A PMCF study to evaluate the safety and efficacy of the Bovine Pericardial Tissue Patch in Vascular Surgeries
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 1.Safety: Incidence of adverse events related to the use of bovine pericardial patch, including
研究概览
简要总结
A PMCF study to evaluate the safety and efficacy of the Bovine Pericardial Tissue Patch in Vascular Surgeries.
Study Design-The study will be single centric, prospective, interventional clinical study.
Primary Objectives:
• Safety: Incidence of adverse events related to the use of bovine pericardial patch, including
infections, thrombosis, and allergic reactions.
• Efficacy: Patency rates of vascular grafts assessed through imaging studies - Doppler ultrasound
at specified follow-up intervals.
• Patch handling and characteristics
Secondary Objectives:
• Patients will be examined post-surgery by evaluating the occurrence of wound infection,
hematoma, partial thrombosis, thrombotic occlusion, pseudoaneurysm, stroke, myocardial
infarction, carotid artery thrombosis, paralysis, restenosis
• Mortality rate.
Subject Types
The study population will consist of subjects in the following group: -
Patients scheduled for vascular surgery requiring a patch graft.
Population and Enrolment
A total of 15 subjects will be recruited for the study of the product Bovine Pericardial Tissue Patch for
vascular surgery.
Inclusion and Exclusion criteria
Inclusion Criteria
• Adults aged 18 years and older undergoing vascular surgery requiring a patch graft.
Exclusion Criteria
• Patients with known allergies to bovine products or pre-existing conditions contraindicating the
use of bovine pericardial patches
• Patients with uncontrolled infections
• Pregnant patients.
Duration of Data collection
The duration of data collection will be 1 year
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 years and older undergoing vascular surgery requiring a patch graft.
排除标准
- •1.Patients with known allergies to bovine products or pre-existing conditions contraindicating the use of bovine pericardial patches.
- •2.Patients with uncontrolled infections 3.Pregnant patients.
结局指标
主要结局
1.Safety: Incidence of adverse events related to the use of bovine pericardial patch, including
时间窗: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term | outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months,6 months and 1 year.
infections, thrombosis, and allergic reactions.
时间窗: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term | outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months,6 months and 1 year.
2.Efficacy: Patency rates of vascular grafts assessed through imaging studies - Doppler ultrasound
时间窗: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term | outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months,6 months and 1 year.
at specified follow-up intervals.
时间窗: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term | outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months,6 months and 1 year.
3.Patch handling and characteristics
时间窗: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term | outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months,6 months and 1 year.
次要结局
- 1.Patients will be examined post-surgery by evaluating the occurrence of wound infection,(hematoma, partial thrombosis, thrombotic occlusion, pseudoaneurysm, stroke, myocardial)
研究者
Dr Robbie K George
Mazumdar Shaw Medical Center- a unit of Narayana Health