Prospective, Multi-center, Non-Randomized Controlled Trial of Vascular Closure Using the AbsorbaSeal 6 French Vascular Closure Device
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- ID3 Medical
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Treatment success
研究概览
简要总结
This study investigates the efficacy and safety of the AbsorbaSeal 6Fr Vascular Closure device (VCD) for the closure of access site of patients requiring percutaneous diagnostic or interventional procedures. An expected total of 50 patients will be enrolled in this study. A total of 12 patients (4 patients per site) will be treated as roll-in phase, prior to enrollment of the first patient. The primary objective of this study is to assess the safety and effectiveness of the AbsorbaSeal 6Fr VCD. Enrollment into this study will include anatomically eligible patients requiring diagnostic and interventional procedures. Following physician training, patients will be enrolled. Efficacy and safety analyses will be based on these patients.Patients will be followed procedurally to discharge, at one month, (follow-up commitment). Secondary objectives are to further characterize adverse events (serious and non-serious), clinical utility measures and health-related quality of life.
详细描述
With the increased number of percutaneous interventions being performed in outpatient settings there is a growing need to obtain faster, safer, and more secure hemostasis following these outpatient procedures. CyndRx believes an improved VCD will lead to more widespread use and ultimately improve patient outcomes. The AbsorbaSeal Vascular Closure Device (ABS-6) has been developed to meet this need. The ease of use and automatic deployment of the device will eliminate the learning curve associated with the use of VCDs. The active closure system used in the ABS-6 ensures a secure closure with every deployment. The composition of the seal used is completely bio-absorbable and does not require the use of adjunct materials (i.e. collagen, sutures, staples, etc.) needed in many of the devices currently available.
The First In Man (FIM) trial demonstrated the safety and efficacy of the ABS-6 system in humans (N=20). To further evaluate the safety and efficacy, up to 50 patients will be enrolled in the CP002CE-study.
The primary objective of this study is to assess the safety and effectiveness of the AbsorbaSeal 6Fr VCD. Enrollment into this study will include anatomically eligible patients requiring diagnostic and interventional procedures. Patients will be followed procedurally to discharge, at one month, (follow-up commitment). Secondary objectives are to further characterize adverse events (serious and non-serious), clinical utility measures, and health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 85 years of age
- •Male and Female
- •Patient/legal representative provides written informed consent
- •Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure
- •Patient is able to undergo emergent vascular surgery if a complication related to the VCD necessitates such surgery
- •Patient has a 6 french arterial puncture located in the common femoral artery
- •Target vessel has a lumen diameter ≥ 5 mm
- •Patient is willing and able to complete follow-up
- •Catheterization procedure is planned and elective
排除标准
- •Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the cardiac or peripheral catheterization procedure
- •Patients with a history of significant bleeding or with any known or documented bleeding disorders, such as Thrombocytopenia (with < 100,000 platelet count), Von Willebrand's disease, anemia (Hgb < 10 g/dL, Hct < 30%), thrombasthenia, decreased fibrinogen (< 200 mg/dL), and Factor V deficiency
- •Acute ST-elevation myocardial infarction ≤ 48 hours prior to the cardiac or peripheral catheterization procedure
- •Patient is ineligible for in-lab catheterization lab introducer sheath removal
- •Concurrent participation in another investigational device or drug trial
- •Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
- •Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure
- •Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery
- •The targeted femoral artery is tortuous or requires a sheath length > 10 cm
- •Patient is pregnant or breastfeeding
结局指标
主要结局
Treatment success
时间窗: 30 days post-index procedure
Composite of (1) procedural technical success (successful vascular access and ABS-6 delivery, deployment and catheter removal), (2) absence of vascular complications (arteriovenous fistula, femoral neuropathy, hematoma \>6cm, hemorrhage, infection, lymphocele, thrombosis/occlusion/distal emboli/stenosis, vascular injury) (3) absence of major adverse events (all-cause death, cardiac morbidity, neurological complications, renal failure, respiratory complications, secondary intervention for groin complications)
次要结局
- Estimated blood loss during index procedure(Intraoperative)
- Number of Adverse events(30 days post-index procedure)
- Time to hemostasis after index procedure(Intraoperative)
- Analgesic usage after index-procedure(1-day post-index procedure)
- Volume of contrast media used during index procedure(Intraoperative)
- Fluoroscopy time during index procedure(Intraoperative)
- Total procedure time of index procedure(Intraoperative)
- Pain Evaluation(1-day post-index procedure and 1 month follow-up)
- Anesthesia time of index procedure(Intraoperative)
- Total time of initial hospitalization stay(Up to 1 month post-index procedure)