To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional procedures.
Multi-center (up to 6 European sites), non-blinded, non-randomized, feasibility study with a 2-month enrollment period and 30-day clinical follow-up. 60 patients (plus up to 36 "roll-in" device training patients) undergoing diagnostic or interventional coronary or peripheral procedures utilizing a 7F arterial puncture in the common femoral artery. Patients are excluded if they have a previous target artery closure with any closure device, recent myocardial infarction or thrombolytic therapy, treatment with thrombin-specific anticoagulants or low molecular weight heparin, fluoroscopically visible calcium or atherosclerosis ≤ 1 cm of puncture site, or planned target site access ≤ 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Vascular Closure Device
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Time to hemostasis and time to ambulation.
Time frame: at time introducer sheath is removed
Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia.
Time frame: 30 days
Device success.
Time frame: initial hemostasis time ≤ 5 minutes and removal of the intact delivery system
Procedural success.
Time frame: 30 days
Time the patient is deemed eligible for hospital discharge.
Time frame: time of the access site closure until patient is discharge
Rebleeding following initial hemostasis requiring a subsequent intervention.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Pseudoaneurysm not requiring treatment.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Pseudoaneurysm treated with ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Arteriovenous fistula documented by ultrasound or CT scan.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Access site hematoma ≥ 6 cm.
Time frame: prior to hospital discharge, and at the 30-day follow-up
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Post-hospital discharge access site-related bleeding.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Access site-related bleeding requiring > 30 minutes to achieve hemostasis.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Ipsilateral lower extremity arterial emboli.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Transient loss of ipsilateral lower extremity pulse.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Ipsilateral deep vein thrombosis.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Access site-related vessel laceration.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Transient access site-related nerve injury
Time frame: prior to hospital discharge, and at the 30-day follow-up
Access site wound dehiscence.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Localized access site infection treated with oral antibiotics.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Retroperitoneal bleeding.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Ipsilateral peripheral artery total occlusion.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Ecchymosis ≥ 6 cm.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Intraluminal plug delivery not requiring surgical intervention.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Decrease in pedal pulse.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Death.
Time frame: prior to hospital discharge, and at the 30-day follow-up