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

NCT03923387 | Completed DMC FDA Device

• 1 other identifier: P17-0005
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

Endovascular

Keywords

Vascular closure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to ambulation

  At time of procedure through discharge (up to 3 days post procedure)

• Length of hospital stay

  Up to 5 days post procedure

• Procedure Success Rate

  Intraoperatively

Study Arms (2)

MynxGrip

EXPERIMENTAL

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

Manual compression

ACTIVE COMPARATOR

Manual compression hemostasis

Other: Manual compression

Interventions

MynxGrip DEVICE

Vascular Closure

MynxGrip

Manual compression OTHER

Manual compression is a commonly used method to achieve hemostasis of femoral artery

Manual compression

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cordis US Corp.: lead
• Cardinal Health: collaborator

Study Sites (1)

Beijing Tiantan Hospital Capitol Medical University

Beijing, 100068, China

Location

Study Officials

• Prof. Miao Zhongrong, MD

  Beijing Tian Tan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: May 7, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 22, 2022

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)