Prospective, Multi-center Non-inferiority and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- In-segment diameter stenosis in target lesion(%).
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this study is to assess the safety and efficacy of the Paclitaxel-Coated Coronary Balloon Catheters Swide® (3µg/mm2 balloon surface area) in the treatment of Chinese patients with native coronary heart disease and small vessel lesions（reference diameters from 2.0mm to 2.75 mm） in comparison with Paclitaxel-Releasing Coronary Balloon Catheter SeQuent® please Neo
Detailed Description
This study conducted a prospective, multi-center, randomized controlled, non-inferiority clinical trial to compare the safety and efficacy of the Shenqi Medical paclitaxel-coated coronary balloon catheter and the paclitaxel-eluting coronary balloon catheter (SeQuent® please Neo) in the treatment of coronary artery small vascular disease. * A total of 236 participants are planned to be recruited, and they will be allocated into the experimental group and the control group in a 1:1 ratio. * All participants will undergo clinical follow-up at 1 month, 6 months, 9 months, 1 year, and 2 years after receiving the drug-eluting balloon angioplasty procedure. * Angiographic re-evaluation will be conducted for all participants at 9 months after the procedure. The primary study endpoint will be the in-segment diameter stenosis in target lesion(%) at 9 months postoperatively.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Related to the patients:
- •Age ≥18 and ≤80 years old；
- •Subjects with stable angina, or with unstable angina, or with subacute, old myocardial infarction, or evidence of asymptomatic ischemia；
- •Subjects with left ventricular ejection fraction ≥ 30%;
- •During the study, women of childbearing age should not become pregnant or plan to become pregnant. Therefore, it is recommended that subjects use adequate contraceptive measures until (including) the end of the follow-up period；
- •Subjects should have sufficient compliance and agree to receive follow-ups in month-1, 6, 9 and 12, and follow-up visit in year-
- •It is required to perform angiography in 9 month；
- •Subjects should volunteer to participate in this study, and sign the written informed consent form, and understand all risks and benefits in the informed consent document.
- •Related to the diseases:
- •The target lesion is primary, in situ coronary artery lesion, located on 1 or 2 different coronary vessels, and the number of target lesions on each coronary vessel does not exceed 1；
Exclusion Criteria
- •Subjects with myocardial infarction within one week, or subjects whose troponin has not returned to normal despite the onset of myocardial infarction for more than one week;
- •Subjects with severe congestive heart failure or NYHA IV heart failure;
- •Women who are pregnant or breastfeeding;
- •Subjects whose life expectancy does not exceed 1 year or who have factors that make clinical follow-up difficult;
- •Subjects with stroke within 6 months;
- •Subjects who are participating in any other clinical trials and have not reached the primary clinical endpoint;
- •Existing or history of severe liver failure, therefore not eligible for angiography;
- •Existing or history of severe renal failure (GFR\<30ml/min), therefore not eligible for angiography;
- •Heart transplant;
- •Cardiogenic shock;
Outcomes
Primary Outcomes
In-segment diameter stenosis in target lesion(%).
Time Frame: 9 months
DS% = (1 - minimum luminal diameter within the target lesion segment / reference diameter within the target lesion segment) × 100%.
Secondary Outcomes
- Late Lumen Loss(9 months)
- Technical success rate(Immediate postoperative)
- Lesion success rate(Immediate postoperative)
- Procedural success rate(during the hospitalization and no more 7 days)
- The proportion of subjects with patient-related composite endpoints(in month-1, 6, 9, 12 ,24)
- The proportion of subjects with target lesion failure.(in month-1, 6, 9, 12 ,24)
- Proportion of Subjects' mortality(in month-1, 6, 9, 12 ,24)
- Proportion of Subjects' myocardial infarction(in month-1, 6, 9, 12 ,24)
- Proportion of Subjects' target lesion revascularization(in month-1, 6, 9, 12 ,24)
- Proportion of Subjects' any coronary revascularization(in month-1, 6, 9, 12 ,24)
- Proportion of Subjects with Thrombotic Events as defined by ARC(in month-1, 6, 9, 12 ,24)
- Incidence Rate of All AE and SAE in subjects(in month-1, 6, 9, 12 ,24)
- Incidence of target lesion restenosis(9 months)