Coronary Artery DiseaseNCT05342961
Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment
A study testing spinous balloon dilatation catheter (Plastic-Blade) and spinous balloon dilatation catheter(lacrosse NSE) in people with Coronary Artery Disease, run by CCRF Inc., Beijing, China.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd.. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- spinous balloon dilatation catheter (Plastic-Blade) and spinous balloon dilatation catheter(lacrosse NSE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2022to 31 Dec 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 18-75 years
- 2.Stable or unstable angina, or previous myocardial infarction, or Asymptomatic ischemia judged by clinician ,Target vascular diameter: 2.00-4.00mm ,Coronary artery stenosis stenosis ≥ 70% by visual inspection, or ≥ 50% with evidence of ischemia, TIMI blood flow≥ 1,the operator judge that the patient needs spinous balloon to treat.
- 3. Paticipant can understand the study ,voluntarily participate in and sign the informed consent form,and accept scheduled follow-up.
Who cannot join
- Patient related:
- 1.Pregnant and breast-feeding women or intention to be pregnant.
- 2.Subjects with MI within one week, or more than one week after the onset of MI,but TNI or TNT have not returned to normal.
- 3.The spinous balloon failed to pass through the stenosis after small balloon dilation , and the lesion need to be rotary grinded.
- 4. Non-target vessel did not be dealed with successful before dealing with target vessel, or non-target vascular lesion number is more than three.
- 5.Serious heart failure（NYHA IV）
Show all 25Show fewer
- 6.Severe renal failure（Cr>443uMol/L) or patients undergoing hemodialysis.
- 7.Patient with heart transplant.
- 8.Patient with CABG.
- 9.Patients with hemodynamic instability or shock symptoms.
- 10.Life expectancy less than one year.
- 11.Expected to undergo surgery within one month.
- 12.Patients with bleeding tendency, history of active gastrointestinal ulcer, contraindications of antiplatelet or anticoagulant treatment, cannot receive anticoagulant treatment, and patients have hemorrhagic stroke within six months.
- 13.Allergy to heparin and contrast agent.
- 14.The illness of the patient make the treatment and evaluation difficult.
- 15.Those who have participated in other drug or medical device trials have not reached main research endpoint.
- 16.Clinicians estimated that the risk of intervention is very high or the patient should be excluded for other reasons.
- 17.Poor of compliance
- Lesion related:
- 18.Lesions of LAD or with a distance of ≤ 2mm beyond LAD.
- 19.Angiogram showed thrombus.
- 20.CTO,and TIMI blood flow=0,
- 21.Coronary artery spasm
- 22.Lesions of LAD without bypass surgery or collateral circulation protection.
- 23.The doctor considered the patient unfit for the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Spinous Balloon Dilatation Catheter (Plastic-BladeTM) in the Treatment of Coronary Artery Disease
The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd..
Read the detailed description
This study is a prospective, multicenter, randomized, controlled and non inferiority designed clinical trial. A total of 160 subjects with CAD from 8 centers will be randomized 1:1 to each group. All subjects evaluated the immediate lumen acquisition immediately after operation and the MACE of 30 ± 7 days after operation. The primary endpoint is the acquisition of lumen immediately after operation. The effectiveness of balloon was evaluated. The safety of balloon was evaluated by adverse events during operation.Clinical follow-up will be conducted at operation, discharge and 30 ± 7 days after operation. The target lesions included the following : opening lesions, bifurcation lesions, calcification lesions and fibrosis lesions; Diameter stenosis ≥ 70% (visual) with evidence of ischemia; Localized lesions with TIMI ≥ 1; RVD=2.00 and 4.00mm , and the vascular segment is suitable for balloon dilatation in anatomical structure。
- Conditions
- Coronary Artery Disease
- Being tested
- spinous balloon dilatation catheter (Plastic-Blade), spinous balloon dilatation catheter(lacrosse NSE)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinous balloon dilatation catheter (Plastic-Blade)Procedure or surgery
To treat Coronary artery disease
spinous balloon dilatation catheter(lacrosse NSE)Procedure or surgery
To treat Coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| spinous balloon dilatation catheter(Plastic-Blade) | Experimental | Patients with CAD will be treated with spinous balloon dilatation catheter(Plastic-Blade). Receives: Procedure: spinous balloon dilatation catheter (Plastic-Blade) |
| spinous balloon dilatation catheter(lacrosse NSE) | Experimental | Patients with CAD will be treated with spinous balloon dilatation catheter(lacrosse NSE) Receives: Procedure: spinous balloon dilatation catheter(lacrosse NSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate lumen acquisition
The difference of the minimum diameter of the target lesion before and after balloon dilatation in the test or control group measured by QCA.
Measured: during the procedure
Secondary outcomes (8)
Rate of device success
Proportion of patients who meet the success criteria. Success criteria be defined as the residual stenosis of the target lesion is less than 50% after balloon dilatation and the balloon delivery system is successfully withdrawn
Measured: during the procedure
Rate of clinical success
Based on device success, no patient occurred composite endpoint (PoCE) during hospitalization
Measured: from procedure to discharge ( to the 7th day after procedure)
Incidence of related complications
Including acute occlusion, vasospasm, vascular rupture, branch or collateral occlusion, subacute stent thrombosis, intimal tear, dissection, etc.
