NCT00958230已完成不适用
An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery
Tissue Regenix Ltd7 个研究点 分布在 2 个国家目标入组 21 人开始时间: 2009年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 7
- 主要终点
- Maintenance of Arterial Patency
研究概览
简要总结
The study is designed to produce early safety and performance data in a small group of patients requiring repair of a peripheral vascular endarterectomy (incision into an artery feeding the limbs which requires a patch to repair the incision after removal of an atherosclerotic plaque that was stopping usual blood flow to the limbs).
Data is being collected to show the procedure is safe and allows for normal blood flow to be resumed.
Data will be used to facilitate CE Mark submission.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for a remote or open peripheral vascular endarterectomy
- •Lack of suitable autologous material to function as closure patch for the arteriotomy
- •Uncomplicated standard elective endarterectomy procedure (per-operative inclusion criteria)
- •Use of dCell™ Vascular Patch as arteriotomy closure material (per-operative inclusion criteria)
- •Patients between 18 and 80 years old, inclusive
- •Haemoglobin > 9 g/dL and platelet count > 100,000/mm3 prior to Day 1
- •Other haematological and biochemical parameters within a range acceptable for the administration of general anesthesia prior to Day 1
- •Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
- •Duly executed, written, informed consent obtained from patient
排除标准
- •Known serious allergy to contrast agent used for angiography
- •Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
- •If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months
- •Patients receiving a revision of an existing graft
- •Patients demonstrating an active local or systemic infection (WBC > 15,000/mm3)
- •Any condition which in the judgment of the Investigator would preclude adequate evaluation of dCell™ Vascular Patch's safety and performance
- •Patients on vitamin K antagonists
结局指标
主要结局
Maintenance of Arterial Patency
时间窗: 6 months for CE Mark, 24 months Post Market Surveillance
次要结局
- Complication Rate(6 months for CE Mark, 24 months for PMS)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
1 期
A Pilot Study of Dociparstat Sodium (ODSH) in Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT02056782Chimerix12
已完成
早期 1 期
Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT01843634Chimerix10
终止
1 期
Selenium in the Treatment of Complicated Lymphatic MalformationsLymphatic MalformationsNCT01212965Medical College of Wisconsin5
终止
3 期
ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)Hypertension, PulmonaryAnemia, Iron DeficiencyNCT03371173Hannover Medical School22
招募中
1 期
Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid TumorsCDH17-positive Advanced Malignant Solid TumorsNCT06501183Shanghai Pudong Hospital17