Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter, Open Label, Prospective, Randomized Study of the MynxGrip Vascular Closure Device in Subjects With Diagnostic or Interventional Endovascular Procedures (PANDA Study)

Conditions
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Endovascular

Intervention / Treatment
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* Device: MynxGrip
* Other: Manual compression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 5) Patients who are able to walk, as judged by the investigators. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized parallel controlled trial, in which treatment is conducted simultaneously for both the test group and the control group, so that potential differences influencing the outcome measures between both groups can be minimized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MynxGrip<br>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. | Device: MynxGrip<br>* Vascular Closure<br>|
| Active Comparator: Manual compression<br>Manual compression hemostasis | Other: Manual compression<br>* Manual compression is a commonly used method to achieve hemostasis of femoral artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis | 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 | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ambulation | Compare whether there are statistical differences between the test and control group in the time to ambulation measured in hours and determined using a t-test analysis | At time of procedure through discharge (up to 3 days post procedure) | 
| Length of hospital stay | Compare whether there are statistical differences between the test and control group in the length of the hospital stay measured in hours and using a t-test analysis. | Up to 5 days post procedure | 
| Procedure Success Rate | Chi-squared Test or Fisher's Exact Test is used, according to the distribution characteristics. | Intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular closure