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Calcified Coronary LesionsCOCALPNCT06787547

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

A study testing IVL(Sonico-CX) in people with Calcified Coronary Lesions, run by Spectrumedics Medical Technology(Shanghai)Co.,Ltd at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Calcified Coronary Lesions
What is being tested?
IVL(Sonico-CX)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
11 sitesChina
Study dates
1 Dec 2021to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General inclusion 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 informed consent, and are willing to undergo angiography, OCT, and clinical follow-up.
  • Angiographic Inclusion Criteria
  • The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
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  • 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).

Who cannot join

  • General inclusion criteria
  • 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)
Show all 34Show fewer
  • 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
  • The patient has an active systemic infection
  • The patient has a connective tissue disease (such as Marfan's syndrome)
  • The patient is allergic to contrast material
  • Patients undergoing heart transplantation
  • Patients with pacemakers implanted
  • The patient is pregnant or breastfeeding
  • Those who have participated in clinical trials of other drugs or medical devices within 1 month before enrollment
  • 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:
  • Unprotected left main disease (left main visual stenosis > 50%)
  • Baseline TIMI blood flow less than grade 3 (allows evaluation after pre-dilation)
  • A stent has been implanted within 10mm of the proximal or distal end of the target lesion
  • The target lesion is located at the distal end of the saphenous vein or LIMA/RIMA bypass graft
  • Aneurysm within the target blood vessel
  • Angiography confirmed the presence of thrombus in the target vessel
  • Chronic total occlusive lesions
  • Angiography confirmed the presence of severe dissection of the target lesion prior to hydroelectric shock wave lithotripsy treatment (D-F dissection (NHLBI classification)）
  • The investigators determined that the target lesion was unsuitable for patients undergoing vasodilation

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

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

    Guangzhou, Guangdong, 510120

  • The Second Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310009

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310020

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

    Hefei, Anhui, lkma@ustc.edu.cn

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514000

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009

  • Ningbo First Hospital University

    Ningbo, Zhejiang, 315000

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Tongji Hospital, Tongji University

    Shanghai, Shanghai Municipality, 200065

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
IVL(Sonico-CX)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVL(Sonico-CX)Device

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

Study groups in NCT06787547
Study groupRoleWhat they receive
Patients underwent Intravascular lithotripsy (IVL)ExperimentalPatients with severely calcified coronary lesions were enrolled and underwent IVL
Receives: Device: IVL(Sonico-CX)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: During hospitalization (up to 7 days after operation)

Secondary outcomes (3)

  1. 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

    Measured: Immediately after operation

  2. 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

    Measured: Immediately after operation

  3. MACE events

    MACE--a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)

    Measured: before discharge, 30 days and 6 months post-procedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start1 Dec 2021
  3. Primary completion29 Nov 2022
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06787547
Sponsor's protocol ID
2021-120R
Acronym
COCALP
Status last verified
Jan 2025
First submitted
14 Jan 2025
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IVL(Sonico-CX) in people with Calcified Coronary Lesions, run by Spectrumedics Medical Technology(Shanghai)Co.,Ltd at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural success rate (time frame: During hospitalization (up to 7 days after operation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06787547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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