Endovascular
Conditions
Keywords
Vascular closure
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.
Interventions
DEVICEMynxGrip
Vascular Closure
OTHERManual compression
Manual compression is a commonly used method to achieve hemostasis of femoral artery
Sponsors
Cordis US Corp.
Kun Tuo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint: Time to Hemostasis | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoint: Time to Ambulation | Post procedure | 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. |
| Secondary Effectiveness Endpoint: Length of Hospital Stay | Index procedure through discharge | 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. |
| Secondary Effectiveness Endpoint: Procedure Success Rate | Index procedure | 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. |
| Secondary Effectiveness Endpoint: Device Success Rate | Intraoperatively | Defined as the device being successfully removed in accordance with the standard operating procedure |
| Secondary Safety Endpoint: Minor Complication Rate | Through 30 days post procedure | Compare whether there are differences in rates of minor complications between the two groups |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORProf. Miao Zhongrong, MD
Beijing Tian Tan Hospital, Capital Medical University
Participant flow
Recruitment details
Study enrollment began with first patient on 24-Apr-2019 and ended with last patient on 21-Sep-2020.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.8 Years STANDARD_DEVIATION 10.74 |
| BMI | 25.38 Kg/m^2 STANDARD_DEVIATION 3.092 |
| Height | 1.661 m STANDARD_DEVIATION 0.0741 |
| Race/Ethnicity, Customized Han | 288 Participants |
| Race/Ethnicity, Customized Other | 16 Participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 32 Participants |
| Weight | 69.44 Kg STANDARD_DEVIATION 10.569 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 204 | 0 / 101 |
| other Total, other adverse events | 65 / 204 | 20 / 101 |
| serious Total, serious adverse events | 10 / 204 | 2 / 101 |
Outcome results
None listed