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

January 20, 2025 updated by: Spectrumedics Medical Technology(Shanghai)Co.,Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
266

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Procedural success rate
Time Frame: During hospitalization (up to 7 days after operation)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Angiography success rate
Time Frame: Immediately after operation
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
Time Frame: Immediately after operation
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
Time Frame: before discharge, 30 days and 6 months post-procedural
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: before discharge, 30 days and 6 months post-procedural
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spectrumedics Medical Technology(Shanghai)Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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