Post-market, Prospective Evaluation of PHOTO-oxidized Decellularized Bovine Pericardium Used as a Patch in Vascular Repair and Reconstruction Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 17
- 主要终点
- Incidence of Central Neurologic Events
研究概览
简要总结
The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.
详细描述
PhotoFix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques. The primary endpoint for patients with carotid artery stenosis (CAS) undergoing carotid endarterectomies (CEA) will be rate of ipsilateral central neurologic events; the primary endpoint for all other vascular procedures will be primary patency. The secondary endpoints include all-cause reoperation rate, device-related reoperation rate, explant rate, restenosis rate, secondary patency (hemodialysis access repair (HAR) only) and survival. A goal of 100 patients will be enrolled at approximately 10 sites. The enrollment period will span a minimum of 8 months from Institutional Review Board (IRB) approval and site activation. Candidates for this study are adults who require vascular repair or reconstruction surgery that necessitates the use of a patch. Patients will be consented pre-operatively and enrolled patients will be followed for approximately 6 months after PhotoFix surgery. Data will be collected at 5 time points: baseline (pre-operatively), intra-operatively, 1 month post-operatively, 3 months post-operatively, and 6 months post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient is undergoing a vascular procedure which falls within the indications for use and requires the use of PhotoFix Decellularized Bovine Pericardium
- •Patient's surgery is anticipated to occur within 60 days of consent
- •Patient is ≥18 years old
- •Patient is willing and able to comply with the protocol and follow up period
- •Patient is willing and able to give written informed consent
排除标准
- •Patient's procedure is a revision of a prior arteriotomy or venotomy
- •Patient's procedure requires multiple vascular patches in anatomically distinct regions or other prosthetics (e.g. stents)
- •Patient has a medical history of abnormal coagulopathy, bleeding, or thromboembolic disease
- •Patient has a medical history of severe immunodeficiency disease
- •Patient has a medical history of cancer
- •Patient has severe visceral disease in heart or active liver disease or icterus
- •Patient has a history of cerebrovascular accident (completed stroke) within 3 months of planned surgery
- •Patient has a history of atrial fibrillation and requires a patch for carotid endarterectomy repair
- •Patient has an active or potential infection at the surgical site
- •Patient has used or plans to use immunomodulatory drugs for ≥ 6 months
- •Patient has a sensitivity to products of bovine origin
- •Patient is currently enrolled in another study
- •Patient has a life expectancy of less than 12 months
- •Patient is pregnant or breastfeeding or planning on becoming pregnant or unwilling to use medically acceptable methods of birth control
- •Patient's procedure is emergent
结局指标
主要结局
Incidence of Central Neurologic Events
时间窗: Up to 6 months, post-op
For cases of carotid endarterectomy (CEA) only: Percent of patients who experienced at least one of the central neurologic events of interest (transient ischemic attack, amaurosis fugax, stroke, carotid occlusion).
Primary Patency
时间窗: Up to 6 months, post-op
For all other procedures (non-CEAs): Loss of patency includes loss of previously palpable pulses, presentation of recurrent symptoms, a drop in ABI\>0.15 in the case of lower limb artery repair, Doppler ultrasound findings of occlusion, angiography of the affected vessel or a combination of these. Loss of patency will also be considered if an intervention to restore or maintain patency is documented.
次要结局
- Explant Rate(Up to 6 months, post-op)
- All-Cause Re-operation Rate(Up to 6 months, post-op)
- Adverse Event Rate(Up to 6 months, post-op)
- Device-Related Re-operation Rate(Up to 6 months, post-op)
- Secondary Patency(Up to 6 months, post-op)
- Overall Survival(Up to 6 months, post-op)
- Restenosis Rate(Up to 6 months, post-op)