A Multi-Center, Prospective, Randomized, Controlled, Trial to Evaluate the Safety and Efficacy of the Cardiva VASCADE VCS vs. Manual Compression for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 42
- 主要终点
- Time to Hemostasis (TTH)
研究概览
简要总结
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.
详细描述
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing femoral arterial access sites and providing reduced times to hemostasis and ambulation compared with manual compression at the completion of diagnostic or interventional endovascular procedures performed through 6 Fr or 7 Fr introducer sheaths. Subjects will be randomized in a 2:1 treatment device to control ratio.
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
- 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 undergoing an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 6 or 7 Fr introducer sheath
- •Pre-Operative
排除标准
- •Advanced refusal of blood transfusion, if necessary;
- •Active systemic or a cutaneous infection or inflammation;
- •Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- •Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count < 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
- •Severe co-existing morbidities having a life expectancy of less than 30 days;
- •Currently involved in any other investigational clinical trial;
- •Ipsilateral femoral arteriotomy within the previous 30 days;
- •Planned endovascular procedure within the next 30 days;
- •Previous ipsilateral femoral artery closure using a permanent implant-based closure device;
- •Previous vascular grafts or surgery at the target vessel access site;
- •History of symptomatic peripheral arterial disease, revascularization or deep vein thrombosis in the ipsilateral limb;
- •Unilateral or bilateral lower extremity amputation(s);
- •Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
- •Renal insufficiency (serum creatinine of > 2.5 mg/dl);
- •Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;
- •Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2);
- •Unable to routinely walk at least 20 feet without assistance (see protocol);
- •Known allergy/adverse reaction to bovine derivatives, sodium hyaluronate or hyaluronan preparations;
- •Procedures that extend hospitalization (e.g., staged endovascular procedure, CABG);
- •Administration of low molecular weight heparin (LMWH) within 8 hours of the procedure.
- •Intra-op Exclusion Criteria
- •An introducer sheath with an overall length greater than 11 cm, or not 6 Fr or 7 Fr diameter;
- •Femoral artery diameter less than 6 mm at access site;
- •Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, "back wall stick", etc.);
- •Angiographic evidence of more than minimal calcium, atherosclerotic disease, or stent within 1 cm of the puncture site;
- •Overlapping Common Femoral Vein and Femoral Artery at access site;
- •Placement of ipsilateral venous sheath during procedure;
- •Arterial access site located not at common femoral artery (e.g., on or below the bifurcation, above the lower border of the inferior epigastric artery, or above the pelvic brim);
- •More than one access site required;
- •Loss of distal pulses in the ipsilateral extremity during the procedure;
- •Subjects receiving unfractionated heparin with an ACT greater than 300 seconds in the absence of a glycoprotein IIb/IIIa inhibitor or greater than 250 seconds in the presence of a glycoprotein IIb/IIIa inhibitor (may wait to remove introducer sheath until ACT level reaches the target value);
- •Intra-procedural bleeding around sheath, or suspected intraluminal thrombus, hematoma, pseudoaneurysm, or AV fistula;
- •Systemic hypertension (BP greater than 180/110 mmHg) or hypotension (BP less than 90/60 mmHg) prior to randomization;
- •Length of the tissue tract, the distance between the anterior arterial wall and skin, is estimated to be less than 2.5 cm;
- •If the physician deems that a different method should be used to achieve hemostasis of the arterial site or that the subject should not attempt ambulation according to the protocol requirements.
结局指标
主要结局
Time to Hemostasis (TTH)
时间窗: Up to 1 hour
Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.
Rate of Combined Access Site-related Major Complications
时间窗: 30 days +/- 7 days
Primary safety endpoint * Access site-related bleeding requiring transfusion; * Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft); * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.; * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization; * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair; * Permanent access site-related nerve injury. (\> 30 days)
次要结局
- Time to Ambulation (TTA)(Up to 1 day)
- Device Success(Up to 1 day)
- Rate of Combined Minor Access Site Complications(30 days +/- 7 days)
- Time to Discharge Eligibility (TTDE)(Up to 2 days)
- Time to Hospital Discharge (TTHD)(Up to 2 days)
- Procedure Success(30 days +/- 7 days)