Coronary Artery Disease
Conditions
Brief summary
To evaluate the effectiveness and safety of the coronary serrated cutting balloon dilation catheter for the pre-dilation of coronary artery stenosis lesions.
Detailed description
This study is a prospective, multicenter, randomized controlled, non-inferiority designed clinical trial. It is planned to enroll a total of 182 eligible subjects from multiple research centers. The subjects will be randomly assigned to the experimental group (n = 91) and the control group (n = 91) in a 1:1 ratio. All subjects will undergo immediate coronary angiography after percutaneous transluminal coronary angioplasty (PTCA) to evaluate the success rate of the device.
Interventions
DEVICECoronary artery sawtooth cutting balloon dilation catheter
Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a coronary artery sawtooth cutting balloon dilation catheter.
DEVICECutting balloon catheter
Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a cutting balloon catheter.
Sponsors
JW Medical Systems Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ① The age is between 18 and 80 years old (including the boundary values), and the subjects are male or non-pregnant female. * Have single or multiple coronary artery lesions and diagnosed ischemic heart disease (for example: stable angina pectoris, unstable angina pectoris, old myocardial infarction or asymptomatic myocardial ischemia). * There are coronary artery stenosis lesions confirmed by coronary angiography, which are suitable for percutaneous coronary intervention. The coronary artery stenosis is ≥ 70% (by visual estimation); or ≥ 50% (by visual estimation) and accompanied by evidence of ischemia, and the TIMI blood flow is ≥ Grade 1. * There are de novo or restenosis lesions in the coronary arteries of autologous or bypass graft vessels, and interventional treatment is required. * The visually estimated reference vessel diameter of the target lesion is 2.0mm - 4.0mm, and the lesion length is ≤ 20mm. * When there are multiple lesions that need to be treated, only one coronary artery lesion is selected as the target lesion, and the non-target lesions must be located on different vascular branches. Be able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and be able to and willing to accept the follow-up as specified in this trial.
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device Procedural Success Rate | one hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute lumen gain,ALG | one hour | Immediate lumen gain is defined as: ALG = the immediate minimum lumen diameter after balloon dilation - the minimum lumen diameter before the operation. |
| The incidence of the composite endpoint of target lesion failure (TLF) within 30 days after surgery | 30 days | — |
| The incidence of patient-related cardiovascular clinical composite endpoint (POCE) within 30 days after surgery | 30 days | — |
| The incidence of major adverse cardiac events (MACE) within 30 days after surgery | 30 days | — |
| Clinical treatment success rate | one hour | — |
| The incidence rate of medical device-related complications | one hour | — |
| The incidence rate of device defects | one hour | — |
| The incidence rate of adverse events and serious adverse events | thirty days | — |
| Evaluation of Device Performance | one hour | CRF |
Contacts
Primary ContactWangYang
Outcome results
None listed