Condition or disease | Intervention/treatment | Phase |
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Endovascular | Device: MynxGrip Other: Manual compression | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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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.
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Device: MynxGrip
Vascular Closure
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Active Comparator: Manual compression
Manual compression hemostasis
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Other: Manual compression
Manual compression is a commonly used method to achieve hemostasis of femoral artery
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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 |
Inclusion Criteria:
Exclusion Criteria:
Patients are proved to have clinically significant peripheral vascular disease according to any of the following situations:
Contact: Janelle Noble | 612-210-0901 | janelle.noble@cardinalhealth.com | |
Contact: Renee Ma | 862132797223 | renee.ma@cardinalhealth.com |
China | |
Beijing Tiantan Hospital Capitol Medical University | Recruiting |
Beijing, China, 100068 | |
Contact: Miao zhongrong 1360124329 |
Principal Investigator: | Prof. Miao Zhongrong, MD | Beijing Tian Tan Hospital, Capital Medical University |
Tracking Information | |||||||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE | Endovascular | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Cordis Corporation | ||||||||
Study Sponsor ICMJE | Cordis Corporation | ||||||||
Collaborators ICMJE | Cardinal Health | ||||||||
Investigators ICMJE |
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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 |