eclipse feasibility trial (ensure's vascular closure device speeds hemostasis trial) eu

Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Arteriosclerosis

Summary: 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.

Eligibility criteria:
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

Keywords: closure device angiography angioplasty hemostasis heart catheterization coronary angiography