ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EU - Full Text View

Sponsor:	Ensure Medical
Information provided by:	Ensure Medical
ClinicalTrials.gov Identifier:	NCT00574691

Purpose

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

Condition	Intervention	Phase
Angioplasty, Transluminal, Percutaneous Coronary Coronary Arteriosclerosis	Device: 7F Ensure Medical Vascular Closure Device	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis) Trial

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Methamphetamine

U.S. FDA Resources

Further study details as provided by Ensure Medical:

Primary Outcome Measures:

Time to hemostasis and time to ambulation. [ Time Frame: at time introducer sheath is removed ] [ Designated as safety issue: No ]
Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Device success. [ Time Frame: initial hemostasis time ≤ 5 minutes and removal of the intact delivery system ] [ Designated as safety issue: No ]
Procedural success. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Time the patient is deemed eligible for hospital discharge. [ Time Frame: time of the access site closure until patient is discharge ] [ Designated as safety issue: No ]
Rebleeding following initial hemostasis requiring a subsequent intervention. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Pseudoaneurysm not requiring treatment. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Pseudoaneurysm treated with ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Arteriovenous fistula documented by ultrasound or CT scan. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Access site hematoma ≥ 6 cm. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Post-hospital discharge access site-related bleeding. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Access site-related bleeding requiring > 30 minutes to achieve hemostasis. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Ipsilateral lower extremity arterial emboli. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Transient loss of ipsilateral lower extremity pulse. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Ipsilateral deep vein thrombosis. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Access site-related vessel laceration. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Transient access site-related nerve injury [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Access site wound dehiscence. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Localized access site infection treated with oral antibiotics. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Retroperitoneal bleeding. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Ipsilateral peripheral artery total occlusion. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Ecchymosis ≥ 6 cm. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Intraluminal plug delivery not requiring surgical intervention. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Decrease in pedal pulse. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]
Death. [ Time Frame: prior to hospital discharge, and at the 30-day follow-up ] [ Designated as safety issue: Yes ]

Enrollment:	93
Study Start Date:	June 2007
Study Completion Date:	October 2007

Arms	Assigned Interventions
1 Vascular Closure Device	Device: 7F Ensure Medical Vascular Closure Device Vascular Closure Device

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574691

Locations

Germany
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545

Sponsors and Collaborators

Ensure Medical

Investigators

Principal Investigator:

Marcus Wiemer, Dr.

Herz-und Diabeteszentrum NRW

More Information

No publications provided

Responsible Party:	Cordis ( Dr. Hans-Peter Stoll - Director Clinical Affairs )
Study ID Numbers:	EM 06-01EU
Study First Received:	December 13, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00574691 History of Changes
Health Authority:	Germany: German Institute of Medical Documentation and Information

Keywords provided by Ensure Medical:

Closure Device
Angiography
Angioplasty

Hemostasis
Heart Catheterization
Coronary Angiography

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Coagulants
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Arteriosclerosis

Hemostatics
Pharmacologic Actions
Coronary Disease
Therapeutic Uses
Cardiovascular Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 30, 2009