Measured: 30 days after balloon dilatation
% change of clinically meaningful laboratory tests
Record the change of clinically meaningful laboratory tests
Measured: 30 days after procedure
Number of adverse events
Adverse events occurred during balloon dilatation, after balloon dilatation to 30 ± 7 days after discharge
Measured: 30 days
Number of device related composite endpoint
Including TLF, Cardiac Death, TV-MI and ID-TLR
Measured: 30 days
Number of patient oriented composite endpoint
Including all cause death, MI, TLR, TVR, Revascularization of any coronary arteries and thrombus at the lesion.
Measured: 30 days
Total time of device operation performance
Push capacity, passing capacity and withdrawal capacity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start16 May 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCRF Inc., Beijing, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai 10th People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yawei Xu, MD.,Ph D., Principal investigator, Department of Cardiology, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342961
- Sponsor's protocol ID
- KDL-SUF-2021001
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Spinous Balloon Dilatation Catheter (Plastic-BladeTM) in the Treatment of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05342961
- Acronym / sponsor ID
- KDL-SUF-2021001
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- CCRF Inc., Beijing, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai 10th People's Hospital
- Study start
- 16 May 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Apr 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.
The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter (Plastic-Blade) in coronary vascular diseases, which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter (lacrosse NSE) produced by Goodman Co., Ltd..
Detailed description
This study is a prospective, multicenter, randomized, controlled and non inferiority designed clinical trial. A total of 160 subjects with CAD from 8 centers will be randomized 1:1 to each group. All subjects evaluated the immediate lumen acquisition immediately after operation and the MACE of 30 ± 7 days after operation. The primary endpoint is the acquisition of lumen immediately after operation. The effectiveness of balloon was evaluated. The safety of balloon was evaluated by adverse events during operation.Clinical follow-up will be conducted at operation, discharge and 30 ± 7 days after operation. The target lesions included the following : opening lesions, bifurcation lesions, calcification lesions and fibrosis lesions; Diameter stenosis ≥ 70% (visual) with evidence of ischemia; Localized lesions with TIMI ≥ 1; RVD=2.00 and 4.00mm , and the vascular segment is suitable for balloon dilatation in anatomical structure。
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinous balloon dilatation catheter(Plastic-Blade) | Experimental | Procedure: spinous balloon dilatation catheter (Plastic-Blade)Patients with CAD will be treated with spinous balloon dilatation catheter(Plastic-Blade). |
| spinous balloon dilatation catheter(lacrosse NSE) | Experimental | Procedure: spinous balloon dilatation catheter(lacrosse NSE)Patients with CAD will be treated with spinous balloon dilatation catheter(lacrosse NSE) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. 18-75 years
- 2.Stable or unstable angina, or previous myocardial infarction, or Asymptomatic ischemia judged by clinician ,Target vascular diameter: 2.00-4.00mm ,Coronary artery stenosis stenosis ≥ 70% by visual inspection, or ≥ 50% with evidence of ischemia, TIMI blood flow≥ 1,the operator judge that the patient needs spinous balloon to treat.
- 3. Paticipant can understand the study ,voluntarily participate in and sign the informed consent form,and accept scheduled follow-up.
Key exclusion criteria (25 listed)
- 1.Pregnant and breast-feeding women or intention to be pregnant.
- 2.Subjects with MI within one week, or more than one week after the onset of MI,but TNI or TNT have not returned to normal.
- 3.The spinous balloon failed to pass through the stenosis after small balloon dilation , and the lesion need to be rotary grinded.
- 4. Non-target vessel did not be dealed with successful before dealing with target vessel, or non-target vascular lesion number is more than three.
- 5.Serious heart failure（NYHA IV）
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 |
|---|---|---|
| spinous balloon dilatation catheter (Plastic-Blade)To treat Coronary artery disease | Procedure or surgery | spinous balloon dilatation catheter(Plastic-Blade) |
| spinous balloon dilatation catheter(lacrosse NSE)To treat Coronary artery disease | Procedure or surgery | spinous balloon dilatation catheter(lacrosse NSE) |
Primary outcome
Immediate lumen acquisition
Time frame: during the procedure
The difference of the minimum diameter of the target lesion before and after balloon dilatation in the test or control group measured by QCA.
8 secondary outcomes
Rate of device success
Time frame: during the procedure
Rate of clinical success
Time frame: from procedure to discharge ( to the 7th day after procedure)
Incidence of related complications
Time frame: 30 days after balloon dilatation
% change of clinically meaningful laboratory tests
Time frame: 30 days after procedure
Number of adverse events
Time frame: 30 days
Number of device related composite endpoint
Time frame: 30 days
Number of patient oriented composite endpoint
Time frame: 30 days
Total time of device operation performance
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Yawei Xu, MD.,Ph D. principal investigator
Department of Cardiology, Shanghai Tenth People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing spinous balloon dilatation catheter (Plastic-Blade) and spinous balloon dilatation catheter(lacrosse NSE) in people with Coronary Artery Disease, run by CCRF Inc., Beijing, 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 3 inclusion and 25 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 25 Apr 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 Yi Zhang, M.D. (86-21-66300588, yizshcn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate lumen acquisition (time frame: during 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 25 Apr 2022.