Status:
NOT_YET_RECRUITING
Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide®
Lead Sponsor:
Shanghai Shenqi Medical Technology Co., Ltd
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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 nat...
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 cath...
Eligibility Criteria
Inclusion
- 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-2. 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；
- Reference vessel diameter between 2.0 mm and 2.75 mm；
- Non-target vascular lesions need to be treated with interventional therapy first (must be treated at the same time), after successful treatment, random and target lesions will be treated;
- Preoperative diameter stenosis must be ≥70% or ≥50% with ischemia; (visual inspection)
- Each target lesion can only be treated with one experimental drug balloon;
Exclusion
- 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;
- Coronary artery spasm without significant stenosis;
- The researchers think that the subjects are not suitable for others inclusion reason;
- Evidence of extensive thrombus in the target vessel before intervention;
- Coronary artery bypass grafting using vein grafts;
- Complete occlusion of the target vessel (TIMI grade 0 blood flow before operation)
- Target vessels are distorted or have calcified lesions that cannot be pre-dilated successfully;
- Lesions within 5 mm from the coronary artery ostia;
- Lesions that cannot be treated with PTCA or other interventional techniques;
- After pre-dilation of the target lesion, residual stenosis \> 50% or TIMI blood flow \< grade 3, and/or type C or above dissection;
- Subjects with bleeding constitution, contraindicated anticoagulant or antiplatelet drugs;
- Subjects who cannot tolerate aspirin and/or clopidogrel or have a history of neutropenia or thrombocytopenia, or severe liver insufficiency that prohibits clopidogrel;
- Subjects who are known to be intolerant or allergic to heparin, contrast medium, paclitaxel, iopromide, polylactic acid-glycolic acid polymer, stainless steel, etc.;
- Leukopenia (white blood cell count \<3×109/L for more than 3 days) or neutropenia (ANC\<1000 neutrophils/mm3 for more than 3 days) or history of thrombocytopenia (\<100,000 platelets/mm3) subjects;
- Subjects with a history of peptic ulcer or gastrointestinal bleeding in the past 6 months;
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT06024525
Start Date
January 1 2024
End Date
June 1 2026
Last Update
September 6 2023
Active Locations (1)
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1
Meizhou People's Hospital (Huangtang Hospital, Meizhou Academy of Medical Sciences)
Meizhou, Guangdong, China