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

NCT ID: NCT00574691

Last Updated: 2012-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2007-10-31

Brief 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.

Detailed 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.

Conditions

Angioplasty, Transluminal, Percutaneous Coronary; Coronary Arteriosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Vascular Closure Device

Group Type: OTHER

7F Ensure Medical Vascular Closure Device

Intervention Type: DEVICE

Vascular Closure Device

Interventions

7F Ensure Medical Vascular Closure Device

Vascular Closure Device

Intervention Type: DEVICE

Other Intervention Names

Ensure Medical Vascular Closure Device

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Cordis

Principal Investigators

Marcus Wiemer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Herz-und Diabeteszentrum NRW

Locations

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Countries

Germany

References

Wiemer M, Langer C, Fichtlscherer S, Firschke C, Hofbauer F, Lins M, Haude M, Debefve C, Stoll HP, Hanefeld C. First-in-man experience with a new 7F vascular closure device (EXOSEAL): the 7F ECLIPSE study. J Interv Cardiol. 2012 Oct;25(5):518-25. doi: 10.1111/j.1540-8183.2012.00739.x. Epub 2012 Jul 5.

Reference Type: DERIVED

PMID: 22762417 (View on PubMed)

Other Identifiers

EM 06-01EU

Identifier Type: -

Identifier Source: org_study_id