Moderate to Severe Calcified Coronary Artery StenosisNCT05552131
Clinical Trial of T-wave™ Coronary Lithotripsy Catheter System
A study testing T-wave coronary lithotripsy catheter system in people with Moderate to Severe Calcified Coronary Artery Stenosis, run by Suzhou Zhonghui Medical Technology Co., Ltd..
Trial summary
A prospective, multi-center, single-group target value method was used in this study. According to the inclusion criteria stipulated in this trial protocol, > 3 medical device clinical trial institutions with the record of the State Food and Drug Administration were selected as clinical centers, and 190 cases were… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Calcified Coronary Artery Stenosis
- What is being tested?
- T-wave coronary lithotripsy catheter system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 30 May 2024
- 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
- Age ≥18 years old;
- Subjects had primary coronary artery disease suitable for percutaneous coronary intervention (including stable or unstable angina pectoris and asymptomatic myocardial ischemia)
- marker of myocardial injury： 3.1 For patients with unstable ischemic heart disease, the biomarker (CK-MB) must be within the normal range within 12 hours before surgery； 3.2 In patients with stable ischemic heart disease, biomarkers can be tested before or during surgery, and (CK-MB) must be within the normal range within 12 hours before or during surgery；
- Patients were able to understand the content of the trial, volunteered to sign the informed consent, were willing to comply with the trial protocol, and had the ability to visit and check regularly;
- Image inclusion criteria:
- No stent has been implanted in the target lesion within 1 year, and no drug-eluting stent has been implanted within 5mm of the target lesion;
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- Single new stenosis of the left main artery of the target vessel, or of the anterior descending branch, right crown or circumflex branch (or its branches), with the following characteristics:
- Visual stenosis ≥70% and <100%; or
- Visual stenosis ≥50% but <70%, combined with evidence of clinical ischemia, such as typical clinical symptoms or positive tablet test results, or fractional flow reserve FFR≤0.80, or instantaneous waveform free ratio instantaneous wave-free ratio<0.90;
- Moderate to severe calcification in the target lesion site is defined as:
- Angiography: Calcification can be detected in at least one location on either side of the arterial wall when the heart is beating or not under fluoroscopy before contrast medium injection; or
- Calcification ≥180° was present in at least one section by intravascular ultrasound.
- The reference diameter of target vessels was between 2.5mm and 4.0mm;
- Length of target lesion ≥5mm but ≤40mm;
- Target vessels must have thrombolysis in myocardial infarction grade 3 before registration (can be evaluated after pre-dilation)
- 0.014 inch guide wire can pass through the lesion;
Who cannot join
- Basic condition (Cardiac function)
- Left ventricular ejection fraction (LVEF) <40%;
- New York Classification of Cardiac Function (NYHA) Class IV; Anatomical structure
- There is a second lesion with an interval of more than 10mm and a stenosis degree of ≥50% in the same target vessel;
- Target vessels were too circuitous, defined as the presence of two or more bends >90º or three or more bends >75º;
- Definite or probable thrombus in the target vessel;
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- Evidence of aneurysm in the target vessel within 10mm of the target lesion;
- The target lesion is located in the primary vessel that can only be reached by saphenous vein or arterial graft bypass;
- There were restriction-limiting dissection with NHLBI (National Heart, Lung, and Blood Institute)grade ≥D in the target vessels before registration.
- Chronic occlusive disease (CTO) : CTO exists in other main vessels outside the target vessel (anterior descending branch, circumflex branch, right crown) or CTO exists in any location of the target vessel.
- Target lesions need to be pretreated with special balloons such as rotary grinding and spinous process balloon; Laboratory tests
- uncontrolled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure > 120 mmHg);
- Acute myocardial infarction (MI) within the past 1 month, and/or signs of active myocardial ischemia at enrollment, including elevated troponin-I or T (with elevated CK), ischemic ECG changes, or chest pain;
- Severe impairment of liver and kidney function, aminotransferase more than 3 times the upper limit of normal, creatinine > 2.5 mg/dL (221 μmol/L) or chronic renal failure requiring long-term dialysis; Note: In subjects with proven or suspected acute MI (as determined by the primary and secondary investigators), markers of myocardial injury must be evaluated prior to enrollment.
