ACCESS: A Randomized, Multicenter, Single-Blinded Trial to Compare the Extrafemoral Closure Device Exo-Seal® and the Collagen-based Intravascular Device Angio-SealTM for Arterial Puncture Site Closure.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 6
- 主要终点
- bleeding, need for vascular surgery and device failure
研究概览
简要总结
Background:
Vascular closure devices (VCD) were developed to reduce access site bleedings, to improve patients´ comfort, and to accelerate ambulation after percutaneous coronary interventions (PCI). Despite higher complications rates in earlier studies, current data suggest similar complication rates or better outcomes after the use of VCD as compared to manual compression. ExoSeal (Cordis, Warren, NJ, USA) is a new, extravascular polyglycol acid (PGA) plug which occludes the puncture channel. Whether the use of this extravascular closure device is as effective as the more widely used plug/anchor mediated devices, has not been evaluated so far.
We performed a randomized, multicentre, single-blinded trial to compare the efficacy of the extravascular closure device ExoSeal in comparison to the collagen-based plug/anchor mediated AngioSeal system.
Methods:
304 patients receiving diagnostic angiography and/or PCI will be included in three centers. Exclusion criteria are contraindications for any VCD including 1. severe calcification of the access vessel, 2. severe peripheral artery disease, 3. puncture in the origin of the profound femoral artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the femoral or iliac artery, 5. marked obesity or cachexia (BMI >40 or <20) and 6. patients on continuous medication with oral anticoagulants.
After the procedure, angiography of the accessed femoral artery is performed to rule out major risk factors for retroperitoneal hemorrhage, relevant peripheral stenoses of the common or the superficial femoral artery, or a location of the puncture site in the bifurcation of the profundal femoral artery.
We hypothesise, that the use of an extravascular closure device is not inferior to an anchor/plug mediated device regarding the occurrence of the following complications: bleeding, need for vascular surgery and device failure (primary endpoints). Secondary endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device. Power was 80%, alpha 0.05. Bleeding will be defined according to the TIMI criteria. The study is actively enrolling patients, last inclusion will take place in September 2012.
Results and Conclusions:
Outcome data including the primary endpoint (bleeding, need for vascular surgery and device failure) will be presented for the first time.
详细描述
Introduction In patients undergoing percutaneous coronary interventions (PCI) there is a rate of vascular complications of 0.8% to 5.5% (1). Albeit femoral sheaths sizes were reduced, arterial compression and long-term dressing after PCI still bear tremendous discomfort and groin pain for the patients. Furthermore, manual compression of the puncture site should be performed until activated clotting time is below 180 seconds (2).
Therefore, vascular closure devices (VCD) were developed to reduce access site bleedings, to improve patients´ comfort, and to accelerate ambulation after PCI.
The hemostatic puncture closure device Angio-Seal (St. Jude Medical, St. Paul, MS, USA) is a collagen based plug system with an anchor in the inner vessel wall. ExoSeal (Cordis, Warren, NJ, USA) is a extravascular polyglycol acid (PGA) plug, which closes the puncture site on an extravascular basis while occluding the puncture channel.
The aim of the current, randomized study is, to evaluate the effectiveness, safety and reliability of 2 different vascular closure devices.
Methods Consecutive patients with stable angina pectoris or silent ischemia with a positive stress test will be randomized to either Angio-Seal or Exo-Seal, and included into the study after giving written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •all patients who receive coronary angiography/intervention with an 6 F sheath
排除标准
- •severe calcification of the access vessel,
- •severe peripheral artery disease,
- •puncture in the origin of the profound femoral artery,
- •non-femoral sheath insertion,
- •marked tortuosity of the femoral or iliac artery,
- •marked obesity or cachexia (BMI >40 or <20)
- •patients on continuous medication with oral anticoagulants.
研究组 & 干预措施
Exo Seal system
Percutaneous coronary intervention
干预措施: percutaneous coronary intervention (Device)
AngioSeal system
percutaneous coronary intervention
干预措施: percutaneous coronary intervention (Device)
结局指标
主要结局
bleeding, need for vascular surgery and device failure
时间窗: 24 hours
bleeding, need for vascular surgery and device failure will be measured as primary endpoints within the first 24 hours.
次要结局
- occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device.(24 hours)
研究者
Harald Rittger
Priv.-Doz. Dr. Harald Rittger
University Hospital Erlangen