NCT06385067尚未招募不适用
Prospective, International Multicenter Clinical Study Evaluating the Safety and Efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter (BioAscend) in the Treatment of Primary Coronary Artery Disease in the Real World
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Target lesion failure rate (TLF)
研究概览
简要总结
The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.
The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.
详细描述
Study Design:
- Prospective, international multi-center clinical study;
- It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions;
- In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis.
- Register and collect data using the EDC system;
- Enrollment method: competitive enrollment;
- Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Primary coronary artery stenosis with a vessel diameter of 2.0 mm to 2.75 mm;
- •Patients with residual stenosis of ≤ 30 percent after pretreatment and ≤ type B dissection; Patients who voluntarily participate in and sign the informed consent form, and who are willing to undergo follow-up as required by the protocol.
排除标准
- •Pregnant or lactating females;
- •Patients with cardiogenic shock;
- •Patients with severe congestive heart failure or severe heart failure with NYHA class IV;
- •Patients with severe valvular heart disease;
- •Patients with a life expectancy of less than 24 months or factors that make clinical follow-up difficult;
- •Patients who are considered unsuitable for inclusion by the investigator for other reasons.
- •Those who are known to be allergic to melcrolimus and contrast media.
结局指标
主要结局
Target lesion failure rate (TLF)
时间窗: 12 months after surgery
Target lesion failure rate (TLF) at 12 months after surgery, including cardiogenic death, target vascular myocardial infarction, and clinically symptom-driven target lesion revascularization (CD-TLR)
次要结局
- Incidence of thrombotic events as defined by ARC(From postoperative to before discharge, day 30, month 6, month 12, month 24)
- Interventional success rate(Immediately after operation)
- Major adverse cardiac events (MACEs)(From postoperative to before discharge, day 30, month 6, month 12, month 24)
- Device-related cardiovascular clinical composite endpoint(From postoperative to before discharge, day 30, month 6, month 12, month 24)
- Patient-related cardiovascular clinical composite endpoint(From postoperative to before discharge, day 30, month 6, month 12, month 24)
研究者
相似试验
已完成
不适用
5 Year Observation of Patients With PORTICO ValvesAortic Valve StenosisNCT01802788Abbott Medical Devices1,032
已完成
不适用
A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia RepairHernia, VentralIncisional HerniaNCT02712398C. R. Bard120
已完成
3 期
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial SpondyloarthritisAxial Spondyloarthritisr-axSpaNr-axSpaAnkylosing SpondylitisNCT04436640UCB Biopharma SRL508
已完成
不适用
Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-upPresbyopiaNCT06310252Allotex, Inc.71
招募中
不适用
Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young ChildrenCystic FibrosisNCT04509050Sonya Heltshe210