Prospective, Multicenter, Single Arm, Pre-CE Marked Study of the AbsorbaSeal (ABS 5.6.7) Vascular Closure Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ID3 Medical
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Rate of major complications
研究概览
简要总结
This study investigates the efficacy and safety of the AbsorbaSeal (ABS 5.6.7.) 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 ABS 5.6.7. VCD in sealing the femoral arterial access site following diagnostic or interventional peripheral or coronary 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 safer, faster, and more secure hemostasis following these procedures. Due to its automatic deployment feature and simplicity in operation. AbsorbaSeal (ABS 5.6.7) will lead to more widespread use and improve patient outcomes. The active closure system used in the ABS 5.6.7 ensures a secure closure. 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.
Extensive laboratory testing, acute animal labs and deployment in chronic animal studies were performed with ABS 6. After a few device modification to create the improved ABS 5.6.7, only minimal confirmatory testing was performed with the current, modified ABS 5.6.7. The extensive test results on the previous device iterations are used to complete the confirmatory testing of the ABS 5.6.7 design.
The First in Man (FIM) trial (CP001) supports the initial safety and effectiveness of ABS 5.6.7 in humans (n=20) and was completed prior to application for a pivotal Investigational Device Exemption (IDE) Study in the United States and a CE Mark Study approval (CP004CE) in the European Union.
The primary objective of this study is to assess the safety and effectiveness of the ABS 5.6.7. 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, minimum age of 18
- •Patient provides written Informed Consent
- •Patient is scheduled for a 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 6French arterial puncture located in the common femoral artery (CFA)
- •Target vessel has a lumen diameter > 5 mm
- •Patient is willing and able to comply with all Study visits and procedures and complete follow-up visit
- •Catheterization procedure is planned and elective
- •Pre-Procedure
排除标准
- •Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the peripheral catheterization procedure
- •History of significant bleeding or with any known or documented bleeding disorders, such as thrombocytopenia (with < 100,000 platelet count), von Willebrand 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 peripheral catheterization procedure
- •Ineligible for introducer sheath removal
- •Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the peripheral catheterization procedure
- •Evidence of a preexisting hematoma, arteriovenous fistula, or pseudo-aneurysm 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
- •Targeted femoral artery is tortuous or requires a sheath length > 10 cm
- •Pregnant or lactating
- •Mean body mass index (BMI) > 35 kg/m²
- •Existing nerve damage in ipsilateral limb
- •Fibrotic, heavily calcified femoral artery within 10mm of the entry point
- •Non-palpable pulses in affected access limb
- •Intra-Procedure Exclusion Criteria:
- •Difficult insertion of procedural sheath, needle stick problems at the onset of the peripheral procedure or difficult insertion of ABS 5.6.7
- •Procedural sheath placement either through superficial femoral artery or into the profunda femoris artery or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery
- •Common femoral artery (CFA) puncture site located above the lowest sweep of the inferior epigastric artery; referred to as a "high stick"
- •Common femoral artery (CFA) access puncture site located on the front wall that continues through the back wall of the targeted vessel; referred to as a "back wall stick"
- •Common femoral artery (CFA) access puncture site with multiple punctures of the CFA in an attempt to gain access to the targeted vessel known as "multiple sticks"
- •Common femoral artery (CFA) access puncture located in the side wall region of the targeted access vessel; referred to as a "side wall stick"
- •Interventional procedures with multiple exchanges during the procedure that cause elongation and trauma to the vessel compromising the tight seal between the vessel and the sheath
- •Hematoma developing during the course of the percutaneous procedure
结局指标
主要结局
Rate of major complications
时间窗: Post-procedure follow up 30 ± 7 days
Composite of (1) closure-related bleeding requiring transfusion, (2) closure related vascular injury requiring repair surgery, (3) new ipsilateral lower extremity ischemia causing a threat to viability of limb requiring surgical or endovascular intervention, (4) closure-related infection requiring intravenous antibiotics and/or extended hospitalization, (5) new onset closure-related neuropathy in the ipsilateral lower extremity requiring surgical repair, and (6) permanent closure-related nerve damage.
Time to hemostasis (TTH) after index procedure (min)
时间窗: Intraoperative
TTH is defined as elapsed time between ABS 5.6.7 removal and first observed hemostasis
次要结局
- Device success(Within 5 minutes following ABS 5.6.7 deployment)
- Procedure success(Post-procedure follow up 30 ± 7 days)
- Rate of minor complications(Post-procedure follow up 30 ± 7 days)