ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EU

Study Overview
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Brief Summary
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To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional procedures.

Detailed Description
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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.

Official Title
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ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis) Trial

Conditions
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Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis

Intervention / Treatment
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* Device: 7F Ensure Medical Vascular Closure Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is between 18 and 85 years of age Patient/legal representative provides written informed consent Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure Patient is able to undergo emergent vascular surgery if a complication related to the VCD necessitates such surgery Patient has a 7F arterial puncture located in the common femoral artery Target vessel has a lumen diameter ≥ 5 mm Patient is willing and able to complete follow-up Catheterization procedure is planned and elective Exclusion Criteria: Arterial puncture in the femoral artery of both legs Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the cardiac or peripheral catheterization procedure Patients with a history of significant bleeding or with any known or documented bleeding disorders, such as Thrombocytopenia (with < 100,000 platelet count), Von Willebrand's disease, anemia (Hgb < 10 g/dL, Hct < 30%), thrombasthenia, decreased fibrinogen (< 200 mg/dL), and Factor V deficiency Acute ST-elevation myocardial infarction ≤ 48 hours prior to the cardiac or peripheral catheterization procedure Uncontrolled hypertension (BP ≥ 180/110 mmHg) Heparinized patients with elevated pre-closure ACT level:> 250 seconds with GP IIb/IIIa inhibitor > 300 seconds no GP IIb/IIIa inhibitor Patient is ineligible for in-lab catheterization lab introducer sheath removal Concurrent participation in another investigational device or drug trial Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the cardiac or peripheral catheterization procedure Angiomax (bivalirudin) or other thrombin-specific anticoagulants or low molecular weight heparin ≤ 24 hours prior to the cardiac or peripheral catheterization procedure Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery The targeted femoral artery is tortuous or requires an introducer sheath length > 11 cm Fluoroscopically visible calcium, atherosclerotic disease, or stent ≤ 1 cm of the puncture site that would interfere with the placement of the VCD's plug Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture Antegrade puncture BMI > 40 kg/m2 Symptomatic leg ischemia in the target vessel limb including severe claudication (< 50 meter) or weak/absent pulse Targeted femoral artery diameter stenosis ≥ 50% Pre-existing severe non-cardiac systemic disease or pre-existing terminal illness Planned arterial access at the same access site ≤ 30 days following the femoral artery closure procedure Patient has known allergy to any materials used in the VCD Patient is known to require an extended hospitalization (e.g. patient is undergoing CABG surgery) Pre-existing systemic or cutaneous infection Prior or recent use of an intra-aortic balloon pump through the arterial access site Cardiogenic shock (hemodynamic instability requiring intravenous medications or mechanical support) experienced during or immediately post-catheterization Patient is unable to ambulate at baseline Patient is known or suspected to be pregnant, or is lactating Patient has already participated in this trial Patient has known allergy to contrast medium Patient is unavailable for follow-up Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the use of the VCD Required simultaneous ipsilateral or contralateral venous puncture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Vascular Closure Device | Device: 7F Ensure Medical Vascular Closure Device<br>* Vascular Closure Device<br>* Other names: Ensure Medical Vascular Closure Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis and time to ambulation. |  | 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. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success. |  | initial hemostasis time ≤ 5 minutes and removal of the intact delivery system | 
| Procedural success. |  | 30 days | 
| Time the patient is deemed eligible for hospital discharge. |  | time of the access site closure until patient is discharge | 
| Rebleeding following initial hemostasis requiring a subsequent intervention. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Pseudoaneurysm not requiring treatment. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Pseudoaneurysm treated with ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Arteriovenous fistula documented by ultrasound or CT scan. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Access site hematoma ≥ 6 cm. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Post-hospital discharge access site-related bleeding. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Access site-related bleeding requiring > 30 minutes to achieve hemostasis. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Ipsilateral lower extremity arterial emboli. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Transient loss of ipsilateral lower extremity pulse. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Ipsilateral deep vein thrombosis. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Access site-related vessel laceration. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Transient access site-related nerve injury |  | prior to hospital discharge, and at the 30-day follow-up | 
| Access site wound dehiscence. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Localized access site infection treated with oral antibiotics. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Retroperitoneal bleeding. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Ipsilateral peripheral artery total occlusion. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Ecchymosis ≥ 6 cm. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Intraluminal plug delivery not requiring surgical intervention. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Decrease in pedal pulse. |  | prior to hospital discharge, and at the 30-day follow-up | 
| Death. |  | prior to hospital discharge, and at the 30-day follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closure Device, Angiography, Angioplasty, Hemostasis, Heart Catheterization, Coronary Angiography