PANDAA Multicenter, Open Label, Prospective, Randomized Study of the MynxGrip Vascular Closure Device in Subjects With Diagnostic or Interventional Endovascular Procedures (PANDA Study)
MynxGrip
+ Manual compression
Treatment Study
Summary
Study start date: May 7, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.366 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Patients ≥ 18 years of age; 2. Patients who are able and willing to sign the informed consent form; 3. Patients who agree to follow all study visits and procedures; 4. 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: 1. Patients are proved to have clinically significant peripheral vascular disease according to any of the following situations: 1. Patients showing severe claudication after walking less than 200 meters, 2. No palpable pulse on the patients' affected limbs, 3. Patients having received surgical procedures involving the ipsilateral common femoral artery 4. Patients having received percutaneous transluminal angioplasty (PTA), stent placement, or vascular graft in the ipsilateral common femoral artery; 2. Patients with morbid obesity (BMI \> 40 kg/m2); 3. Patients with a myocardial infarction (MI) with acute elevated ST segment ≤24 hours prior to procedure; 4. Patients with the prior procedure in the ipsilateral common femoral artery ≤30 days; 5. Patients having received ipsilateral vascular closure device; 6. 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%); 7. Patients with documented INR \> 1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitors; 8. Patients with symptoms of local infection or inflammation in the groin; 9. Patients who are participating in any other clinical studies on drugs or medical devices at the same time; 10. Patients who are pregnant or in lactation; 11. Patients with known allergy to contrast medium; 12. Patients with known allergy to polyethylene glycol; 13. Patients with treated but still uncontrolled hypertension (systolic pressure\>180 mmHg or diastolic pressure\>110 mmHg); 14. Patients with known autoimmune diseases; 15. Patients who are receiving long-term corticosteroid therapy; 16. Patients with expected life of less than 30 days; 17. Patients with unilateral or bilateral lower-extremity amputation; 18. Patients who can't walk 6 meters (20 steps) without a support for any reason; 19. Patients requiring prolonged length of stay \[For example, the patient will receive the coronary artery bypass grafting (CABG) or the patient plans to receive the CABG ≤30 days after the surgery\]; 20. Patients with mental disorders and cognitive impairment; 21. Patients have participated into this study before; Intra-operative exclusion criteria; 22. Patients with treated but still uncontrolled hypertension (systolic pressure\>180 mmHg or diastolic pressure\>110 mmHg); 23. Patients implanted with a balloon pump inside the aorta; 24. Patients whose common femoral artery is too thin (\<5 mm in diameter); 25. Patients with obviously fibrotic, calcified, or \>50% stenotic femoral artery; 26. Patients having received puncture at other artery than the common femoral artery; 27. Patients having received antegrade puncture; 28. Patients having received arterial puncture at a number of different sites or who are suspected to have received posterior femoral arterial wall puncture; 29. Patients implanted with ipsilateral venous sheath; 30. 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); 31. Patients with preexisting hematoma, intraluminal thrombus, pseudoaneurysm, AV Fistula or any type of dissection; 32. Patients requiring prolonged length of stay \[For example, the patient will receive the coronary artery bypass grafting (CABG) or the patient plans to receive the CABG ≤30 days after the surgery\]; 33. Patients who are included in another drug or medical device study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Beijing Tiantan Hospital Capitol Medical University
Beijing, ChinaOpen Beijing Tiantan Hospital Capitol Medical University in Google Maps