Clinical trial NCT00574691: ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EU
Official title: ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Coronary Arteriosclerosis
Keywords: Closure Device
Angiography
Angioplasty
Hemostasis
Heart Catheterization
Coronary Angiography
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to hemostasis and time to ambulation.
timeFrame: at time introducer sheath is removed
measure: Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia.
timeFrame: 30 days
Secondary outcomes:
measure: Device success.
timeFrame: initial hemostasis time ≤ 5 minutes and removal of the intact delivery system
measure: Procedural success.
timeFrame: 30 days
measure: Time the patient is deemed eligible for hospital discharge.
timeFrame: time of the access site closure until patient is discharge
measure: Rebleeding following initial hemostasis requiring a subsequent intervention.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Pseudoaneurysm not requiring treatment.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Pseudoaneurysm treated with ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Arteriovenous fistula documented by ultrasound or CT scan.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Access site hematoma ≥ 6 cm.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Post-hospital discharge access site-related bleeding.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Access site-related bleeding requiring > 30 minutes to achieve hemostasis.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Ipsilateral lower extremity arterial emboli.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Transient loss of ipsilateral lower extremity pulse.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Ipsilateral deep vein thrombosis.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Access site-related vessel laceration.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Transient access site-related nerve injury
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Access site wound dehiscence.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Localized access site infection treated with oral antibiotics.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Retroperitoneal bleeding.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Ipsilateral peripheral artery total occlusion.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Ecchymosis ≥ 6 cm.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Intraluminal plug delivery not requiring surgical intervention.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Decrease in pedal pulse.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
measure: Death.
timeFrame: prior to hospital discharge, and at the 30-day follow-up
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum NRW
Study officials:
affiliation: Herz-und Diabeteszentrum NRW
name: Marcus Wiemer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.