This study is designed to evaluate the efficacy (device deployment characteristics and performance) and safety (adverse access site related events) of Perclose ProGlide (Abbott Vascular Devices) for femoral access site closure in patients undergoing peripheral vascular diagnostic and interventional procedures in comparison with Angio-seal VIP (St. Jude Medical).
Prospective, single-center, randomized (1:1), open-label, non-inferiority study in 1062 patients comparing Perclose ProGlide (test device) to the Angio-seal VIP (standard comparator).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,062
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide.
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGIncidence of the device successfully deployed and absence of the major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.) at 30 days
Deployment procedure success is defined as haemostasis after the delivery and release of a closure device, manual compression is no longer needed or less than 5 minutes, and no more closure devices are needed. Major vascular complications include: 1. Vascular injury related to access site requiring surgical or percutaneous intervention, or ultrasound guided compression, or thrombin injection. 2. New onset lower extremity ischemia attributed to arterial access or closure, and/or the ABI of the ipsilateral limb of access site decreased by ≥0.15 or requiring surgical or additional percutaneous intervention. 3. haemorrhage related to access site requiring transfusion, or haemoglobin decreased by ≥5g/dl or hematocrit (HCT) decreased by ≥15% 4. Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with intravenous antibiotics. 5. Nerve injury related to access site which is permanent or requires surgery.
Time frame: 30 days post procedure
Minor ipsilateral access site complications at 30 days and generally no aggressive treatment is required
Minor ipsilateral access site vascular complications included: 1. Access site pseudoaneurysm or AV fistula documented by ultrasound, neither surgical nor percutaneous intervention is required. 2. Post-discharge access site-related haemorrhage requiring ≥ 30 minutes manual compression to re-achieve hemostasis. 3. Lower extremity arterial stenosis attributed to arterial access or closure, whereas neither surgical nor percutaneous intervention is required. 4. haemorrhage related to access site with no transfusion required. while, transfusion is required when haemoglobin decreased by \<5g/dl or hematocrit (HCT) decreased by \<15%. 5. Access site hematoma ≥ 6 cm, neither blood transfusion nor surgical intervention is required. 6. Localized access site infection treated with intramuscular or oral antibiotics. 7. Transient access site-related nerve injury.
Time frame: 30 days post procedure
Incidence at 180 days of the composite endpoint of major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.)
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Major vascular complications include: 1. Vascular injuries related to access site requiring surgical or percutaneous intervention, or ultrasound guided compression, or thrombin injection. 2. New onset lower extremity ischemia that is attributed to arterial access or closure, and the ABI of the ipsilateral limb of access site decreased by ≥0.15 or requiring surgical or additional percutaneous intervention. 3. Bleeding related to access site requiring transfusion or haemoglobin decreased by ≥5g/dl or hematocrit (HCT) decreased by ≥15% 4. Infection requiring a extended hospitalization for more than 24 hours or a new hospitalization or treatment with intravenous antibiotics. 5. Nerve injury related to access site is permanent or requires surgery.
Time frame: 180 days post procedure
Deployment procedure time
Deployment procedure time was defined as elapsed time from the first skin break to final closure (skin to skin time)
Time frame: within 24 hours of device deployment
Time to haemostasis from removing the sheath until haemostasis
Haemostasis is considered as insignificant bleeding on the bandage or small continuous oozing, manual compression is no longer needed or less than 5 minutes.
Time frame: within 24 hours of device deployment
Patients' comfort level during the deployment of the closure device using the visual analog scale (VAS)
0 cm means no pain, while 10 cm means the worst imaginable pain or the worst pain one had experienced
Time frame: within 5 minutes of device deployment