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

Cordis

Status and phase

Completed

Phase 1

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Coronary Arteriosclerosis

Treatments

Device: 7F Ensure Medical Vascular Closure Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00574691

EM 06-01EU

Details and patient eligibility

About

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

Full description

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.

Enrollment

93 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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