate balloons, scoring balloons, spinous balloons, etc.) to treat the lesion
3. Troponin was 5 times greater than the upper limit of laboratory normal within one week before procedural
4. Severe cardiac insufficiency (Grade III or IV)
5. Left ventricular ejection fraction < 40%
6. The patient refuses emergency CABG surgery or does not have indications for emergency CABG surgery.
7. Uncontrolled severe hypertension (ystolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg)
8. Severe renal failure (serum creatinine > 221μmol/L)
9. Preprocedural hemoglobin < 100g/L
10. 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)
11. Hypercoagulable blood disorders (e.g. Polycythemia vera, platelet count >750× 109/L, etc.)
12. History of stroke or TIA within 3 months
13. History of active digestive ulcer or upper gastrointestinal bleeding within 6 months
14. The patients has a life expectancy of less than 12 months
15. The patient has an active systemic infection
16. The patient has a connective tissue disease (such as Marfan's syndrome)
17. The patient is allergic to contrast material
18. Patients undergoing heart transplantation
19. Patients with pacemakers implanted
20. The patient is pregnant or breastfeeding
21. Those who have participated in clinical trials of other drugs or medical devices within 1 month before enrollment
22. Other circumstances that the investigator deems inappropriate to participate in the trial - Angiographic Exclusion Criteria

Patients who met any of the following criteria were excluded:

1. Unprotected left main disease (left main visual stenosis > 50%)
2. Baseline TIMI blood flow less than grade 3 (allows evaluation after pre-dilation)
3. A stent has been implanted within 10mm of the proximal or distal end of the target lesion
4. The target lesion is located at the distal end of the saphenous vein or LIMA/RIMA bypass graft
5. Aneurysm within the target blood vessel
6. Angiography confirmed the presence of thrombus in the target vessel
7. Chronic total occlusive lesions
8. Angiography confirmed the presence of severe dissection of the target lesion prior to hydroelectric shock wave lithotripsy treatment (D-F dissection (NHLBI classification)）
9. The investigators determined that the target lesion was unsuitable for patients undergoing vasodilation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients underwent Intravascular lithotripsy (IVL); Patients with severely calcified coronary lesions were enrolled and underwent IVL	Device: IVL(Sonico-CX); SONICO-CX® balloon matched 1:1 to the reference vessel diameter, was advanced to the target lesion to pretreat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiography success rate	Angiographic success was defined as successful stent implantation with ≤30% in-stent residual stenosis and without serious angiographic complications immediately after IVL, including type D to F severe dissection, perforation, acute occlusion, sustained slow-flow, or no-reflow	Immediately after operation
Device success rate	Device success was defined as the IVL catheter successfully crossing the target lesion and delivering lithotripsy without serious angiographic complications immediately following the procedure	Immediately after operation
MACE events	MACE--a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)	before discharge, 30 days and 6 months post-procedural

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence of other adverse events during procedural, before discharge, 30 days and 6 months post-procedural	before discharge, 30 days and 6 months post-procedural

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2021-120R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No