Safety and Efficacy of the Cutting Balloon to Treat Resistant Pulmonary Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 12
- 主要终点
- Acute Change in Minimum Lumen Diameter Immediately Post-intervention
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of transcatheter Cutting Balloon therapy for branch pulmonary artery stenosis resistant to low pressure dilation.
详细描述
The proposed study will be a prospective, multi-center, randomized, blinded trial comparing 2 treatments for pulmonary artery stenosis. Specifically, vessels that fail to respond to balloon inflation at 8 ATM will be individually randomized to 1 of 2 treatment pathways. In the first treatment pathway, the vessel is dilated using a CB, followed by additional low pressure balloon dilation (< 8ATM). In the second pathway,the vessel is dilated with high pressure balloon angioplasty, with balloon inflation pressures exceeding 15 ATM. Cross-over therapy will be permitted for failed high pressure treatment starting with enrollment of patient #15. The primary outcome assessment for efficacy will be a comparison of percent change in minimum lumen diameter before and after randomized therapy, as determined by a core laboratory blinded to pathway assignment. The primary outcome assessment for safety will be a comparison of the proportion of vessel dilations resulting in any serious adverse events, as determined by the Data and Safety Monitoring Board. Patient-level safety endpoints will also be tabulated. Patients can have multiple vessels enrolled; analytical techniques will adjust for potential intra-patient correlation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria (Determined Prior to Cardiac Catheterization)
- •a. At least 1 branch pulmonary artery stenosis referred for planned catheterization for PA dilation b. At least one of the following: i.greater than one half systemic right ventricular pressure ii. regional decrease in pulmonary blood flow by lung scan iii. elevated pulmonary artery pressures (> 20 mmHg MPAP) iv. cyanosis at least in part due to PA stenosis c. Informed consent of patient and/or parent/guardian; assent of mature minors d. Agreement to participate in protocol, including follow-up testing
- •Vessel Inclusion Criteria (Determined During Cardiac Catheterization)
- •Native pulmonary artery or branch which fails balloon dilation up to 8 ATM; as defined by failure to eliminate a waist
- •Native pulmonary artery or branch with a balloon waist diameter less than 7.5 mm (i.e.,0.5 mm less than the largest available CB) with dilation at 8 ATM
- •All eligible vessels that are dilated during the catheterization must be enrolled as study vessels; "off-study" use of Cutting Balloons or high pressure dilations in eligible vessels is not allowed.
排除标准
- •3. Patient Exclusion Criteria (Determined Prior to Cardiac Catheterization)
- •Prior pulmonary artery angioplasty or surgery on the vessel within the previous 6 weeks
- •Vessel Exclusion Criteria (Determined During Cardiac Catheterization)
- •Vessel with an aneurysm from a prior dilation or surgery, defined as a local enlargement of the vessel greater than 100% of the lumen diameter both proximally and distally to the aneurysm. The maximum aneurysm diameter and vessel lumen diameter proximal and distal to the aneurysm will be recorded. The location of the aneurysm relative to the angioplasty site will be determined and reported as proximal, distal, or in the region of waist formation.
- •Prior stent placement associated with the obstruction
- •i. balloon inflation for the purpose of expanding the diameter of the stent along its length with no residual waist proximal or distal to the stent edges ii. balloon inflation resulting in waist formation within the edges of a stent iii. dilation of a vessel through the cells of a stent c. Unifocalized nor non-unifocalized systemic to pulmonary artery collaterals. d. A vessel requiring therapy at a site not amenable to delivery or safe positioning of a Cutting Balloon device due to unfavorable anatomy as determined by the physician and based on as assessment of vessel angles, size, length, and proximity to other vessels.
研究组 & 干预措施
Patients with Resistant Pulmonary Artery Stenosis
Vessels with resistant PA stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation
干预措施: Transcatheter Cutting Balloon therapy (Device)
Patients with Resistant Pulmonary Artery Stenosis
Vessels with resistant PA stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation
干预措施: High Pressure Balloon Angioplasty (Procedure)
结局指标
主要结局
Acute Change in Minimum Lumen Diameter Immediately Post-intervention
时间窗: Pre-intervention to immediate post-intervention (approximately 10 minutes)
The primary efficacy outcome is the percent change in minimum lumen diameter from pre-intervention to immediately post-intervention as measured by angiography.
次要结局
- Percent Change in Minimum Lumen Diameter at 3 Months Post-intervention(3 months post-intervention)
研究者
Kathy Jenkins
Professor of Pediatrics
Boston Children's Hospital