The Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter in the Pre-dilation of Coronary Artery Stenosis Lesions

Official title

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Coronary Artery Serrated Cutting Balloon Dilation Catheter for the Predilation of Coronary Artery Stenosis Lesions

Overview

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

• Device Coronary 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.
• Device Cutting balloon catheter
  Ninety-one subjects who met the inclusion criteria were enrolled and randomly assigned to the treatment group using a cutting balloon catheter.

Primary outcome measures

• Device Procedural Success Rate [Time frame: one hour]

Secondary outcome measures (9)

• Clinical treatment success rate [Time frame: one hour]
• acute lumen gain,ALG [Time frame: one hour]
• The incidence of the composite endpoint of target lesion failure (TLF) within 30 days after surgery [Time frame: 30 days]
• The incidence of patient-related cardiovascular clinical composite endpoint (POCE) within 30 days after surgery [Time frame: 30 days]
• The incidence of major adverse cardiac events (MACE) within 30 days after surgery [Time frame: 30 days]
• Evaluation of Device Performance [Time frame: one hour]
• The incidence rate of medical device-related complications [Time frame: one hour]
• The incidence rate of device defects [Time frame: one hour]
• The incidence rate of adverse events and serious adverse events [Time frame: thirty days]

Eligibility criteria

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 Exclusion Criteria

• Patients with New York Heart Association (NYHA) Class IV heart failure.

• Patients with contraindications to anti - platelet and anticoagulant therapy and are unable to receive anticoagulant treatment.

• Patients who have had any myocardial infarction within one week.

• Patients with an allergic reaction to contrast agents. ⑤ Patients with severe renal failure, with a serum creatinine level > 2.0 mg/dl (177 μmol/L).

• Patients who have undergone heart transplantation.

• Patients who have had active peptic ulcer or active gastrointestinal bleeding within 1 month before surgery.

⑧ Patients who have had a stroke or transient ischemic attack within 3 months before surgery.

• Pregnant or lactating patients. ⑩ Patients who are currently participating in any other clinical trials. ⑪ Patients whom the investigator deems unsuitable for enrollment. Exclusion Criteria Related to the Target Lesion (Detected by Coronary Angiography)
• Tortuous lesions or lesions with an angulation of ≥ 45 degrees at the lesion site.

• Lesions at the ostium with a distance of ≤ 2 mm from the left main coronary artery.

• Unprotected left main coronary artery lesions. ④ Coronary angiography shows the presence of thrombus. ⑤ Before using the test device or the control device, the target lesion has a dissection of Type C or higher.

Target lesions that require treatment with coronary atherectomy or special balloons (such as scored balloons, spiked balloons, shock - wave lithotripsy systems, and cutting balloons of other brands).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06926400 · JW-SEBC202412

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