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

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

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.

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