A Multicenter, Open Label, Prospective, Randomized Study of the MynxGrip Vascular Closure Device in Subjects With Diagnostic or Interventional Endovascular Procedures (PANDA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Time to hemostasis
研究概览
简要总结
To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery puncture site, compared with manual compression hemostasis in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.
详细描述
Effectiveness: to superiority to the control group in time to hemostasis. Comparison of time to ambulation, procedure success rate, length of stay in hospital, device success rate.
Safety-Major/Minor complication rate, adverse events, SAEs as compared to control.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age;
- •Patients who are able and willing to sign the informed consent form;
- •Patients who agree to follow all study visits and procedures;
- •Patients who plan to receive the diagnostic or interventional endovascular procedures via percutaneous common femoral artery puncture;
- •Patients who are able to walk, as judged by the investigators.
排除标准
- •Patients are proved to have clinically significant peripheral vascular disease according to any of the following situations:
- •Patients showing severe claudication after walking less than 200 meters,
- •No palpable pulse on the patients' affected limbs,
- •Patients having received surgical procedures involving the ipsilateral common femoral artery
- •Patients having received percutaneous transluminal angioplasty (PTA), stent placement, or vascular graft in the ipsilateral common femoral artery;
- •Patients with morbid obesity (BMI > 40 kg/m2);
- •Patients with a myocardial infarction (MI) with acute elevated ST segment ≤24 hours prior to procedure;
- •Patients with the prior procedure in the ipsilateral common femoral artery ≤30 days;
- •Patients having received ipsilateral vascular closure device;
- •Patients with bleeding disorders such as thrombocytopenia (platelet count < 100,000/ mm3), hemophilia, von Willebrand disease or severe anemia (Hgb < 10 g/dL, Hct < 30%);
- •Patients with documented INR > 1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitors;
- •Patients with symptoms of local infection or inflammation in the groin;
- •Patients who are participating in any other clinical studies on drugs or medical devices at the same time;
- •Patients who are pregnant or in lactation;
- •Patients with known allergy to contrast medium;
- •Patients with known allergy to polyethylene glycol;
- •Patients with treated but still uncontrolled hypertension (systolic pressure>180 mmHg or diastolic pressure>110 mmHg);
- •Patients with known autoimmune diseases;
- •Patients who are receiving long-term corticosteroid therapy;
- •Patients with expected life of less than 30 days;
- •Patients with unilateral or bilateral lower-extremity amputation;
- •Patients who can't walk 6 meters (20 steps) without a support for any reason;
- •Patients requiring prolonged length of stay [For example, the patient will receive the coronary artery bypass grafting (CABG) or the patient plans to receive the CABG ≤30 days after the surgery];
- •Patients with mental disorders and cognitive impairment;
- •Patients have participated into this study before; Intra-operative exclusion criteria;
- •Patients with treated but still uncontrolled hypertension (systolic pressure>180 mmHg or diastolic pressure>110 mmHg);
- •Patients implanted with a balloon pump inside the aorta;
- •Patients whose common femoral artery is too thin (<5 mm in diameter);
- •Patients with obviously fibrotic, calcified, or >50% stenotic femoral artery;
- •Patients having received puncture at other artery than the common femoral artery;
- •Patients having received antegrade puncture;
- •Patients having received arterial puncture at a number of different sites or who are suspected to have received posterior femoral arterial wall puncture;
- •Patients implanted with ipsilateral venous sheath;
- •Surgical findings or complications which the investigators consider may interfere with the patients' participation into the study (For example, the sheath deployment is difficult due to the scar, tortuous vessels, or use of the sheath with the other sizes than 5 Fr, 6 Fr or 7 Fr, or the sheath with the total length of >15.7 cm);
- •Patients with preexisting hematoma, intraluminal thrombus, pseudoaneurysm, AV Fistula or any type of dissection;
- •Patients requiring prolonged length of stay [For example, the patient will receive the coronary artery bypass grafting (CABG) or the patient plans to receive the CABG ≤30 days after the surgery];
- •Patients who are included in another drug or medical device study.
研究组 & 干预措施
MynxGrip
MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.
干预措施: MynxGrip (Device)
Manual compression
Manual compression hemostasis
干预措施: Manual compression (Other)
结局指标
主要结局
Time to hemostasis
时间窗: Intraoperatively
To evaluate whether the time to hemostasis for the puncture site of common femoral artery of the subjects in the MynxGrip group is superior to the control group. Determined using the following formula where time is measured in minutes. H0: ttest - tcontrol ≥ -5，H1: ttest - tcontrol \< -5
Primary Effectiveness Endpoint: Time to Hemostasis
时间窗: Post procedure (time from the sheath removal to the time to achieving hemostasis)
The time to hemostasis is defined as the time from the sheath removal to the time to achieving hemostasis for the subject. The "hemostasis" here refers to that at the puncture site, there is no pulsating bleeding, nor expansionary/progressive hematoma.
Primary Safety Endpoint: Major Complication Rate
时间窗: Through 30 days post procedure
Defined as major complications during procedure, at discharge, and 30 days post procedure: vascular injury or vascular repair required; Permanent access site-related nerve injury; Access site-related nerve injury requiring a surgery; Access site-related bleeding requiring transfusion; New ipsilateral lower extremity ischemia discovered, which requires invasive/noninvasive intervention; Local access site-related infection combined with other indicators, which requires intervention; Classic signs/symptoms occurred in a short time after receiving the specified hemostasis procedures and generalized infection with positive blood culture, sepsis, which requiring intervention; Inflammatory reaction, including the local reaction and discharge of pus, which requires intervention
次要结局
- Procedure Success Rate(Intraoperatively)
- Time to ambulation(At time of procedure through discharge (up to 3 days post procedure))
- Length of hospital stay(Up to 5 days post procedure)
- Secondary Effectiveness Endpoint: Time to Ambulation(Post procedure)
- Secondary Effectiveness Endpoint: Length of Hospital Stay(Index procedure through discharge)
- Secondary Effectiveness Endpoint: Procedure Success Rate(Index procedure)
- Secondary Effectiveness Endpoint: Device Success Rate(Intraoperatively)
- Secondary Safety Endpoint: Minor Complication Rate(Through 30 days post procedure)