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
- 9
- 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
研究组 & 干预措施
Treatment
All patients will undergo a vascular repair or reconstruction surgery, which requires the use of PhotoFix. The surgical procedures will vary by patient and by underlying etiology. Therefore, PhotoFix implant sites will also vary. In all cases, PhotoFix will be implanted per the Instructions for Use (IFU).
干预措施: PhotoFix (Device)
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)