Clinical trial NCT06291545: Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Coronary Stenosis Lesions
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Design Clinical Trial, To Evaluate the Efficacy and Safety of the Coronary Artery Notched Balloon Dilation Catheter for the Pre-dilation of Coronary Artery Stenosis Lesions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: JW Medical Systems Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery.

Detailed description: This trial uses a prospective, multicenter, randomized controlled, non-inferiority comparison design. It is expected that the test group will be non-inferior to the control group in the main effectiveness evaluation index (device success rate). This trial plans to enroll 200 subjects who meet the requirements, and they will be randomly assigned to the test group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up for 30 days after percutaneous coronary intervention (PCI) treatment to compare the test group and the control group in the main effectiveness evaluation index (device success rate), secondary effectiveness evaluation indices (immediate lumen gain \[QCA analysis\], surgical success rate, in-hospital major adverse cardiac event \[MACE\] incidence rate, target lesion failure \[TLF\] incidence rate within 30 days after surgery, patient-related composite endpoints \[PoCE\] incidence rate during and within 30 days after surgery, device operation and performance evaluation), and safety evaluation indices (device-related complication incidence rate, adverse event/serious adverse event incidence rate, device defect incidence rate), in order to evaluate the effectiveness and safety of the coronary scoring balloon dilation catheter of the test medical device.

Eligibility criteria: Inclusion Criteria:

* 1. Voluntary participation in this trial and signed the informed consent form;
* 2. Age: ≥18 and ≤80 years old, regardless of gender;
* 3. The existence of coronary artery stenosis lesions accompanied by evidence of ischemia in the heart (such as symptomatic coronary heart disease, stable/unstable angina pectoris or asymptomatic myocardial ischemia), suitable for percutaneous interventional therapy.

Exclusion Criteria:

* 1. Acute myocardial infarction (AMI) within 7 days before surgery;
* 2. Serum creatinine level \>2.0 mg/dL (177 umol/L) within 7 days before surgery;
* 3. Active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery;
* 4. Stroke or transient ischemic attack (TIA) within 3 months before surgery;
* 5. Known left ventricular ejection fraction (LVEF) \<30% (if LVEF is unknown, it can be measured during this surgery);
* 6. Known allergies to aspirin or heparin or the existence of contraindications that prevent the subjects from receiving sufficient preoperative medications;
* 7. Known subjects allergic to ingredients in the test product or contrast agent;
* 8. Known subjects who are pregnant or breastfeeding;
* 9. Planned to use coronary atherectomy, laser ablation, other scoring / spiked / cutting balloons (non-study devices) or shock wave balloons to treat the target lesion at the same time;
* 10. Subjects participating in other drug or device clinical studies;
* 11. Other situations that are not suitable for participation in this study as assessed by the investigator.

Primary outcomes:
measure: Rate of successful device usage
timeFrame: 1hour
Secondary outcomes:
measure: Rate of success of the surgery
timeFrame: 3 days
measure: Incidence of in-hospital MACE
timeFrame: 30 days
measure: Incidence of PoCE within 30 days after surgery
timeFrame: 30 days
measure: The lumen is obtained immediately
timeFrame: 1hour
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Air Force Medical University
name: Ling Tao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: