Comparative Analysis of Thrombin Utilized in Endovascular Procedures of the Femoral Artery - CEASE Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 6
- 主要终点
- Time to Hemostasis
研究概览
简要总结
This trial is designed as a prospective, multi-center, randomized, double blinded clinical trial to evaluate the safety and efficacy of the Thrombin VSI. An immunological sub-study to assess antibody and coagulation changes in the subjects following exposure to the Vascular Solutions Diagnostic Duett Pro manufactured with Thrombin VSI and Thrombin JMI will be conducted as a component of this trial with a subset of the enrolled study subjects.
Two hundred seventy (270) subjects will be enrolled in this trial. A minimum of 50% of the subjects will be interventional subjects and up to 50% will be diagnostic subjects. All 270 subjects will provide blood specimens at baseline and at the 30 day follow-up visit for evaluation in the immunologic sub-study. Within the 270 subjects enrolled, a minimum of 45 subjects treated with the Thrombin VSI and a minimum of 45 subjects treated with the Thrombin JMI will provide blood specimens at the 60 day follow-up visit to be evaluated in the immunologic sub-study.
The primary efficacy objective is to demonstrate that the device time-to-hemostasis for the study group treated with the sealing device manufactured with Thrombin VSI is non-inferior to the study group treated with the sealing device manufactured with Thrombin JMI.
The primary safety objective is to demonstrate a device-related major complication rate for the study group treated with the sealing device manufactured with Thrombin VSI that is non-inferior to the device-related major complication rate observed for the study group treated with the sealing device manufactured with Thrombin JMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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
- •The subject is 18 years of age or older
- •The subject is undergoing a diagnostic or interventional endovascular procedure via a retrograde femoral arterial access
- •The subject is willing and able to provide appropriate informed consent
- •The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations
排除标准
- •Exclusion criteria determined prior to procedure:
- •The subject has a history of clinically severe peripheral vascular disease documented as any of the following:
- •Severe claudication (walking < 100 feet)
- •Absent pulses in the affected limb
- •ABI < 0.5 at rest
- •Known diameter stenosis ≥ 50% in the iliac or femoral artery on the affected side
- •Prior vascular bypass surgery involving the affected femoral artery
- •Prior stent placement in the vicinity of the arterial puncture site
- •The subject is known to be, or suspected to be, pregnant (verified in a manner consistent with institution's standard of care), or is lactating
- •The subject has a pre-existing severe non-cardiac systemic disease or pre-existing terminal illness
- •The subject has had an acute myocardial infarction ≤ 72 hours before the catheterization procedure
- •The subject is unable to ambulate at baseline
- •The subject is known to require an extended hospitalization (e.g., subject is undergoing CABG surgery)
- •The subject has a known bleeding disorder (including thrombocytopenia [< 100,000 platelet count], thrombobasthenia, hemophilia, or von Willebrand disease)
- •The subject is receiving Coumadin/warfarin therapy and has an INR > 2.0 on the day of, or the day before the study procedure. (INR of > 2.0 should not result in a dose change prior to the study procedure. If dosage changed, test should be repeated prior to the procedure)
- •The subject has a known allergy to bovine derived products or any other materials used in the Diagnostic Duett Pro Sealing Device
- •The subject has undergone prior use of a closure device in the ipsilateral common femoral artery ≤ 6 months before the current catheterization procedure
- •The subject has undergone prior use of manual compression for closure in the ipsilateral common femoral artery ≤ 6 weeks before the current catheterization procedure
- •The subject has undergone current, recent, or prior use of an intra-aortic balloon pump through the existing arterial puncture site
- •The subject is unavailable for follow-up
- •The subject is currently participating in another investigational device or drug trial
- •The subject has previously participated in this trial (Protocol 0106)
- •Exclusion criteria to be determined during the procedure:
- •The subject has an antegrade puncture
- •The subject's arterial introducer sheath is <5F or > 9F or longer than 15.2 cm in overall length
- •The subject has a suspected posterior femoral arterial wall puncture or puncture distal to the common femoral artery bifurcation
- •The subject's common femoral artery diameter is estimated to be < 6 mm via angiogram
- •The subject has tortuous vascular anatomy with greater than 90o bends on femoral angiogram
- •The subject is severely hypertensive (defined as systolic BP > 180 mmHg or diastolic BP > 110 mmHg)
- •The subject has experienced hemodynamic instability, defined as systolic blood pressure < 90 mmHg or cardiogenic shock, during or immediately post-procedure
- •The subject has been anticoagulated with unfractionated heparin and has an ACT of > 300 seconds at completion of the antecedent procedure
- •The subject is anticipated to continue dosing of heparin or anti-coagulant therapy (except any approved GPIIb/IIIa platelet receptor blocker) ≤ 6 hours following completion of the interventional or diagnostic procedure
- •The subject has received thrombolytic therapy (e.g., streptokinase, urokinase, or t-PA) ≤ 24 hours prior to the catheterization procedure
- •The subject has a large hematoma (≥ 6cm in diameter) present prior to vascular sealing.
结局指标
主要结局
Time to Hemostasis
Incidence rate of device-related major complications
次要结局
- Time to ambulation
- Procedure success
- Subject satisfaction
- Device success
- Minor complications