- Medical history and Others
- 14. History of stroke or transient ischemic attack (TIA) within 30 days;
- Patients with active peptic ulcer or upper gastrointestinal bleeding within 30 days;
- Had undergone percutaneous coronary intervention within 14 days;
- Patients who were scheduled to undergo a cardiovascular intervention within 30 days after this procedure;
- Patients refuse or are not candidates for emergency coronary artery bypass grafting (CABG) surgery;
- Drug-eluting stents have been implanted in target vessels within the past year;
- Patients with known allergies or contraindications to the raw materials or drugs of the test products (such as antiplatelet drugs, anticoagulants, contrast agents);
- Participating in other clinical trials;
- The patient's expected survival was less than 1 year;
- Women planning to have children during pregnancy, breastfeeding or clinical trials;
- Factors that other researchers believe cannot be included
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Single-group, Target-value Clinical Trial to Evaluate the Safety and Efficacy of Coronary Lithotripsy Catheter System for Lumen Preconditioning in Moderate-to-severe Coronary Artery Calcification
A prospective, multi-center, single-group target value method was used in this study. According to the inclusion criteria stipulated in this trial protocol, > 3 medical device clinical trial institutions with the record of the State Food and Drug Administration were selected as clinical centers, and 190 cases were selected (the first case of each center was taken as the imported case. Follow-up was carried out according to the program process, but the results were analyzed separately. Moderate-to-severe calcified stenosis patients who met all the inclusion criteria and did not meet any exclusion criteria were enrolled into the study. Lumen pretreatment was performed using the coronary shock catheter system and drug-eluting stents were implanted.
Subjects were followed up immediately after surgery, before discharge, 30±3 days after surgery, and 6 months ±14 days after surgery to evaluate the safety and effectiveness of coronary lithotripsy catheter system for preconditioning patients with moderate and severe coronary artery calcification stenosis.
Read more
In this study, the success rate of postoperative surgery was used as the primary endpoint, and major cardiovascular and cerebrovascular adverse events within 30 days after surgery were used as the secondary endpoint.
After the completion of the primary endpoint evaluation of the project, it shall be submitted together with other data to the competent department of medical device approval for initial registration. At the same time, continue to complete the follow-up of the subjects.
- Being tested
- T-wave coronary lithotripsy catheter system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-wave coronary lithotripsy catheter systemDevice
Subjects who plan to receive possible interventional therapy meet all admission criteria and do not meet any exclusion criteria, and enter the screening stage of this clinical trial after signing informed consent. All subjects who sign the informed consent will be provided with a unique subject screening number. All subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled and lumen pretreated with a coronary shock catheter system followed by the implantation of drug-eluting stents.
| Study group | Role | What they receive |
|---|---|---|
| Coronary lithotripsy catheter system + drug-eluting stent | Experimental | Not described Receives: Device: T-wave coronary lithotripsy catheter system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of operation
After the successful passage of the experimental medical device, the residual stenosis rate of the target lesion immediately after the implantation of the drug-eluting stent was less than 50% and no MACE(Major Adverse Cardiovascular Events) occurred in the hospital after the use of the coronary shock catheter system for lumen preparation.
Measured: Immediately after the procedure
Secondary outcomes (12)
Success rate of contrast
After successful passage of the experimental medical instruments, residual stenosis of the target lesion was < 50% after preconditioning and there were no serious angiographic complications, including flow limiting dissection (NHLBI grade D-F type)(NHLBI:National Heart, Lung, and Blood Institute) perforation, acute lumen occlusion, and persistent slow flow or no reflow.
Measured: Immediately after using the test control advice in treatment
Operation success rate 2
After lumen preparation using experimental medical instruments, residual stenosis rate of target lesion after drug eluting stent implantation was less than 50%, blood flow grading was TIMI level 3, and no MACE event occurred during hospitalization.
Measured: Immediately after using the test control advice in treatment
Residual stenosis rate of target lesions after pretreatment with experimental medical instruments
Measured: Immediately after the procedure
Residual stenosis rate of target lesions immediately after operation
Measured: Immediately after the procedure
Thrombolysis In Myocardial Infarction blood flow grading of target lesions immediately after operation
Measured: Immediately after the procedure
Major adverse cardiovascular events (MACE) event rate
Measured: Immediately after the procedure、30days、180days
Major adverse cardiovascular and cerebrovascular events (MACCE) event rate
Measured: Immediately after the procedure、30days、180days
Myocardial infarction rate
Measured: Immediately after the procedure、30days、180days
Rate of revascularization
Measured: Immediately after the procedure、30days、180days
Stent thrombosis rate
Measured: Immediately after the procedure、30days
Lumen diameter was obtained immediately after operation
Measured: Immediately after the procedure
Luminal area obtained immediately after operation
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start20 Dec 2022 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Calcified Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Zhonghui Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552131
- Sponsor's protocol ID
- CSP-T-01
- Status last verified
- Dec 2022
- First submitted
- 15 Sep 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-group, Target-value Clinical Trial to Evaluate the Safety and Efficacy of Coronary Lithotripsy Catheter System for Lumen Preconditioning in Moderate-to-severe Coronary Artery Calcification
- ClinicalTrials.gov ID
- NCT05552131
- Acronym / sponsor ID
- CSP-T-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Suzhou Zhonghui Medical Technology Co., Ltd.University, hospital or other
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi-center, single-group target value method was used in this study. According to the inclusion criteria stipulated in this trial protocol, > 3 medical device clinical trial institutions with the record of the State Food and Drug Administration were selected as clinical centers, and 190 cases were selected (the first case of each center was taken as the imported case. Follow-up was carried out according to the program process, but the results were analyzed separately. Moderate-to-severe calcified stenosis patients who met all the inclusion criteria and did not meet any exclusion criteria were enrolled into the study. Lumen pretreatment was performed using the coronary shock catheter system and drug-eluting stents were implanted.
