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出境医 / 临床实验 / Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device (PANDA)

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

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 Intervention/treatment Phase
Endovascular Device: MynxGrip Other: Manual compression Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 7, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 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
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Ages Eligible for Study:   18 Years 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 < 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.
Contacts and Locations

Contacts
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Contact: Janelle Noble 612-210-0901 janelle.noble@cardinalhealth.com
Contact: Renee Ma 862132797223 renee.ma@cardinalhealth.com

Locations
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China
Beijing Tiantan Hospital Capitol Medical University Recruiting
Beijing, China, 100068
Contact: Miao zhongrong    1360124329      
Sponsors and Collaborators
Cordis Corporation
Cardinal Health
Investigators
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Principal Investigator: Prof. Miao Zhongrong, MD Beijing Tian Tan Hospital, Capital Medical University
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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
  • 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.
  • Procedure Success Rate [ Time Frame: Intraoperatively ]
    Chi-squared Test or Fisher's Exact Test is used, according to the distribution characteristics.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device
Official Title  ICMJE A Multicenter, Open Label, Prospective, Randomized Study of the MynxGrip Vascular Closure Device in Subjects With Diagnostic or Interventional Endovascular Procedures (PANDA Study)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Endovascular
Intervention  ICMJE
  • Device: MynxGrip
    Vascular Closure
  • Other: Manual compression
    Manual compression is a commonly used method to achieve hemostasis of femoral artery
Study Arms  ICMJE
  • 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.
    Intervention: Device: MynxGrip
  • Active Comparator: Manual compression
    Manual compression hemostasis
    Intervention: Other: Manual compression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
366
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Janelle Noble 612-210-0901 janelle.noble@cardinalhealth.com
Contact: Renee Ma 862132797223 renee.ma@cardinalhealth.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923387
Other Study ID Numbers  ICMJE P17-0005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cordis Corporation
Study Sponsor  ICMJE Cordis Corporation
Collaborators  ICMJE Cardinal Health
Investigators  ICMJE
Principal Investigator: Prof. Miao Zhongrong, MD Beijing Tian Tan Hospital, Capital Medical University
PRS Account Cordis Corporation
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP