EndovascularPANDANCT03923387

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

A study testing MynxGrip and Manual compression in people with Endovascular, run by Cordis US Corp. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Endovascular
What is being tested?: MynxGrip and Manual compression
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 306 participants
Where: 1 siteChina
Study dates: 24 Apr 2019to 22 Oct 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
Patients who are able to walk, as judged by the investigators.

Who cannot join

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);

Show all 37Show fewer

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;
Patients with known allergy to polyethylene glycol;
Patients with treated but still uncontrolled hypertension (systolic pressure>180 mmHg or diastolic pressure>110 mmHg);
Patients with known autoimmune diseases;
Patients who are receiving long-term corticosteroid therapy;
Patients with expected life of less than 30 days;
Patients with unilateral or bilateral lower-extremity amputation;
Patients who can't walk 6 meters (20 steps) without a support for any reason;
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];
Patients with mental disorders and cognitive impairment;
Patients have participated into this study before; Intra-operative exclusion criteria;
Patients with treated but still uncontrolled hypertension (systolic pressure>180 mmHg or diastolic pressure>110 mmHg);
Patients implanted with a balloon pump inside the aorta;
Patients whose common femoral artery is too thin (<5 mm in diameter);
Patients with obviously fibrotic, calcified, or >50% stenotic femoral artery;
Patients having received puncture at other artery than the common femoral artery;
Patients having received antegrade puncture;
Patients having received arterial puncture at a number of different sites or who are suspected to have received posterior femoral arterial wall puncture;
Patients implanted with ipsilateral venous sheath;
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);
Patients with preexisting hematoma, intraluminal thrombus, pseudoaneurysm, AV Fistula or any type of dissection;
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];
Patients who are included in another drug or medical device study.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tiantan Hospital Capitol Medical University
Beijing, 100068

Other trials in China

About this study

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)

Read the 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.

Conditions: Endovascular
Being tested: MynxGrip, Manual compression
Keywords: Vascular closure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MynxGripDevice
Vascular Closure
Manual compressionOther
Manual compression is a commonly used method to achieve hemostasis of femoral artery

Study groups in NCT03923387
Study group	Role	What they receive
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. Receives: Device: MynxGrip
Manual compression	Active comparator	Manual compression hemostasis Receives: Other: Manual compression

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Effectiveness Endpoint: Time to Hemostasis
The time to hemostasis is defined as the time from the sheath removal to the time to achieving hemostasis for the subject. The "hemostasis" here refers to that at the puncture site, there is no pulsating bleeding, nor expansionary/progressive hematoma.
Measured: Post procedure (time from the sheath removal to the time to achieving hemostasis)
Primary Safety Endpoint: Major Complication Rate
Defined as major complications during procedure, at discharge, and 30 days post procedure: vascular injury or vascular repair required; Permanent access site-related nerve injury; Access site-related nerve injury requiring a surgery; Access site-related bleeding requiring transfusion; New ipsilateral lower extremity ischemia discovered, which requires invasive/noninvasive intervention; Local access site-related infection combined with other indicators, which requires intervention; Classic signs/symptoms occurred in a short time after receiving the specified hemostasis procedures and generalized infection with positive blood culture, sepsis, which requiring intervention; Inflammatory reaction, including the local reaction and discharge of pus, which requires intervention
Measured: Through 30 days post procedure

Secondary outcomes (5)

Secondary Effectiveness Endpoint: Time to Ambulation
Defined as the time (in minutes) from sheath removal to when the patient can walk about at least 6 meters (or 20 steps). Compare whether there are differences in the time to ambulation (for patients receiving a diagnostic procedure) between the two groups.
Measured: Post procedure
Secondary Effectiveness Endpoint: Length of Hospital Stay
Defined as the time (in minutes) from sheath removal to patient discharge (for patients receiving a diagnostic procedure). Compare whether there are differences in the length of stay (for patients receiving a diagnostic procedure) between the two groups.
Measured: Index procedure through discharge
Secondary Effectiveness Endpoint: Procedure Success Rate
Defined as successfully achieving hemostasis using the investigational medical device or control methods (including but are not limited to the assigned therapeutic method and other supplementary means) with absence of major complications. Compare whether there are differences in the procedure success rate (for patients receiving a diagnostic procedure) between the two groups.
Measured: Index procedure
Secondary Effectiveness Endpoint: Device Success Rate
Defined as the device being successfully removed in accordance with the standard operating procedure
Measured: Intraoperatively
Secondary Safety Endpoint: Minor Complication Rate
Compare whether there are differences in rates of minor complications between the two groups
Measured: Through 30 days post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 201922 Oct 2020

First posted22 Apr 2019
Study start24 Apr 2019
Primary completion22 Oct 2020
Study completion22 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EndovascularStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03923387
Sponsor's protocol ID: P17-0005
Acronym: PANDA
Status last verified: Jul 2026
First submitted: 17 Apr 2019
Last updated: 29 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Endovascular trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03923387
Acronym / sponsor ID: PANDA / P17-0005
Conditions: Endovascular
Keywords: Vascular closure
Study type: Interventional
Recruitment status: Completed
Enrolment: 306 participants (actual)
Lead sponsor: Cordis US Corp.Industry (pharma, biotech, devices)
Collaborators: Kun Tuo
Study start: 24 Apr 2019 (actual)
Primary completion: 22 Oct 2020 (actual)
Study completion: 22 Oct 2020 (actual)
First posted: 22 Apr 2019 (actual)
Results: Posted 29 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
MynxGrip	Experimental	Device: MynxGripMynxGrip, 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.
Manual compression	Active comparator	Other: Manual compressionManual compression hemostasis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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;
Patients who are able to walk, as judged by the investigators.

Key exclusion criteria (37 listed)

Patients are proved to have clinically significant peripheral vascular disease according to any of the following situations:
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MynxGripVascular Closure	Device	MynxGrip
Manual compressionManual compression is a commonly used method to achieve hemostasis of femoral artery	Other	Manual compression

Primary outcome

Primary Effectiveness Endpoint: Time to Hemostasis
Time frame: Post procedure (time from the sheath removal to the time to achieving hemostasis)
The time to hemostasis is defined as the time from the sheath removal to the time to achieving hemostasis for the subject. The "hemostasis" here refers to that at the puncture site, there is no pulsating bleeding, nor expansionary/progressive hematoma.
Primary Safety Endpoint: Major Complication Rate
Time frame: Through 30 days post procedure
Defined as major complications during procedure, at discharge, and 30 days post procedure: vascular injury or vascular repair required; Permanent access site-related nerve injury; Access site-related nerve injury requiring a surgery; Access site-related bleeding requiring transfusion; New ipsilateral lower extremity ischemia discovered, which requires invasive/noninvasive intervention; Local access site-related infection combined with other indicators, which requires intervention; Classic signs/symptoms occurred in a short time after receiving the specified hemostasis procedures and generalized infection with positive blood culture, sepsis, which requiring intervention; Inflammatory reaction, including the local reaction and discharge of pus, which requires intervention

5 secondary outcomes

Secondary Effectiveness Endpoint: Time to Ambulation
Time frame: Post procedure
Secondary Effectiveness Endpoint: Length of Hospital Stay
Time frame: Index procedure through discharge
Secondary Effectiveness Endpoint: Procedure Success Rate
Time frame: Index procedure
Secondary Effectiveness Endpoint: Device Success Rate
Time frame: Intraoperatively
Secondary Safety Endpoint: Minor Complication Rate
Time frame: Through 30 days post procedure

Results and safety

Results posted to the registry on 29 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MynxGrip	204	187
Manual Compression	102	92

Primary outcome: Primary Effectiveness Endpoint: Time to Hemostasis

Time frame: Post procedure (time from the sheath removal to the time to achieving hemostasis). Mean (Standard Deviation). Unit: Min

Measure	MynxGrip n = 197	Manual Compression n = 97
Value	4.8 (12.10)	19.8 (25.37)

Population analysed: The data represented here is the per-protocol population set, which includes all subjects from the full analysis set without major protocol deviation event affecting the effectiveness evaluation.

Primary outcome: Primary Safety Endpoint: Major Complication Rate

Time frame: Through 30 days post procedure. Number. Unit: percentage of participants

Measure	MynxGrip n = 204	Manual Compression n = 101
Value	0	0

Population analysed: The data represented here is the safety analysis set, which includes all subjects who were randomized into groups, received treatment, and have safety data after treatment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MynxGrip	10 of 204 (4.9%)	65 of 204 (31.9%)	0 of 204
Manual Compression	2 of 101 (2%)	20 of 101 (19.8%)	0 of 101

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof. Miao Zhongrong, MD principal investigator

Beijing Tian Tan Hospital, Capital Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MynxGrip and Manual compression in people with Endovascular, run by Cordis US Corp. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint: Time to Hemostasis (time frame: Post procedure (time from the sheath removal to the time to achieving hemostasis)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03923387.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.