Subjects were followed up immediately after surgery, before discharge, 30±3 days after surgery, and 6 months ±14 days after surgery to evaluate the safety and effectiveness of coronary lithotripsy catheter system for preconditioning patients with moderate and severe coronary artery calcification stenosis.
In this study, the success rate of postoperative surgery was used as the primary endpoint, and major cardiovascular and cerebrovascular adverse events within 30 days after surgery were used as the secondary endpoint.
After the completion of the primary endpoint evaluation of the project, it shall be submitted together with other data to the competent department of medical device approval for initial registration. At the same time, continue to complete the follow-up of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary lithotripsy catheter system + drug-eluting stent | Experimental | Device: T-wave coronary lithotripsy catheter system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥18 years old;
- Subjects had primary coronary artery disease suitable for percutaneous coronary intervention (including stable or unstable angina pectoris and asymptomatic myocardial ischemia)
- marker of myocardial injury： 3.1 For patients with unstable ischemic heart disease, the biomarker (CK-MB) must be within the normal range within 12 hours before surgery； 3.2 In patients with stable ischemic heart disease, biomarkers can be tested before or during surgery, and (CK-MB) must be within the normal range within 12 hours before or during surgery；
- Patients were able to understand the content of the trial, volunteered to sign the informed consent, were willing to comply with the trial protocol, and had the ability to visit and check regularly;
- No stent has been implanted in the target lesion within 1 year, and no drug-eluting stent has been implanted within 5mm of the target lesion;
Key exclusion criteria (26 listed)
- Basic condition (Cardiac function)
- Left ventricular ejection fraction (LVEF) <40%;
- New York Classification of Cardiac Function (NYHA) Class IV; Anatomical structure
- There is a second lesion with an interval of more than 10mm and a stenosis degree of ≥50% in the same target vessel;
- Target vessels were too circuitous, defined as the presence of two or more bends >90º or three or more bends >75º;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-wave coronary lithotripsy catheter systemSubjects who plan to receive possible interventional therapy meet all admission criteria and do not meet any exclusion criteria, and enter the screening stage of this clinical trial after signing informed consent. All subjects who sign the informed consent will be provided with a unique subject screening number. All subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled and lumen pretreated with a coronary shock catheter system followed by the implantation of drug-eluting stents. | Device | Coronary lithotripsy catheter system + drug-eluting stent |
Primary outcome
Success rate of operation
Time frame: Immediately after the procedure
After the successful passage of the experimental medical device, the residual stenosis rate of the target lesion immediately after the implantation of the drug-eluting stent was less than 50% and no MACE(Major Adverse Cardiovascular Events) occurred in the hospital after the use of the coronary shock catheter system for lumen preparation.
12 secondary outcomes
Success rate of contrast
Time frame: Immediately after using the test control advice in treatment
Operation success rate 2
Time frame: Immediately after using the test control advice in treatment
Residual stenosis rate of target lesions after pretreatment with experimental medical instruments
Time frame: Immediately after the procedure
Residual stenosis rate of target lesions immediately after operation
Time frame: Immediately after the procedure
Thrombolysis In Myocardial Infarction blood flow grading of target lesions immediately after operation
Time frame: Immediately after the procedure
Major adverse cardiovascular events (MACE) event rate
Time frame: Immediately after the procedure、30days、180days
Major adverse cardiovascular and cerebrovascular events (MACCE) event rate
Time frame: Immediately after the procedure、30days、180days
Myocardial infarction rate
Time frame: Immediately after the procedure、30days、180days
Rate of revascularization
Time frame: Immediately after the procedure、30days、180days
Stent thrombosis rate
Time frame: Immediately after the procedure、30days
Lumen diameter was obtained immediately after operation
Time frame: Immediately after the procedure
Luminal area obtained immediately after operation
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing T-wave coronary lithotripsy catheter system in people with Moderate to Severe Calcified Coronary Artery Stenosis, run by Suzhou Zhonghui Medical Technology Co., Ltd..
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 16 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cassie Wu (18800263183, cassie.wu@hh-healthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of operation (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2022.