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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03923387

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted August 5, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Endovascular
  • Intervention/Treatment: Device: MynxGrip
    Other: Manual compression
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 366 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention 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) ()
  • Primary Purpose: Treatment
  • Official Title: A Multicenter, Open Label, Prospective, Randomized Study of the MynxGrip Vascular Closure Device in Subjects With Diagnostic or Interventional Endovascular Procedures (PANDA Study)
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Experimental: 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.
Device: MynxGrip
Vascular Closure
Active Comparator: Manual compression
Manual compression hemostasis
Other: Manual compression
Manual compression is a commonly used method to achieve hemostasis of femoral artery
Outcome Measures
  • Primary Outcome Measures: 1. Time to hemostasis [ Time Frame: 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
  • Secondary Outcome Measures: 1. Time to ambulation [ Time Frame: At time of procedure through discharge (up to 3 days post procedure) ]
    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
  • 2. Length of hospital stay [ Time Frame: Up to 5 days post procedure ]
    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.
  • 3. Procedure Success Rate [ Time Frame: Intraoperatively ]
    Chi-squared Test or Fisher's Exact Test is used, according to the distribution characteristics.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 100 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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 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 (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.

Contacts and Locations
Contacts

Contact: Janelle Noble 612-210-0901 janelle.noble@cardinalhealth.com

Contact: Renee Ma 862132797223 renee.ma@cardinalhealth.com

Locations

China
Beijing Tiantan Hospital Capitol Medical University
Beijing

Sponsors and Collaborators

Cordis Corporation

Cardinal Health

Investigators

Principal Investigator: Prof. Miao Zhongrong, MD Beijing Tian Tan Hospital, Capital Medical University

More Information
  • Responsible Party: Cordis Corporation
  • ClinicalTrials.gov Identifier: NCT03923387 History of Changes
  • Other Study ID Numbers: P17-0005
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: August 5, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Cordis Corporation: Vascular closure